Trial Outcomes & Findings for Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer (NCT NCT05628363)
NCT ID: NCT05628363
Last Updated: 2026-07-02
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
From start of radiotherapy through 90 days after start of radiotherapy
Results posted on
2026-07-02
Participant Flow
Participant milestones
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Physician Decision
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2
|
Baseline Characteristics
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
n=28 Participants
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
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Age, Continuous
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69 years
n=20 Participants
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|
Sex: Female, Male
Female
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0 Participants
n=20 Participants
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|
Sex: Female, Male
Male
|
28 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
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Race (NIH/OMB)
Black or African American
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
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Region of Enrollment
United States
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28 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From start of radiotherapy through 90 days after start of radiotherapyPopulation: Participants who received at least 1 fraction of adaptive SBRT.
Outcome measures
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
n=25 Participants
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
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Number of Participants With Acute Grade ≥3 GI and GU Adverse Events
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1 Participants
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SECONDARY outcome
Timeframe: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24-The EPIC-26 is used to assess health related quality of life among persons with prostate cancer. It contains 5 domains of urinary incontinence, urinary irritability/obstructive, bowel, sexual, and hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24-The EQ-5D-5L is a commonly used and reliable questionnaire used to assess patient perception of their current health state. Patients are asked about their levels of difficulty with mobility, self-care, and usual activities, and about their pain/discomfort and anxiety/depression levels on a 5-point scale where the response "I have no problems" = 1 and "I am unable/have extreme" = 5.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of radiotherapy through 90 days after start of radiotherapyPopulation: Participants who received at least 1 fraction of adaptive SBRT
Outcome measures
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
n=25 Participants
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
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Number of Participants With Acute Grade ≥3 Adverse Events at Least Possibly Related to Radiotherapy
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1 Participants
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SECONDARY outcome
Timeframe: From start of radiotherapy through 90 days after start of radiotherapyPopulation: Participants who received at least 1 fraction of adaptive SBRT
Outcome measures
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
n=25 Participants
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
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Number of Participants With Acute <Grade 3 GI and GU Adverse Events
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24 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: From day 91 after the start of radiotherapy until completion of follow-up at month 60Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of radiotherapy until completion of follow-up (estimated to be 60 months)-Time from start of radiotherapy to biochemical relapse, radiographic recurrence with development of local, regional or distant metastases, or death to due to any cause
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of radiotherapy until completion of follow-up (estimated to be 60 months)* Biochemical recurrence free survival: Defined as a \>2 ng/mL rise in the PSA above the nadir post initial treatment or evidence of radiographic progression. * Time from start of radiotherapy to recurrence of prostate cancer by PSA criteria or radiographically)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of radiotherapy until completion of follow-up (estimated to be 60 months)-Time from start of radiotherapy to death from any cause
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of radiotherapy until completion of follow-up (estimated to be 60 months)-Time from start of radiotherapy treatment to radiographic diagnosis of metastatic disease (M1 disease) or death from any cause
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of radiotherapy until completion of follow-up (estimated to be 60 months)-Time from start of radiotherapy to death due to prostate cancer.
Outcome measures
Outcome data not reported
Adverse Events
Adaptive Stereotactic Body Radiotherapy (SBRT)
Serious events: 2 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
n=25 participants at risk
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
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Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
General disorders
Death NOS
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
Other adverse events
| Measure |
Adaptive Stereotactic Body Radiotherapy (SBRT)
n=25 participants at risk
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
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|---|---|
|
Gastrointestinal disorders
Acute - Abdominal Pain
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Abdominal Pain
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Anal Fissure
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Anal Fissure
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Anal Fistula
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Colitis
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Constipation
|
16.0%
4/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Constipation
|
32.0%
8/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Diarrhea
|
32.0%
8/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Diarrhea
|
32.0%
8/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Dyspepsia
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Hemorrhoids
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late- Hemorrhoids
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Nausea
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late- Nausea
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Proctitis
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late- Proctitis
|
8.0%
2/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Rectal Hemorrhage
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Rectal Hemorrhage
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Rectal Mucositis
|
16.0%
4/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Rectal Mucositis
|
8.0%
2/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Acute - Rectal Pain
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late- Rectal Pain
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Rectal Urgency
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Gastrointestinal disorders
Late - Vomiting
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Infections and infestations
Acute - Urinary Tract Infection
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Hematuria
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Hematuria
|
8.0%
2/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Difficulty Urinating
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Dysuria
|
36.0%
9/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Dysuria
|
36.0%
9/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Renal Calculi
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Urinary Hesitancy
|
16.0%
4/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Urinary Hesitancy
|
12.0%
3/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Urinary Frequency
|
64.0%
16/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Urinary Frequency
|
68.0%
17/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Urinary Incontinence
|
16.0%
4/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Urinary Incontinence
|
32.0%
8/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Urinary Retention
|
32.0%
8/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Urinary Retention
|
28.0%
7/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Urinary Tract Pain
|
12.0%
3/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Urinary Tract Pain
|
16.0%
4/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Urinary Tract Obstruction
|
32.0%
8/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Urinary Tract Obstruction
|
28.0%
7/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Acute - Urinary Urgency
|
36.0%
9/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Renal and urinary disorders
Late - Urinary Urgency
|
40.0%
10/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Reproductive system and breast disorders
Acute - Erectile Dysfunction
|
40.0%
10/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Reproductive system and breast disorders
Late - Erectile Dysfunction
|
60.0%
15/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Reproductive system and breast disorders
Acute - Prostatic Pain
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Reproductive system and breast disorders
Late - Prostatic Pain
|
4.0%
1/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Reproductive system and breast disorders
Acute - Testicular Disorder
|
12.0%
3/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
|
Reproductive system and breast disorders
Late - Testicular Disorder
|
12.0%
3/25 • GI and GU adverse events (AEs) & any grade ≥3 AE that is at least possibly related to radiation were tracked from start of treatment through data cut-off (median 416 days, full range 199-848 days). All serious AEs were collected. All cause mortality was collected from start of treatment through data cut-off (median 416 days, full range 199-848 days).
Acute AEs are defined as occurring within 90 days of treatment start. Late AEs are defined as those occurring 91 days through 5 years from treatment start. Future analysis plan: GI and GU AEs \& any grade ≥3 AE that is at least possibly related to radiation will be tracked from start of treatment through 5 years after discontinuation of treatment. All serious AEs will be collected. All cause mortality will be collected from start of treatment up to 5 years after discontinuation of treatment.
|
Additional Information
Amit Bhatt, MD, PhD
Washington University School of Medicine
Phone: 314-747-7236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place