Trial Outcomes & Findings for Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial (NCT NCT01411332)
NCT ID: NCT01411332
Last Updated: 2023-05-22
Results Overview
Number of participants showing positive prostate biopsy finding post treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Up to 2.25 years
Results posted on
2023-05-22
Participant Flow
Only 9 participants in Arm I and 7 participants in Arm II received study intervention.
Participant milestones
| Measure |
Arm I: SIMRT
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
All participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of a total of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Enrollment
STARTED
|
9
|
9
|
|
Enrollment
COMPLETED
|
9
|
7
|
|
Enrollment
NOT COMPLETED
|
0
|
2
|
|
Treatment
STARTED
|
9
|
7
|
|
Treatment
COMPLETED
|
8
|
7
|
|
Treatment
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm I: SIMRT
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
All participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of a total of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Enrollment
Protocol Violation
|
0
|
1
|
|
Enrollment
Withdrawal by Subject
|
0
|
1
|
|
Treatment
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial
Baseline characteristics by cohort
| Measure |
Arm I: SIMRT
n=9 Participants
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=9 Participants
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 2.25 yearsPopulation: Of the 18 enrolled participants, only 16 participants were still enrolled at the 2.25 years follow up. Of the 16 participants, only 9 participants were able to complete the post treatment biopsy.
Number of participants showing positive prostate biopsy finding post treatment.
Outcome measures
| Measure |
Arm I: SIMRT
n=4 Participants
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=5 Participants
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Number of Participants With Biopsy Failure
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Only 16 participants received study intervention.
Toxicity rate will be reported as the number of participants experiencing any treatment-related adverse events. Acute and Late Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Acute toxicity will be defined as any treatment-related adverse event during and within 3 months of completing treatment. Late Toxicity will be defined as any treatment-related adverse events occurring more than 3 months after treatment completion.
Outcome measures
| Measure |
Arm I: SIMRT
n=9 Participants
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=7 Participants
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Toxicity Rate
Treatment-related Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Treatment-related Acute Toxicity (<=3 months of completing treatment)
|
9 Participants
|
7 Participants
|
|
Toxicity Rate
Treatment-related Grade 3 or higher Acute Toxicity
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Treatment-related Late Toxicity (>3 months after completing treatment)
|
7 Participants
|
5 Participants
|
|
Toxicity Rate
Treatment-related Grade 3 or higher Late Toxicity
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Only 16 participants received study intervention.
Mortality will be reported as overall survival and failure free survival. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. Failure free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.
Outcome measures
| Measure |
Arm I: SIMRT
n=9 Participants
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=7 Participants
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Mortality
Failure Free Survival
|
64.9 months
Interval 64.8 to 65.6
|
65.0 months
Interval 64.1 to 65.6
|
|
Mortality
Overall Survival
|
64.9 months
Interval 64.8 to 65.6
|
65.0 months
Interval 64.1 to 65.6
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Only 16 participants received study intervention.
Failure rate will be reported as the incidence of biochemical or clinical failure. Biochemical failure is defined is an increase of 2 or greater from nadir of Prostate Specific Antigen (PSA) levels. Clinical Failure is defined as newly identified extension outside the prostate after initial regression, or urinary obstructive symptoms with carcinoma or regional/distant failure due to radiographic evidence metastasis.
Outcome measures
| Measure |
Arm I: SIMRT
n=9 Participants
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=7 Participants
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Failure Rate
Biochemical Failure
|
0 Participants
|
0 Participants
|
|
Failure Rate
Clinical Failure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks).Population: Only 16 participants received study intervention. Not all participants completed the survey at all time points.
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Outcome measures
| Measure |
Arm I: SIMRT
n=9 Participants
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=7 Participants
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
EPIC SF-12 Scores
Urinary Function (Incontinence): Baseline (Prior to treatment)
|
90.8 score on a scale
Standard Deviation 14.2
|
89.3 score on a scale
Standard Deviation 15.7
|
|
EPIC SF-12 Scores
Urinary Function (Incontinence): Last week of treatment (Up to 8 weeks)
|
82.2 score on a scale
Standard Deviation 23.9
|
84.8 score on a scale
Standard Deviation 27.1
|
|
EPIC SF-12 Scores
Urinary Function (Incontinence): 6 weeks after treatment (Up to 14 weeks)
|
87.3 score on a scale
Standard Deviation 14.0
|
82.1 score on a scale
Standard Deviation 24.5
|
|
EPIC SF-12 Scores
Urinary Function (Incontinence): 3 months after treatment (Up to 20 weeks)
|
93.8 score on a scale
Standard Deviation 10.8
|
93.2 score on a scale
Standard Deviation 12.8
|
|
EPIC SF-12 Scores
Urinary Function (Incontinence): 9 months after treatment (Up to 44 weeks)
|
88.8 score on a scale
Standard Deviation 12.0
|
83.8 score on a scale
Standard Deviation 15.2
|
|
EPIC SF-12 Scores
Urinary Symptoms (Irritative/Obstructive): Baseline (Prior to treatment)
|
92.1 score on a scale
Standard Deviation 5
|
82.1 score on a scale
Standard Deviation 19.5
|
|
EPIC SF-12 Scores
Urinary Symptoms (Irritative/Obstructive): Last week of treatment (Up to 8 weeks)
|
81.1 score on a scale
Standard Deviation 17.6
|
73.6 score on a scale
Standard Deviation 25.6
|
|
EPIC SF-12 Scores
Urinary Symptoms (Irritative/Obstructive): 6 weeks after treatment (Up to 14 weeks)
|
91.5 score on a scale
Standard Deviation 7.9
|
82.1 score on a scale
Standard Deviation 22.9
|
|
EPIC SF-12 Scores
Urinary Irritative/Obstructive: 3 months after treatment (Up to 20 weeks)
|
93.3 score on a scale
Standard Deviation 12
|
89.3 score on a scale
Standard Deviation 12.4
|
|
EPIC SF-12 Scores
Urinary Irritative/Obstructive: 9 months after treatment (Up to 44 weeks)
|
95.6 score on a scale
Standard Deviation 5.6
|
79 score on a scale
Standard Deviation 16
|
|
EPIC SF-12 Scores
Bowel Habits: Baseline (Prior to treatment)
|
94.3 score on a scale
Standard Deviation 6.3
|
88.7 score on a scale
Standard Deviation 15.9
|
|
EPIC SF-12 Scores
Bowel Habits: Last week of treatment (Up to 8 weeks)
|
90.3 score on a scale
Standard Deviation 13.7
|
92.3 score on a scale
Standard Deviation 5.6
|
|
EPIC SF-12 Scores
Bowel Habits: 6 weeks after treatment (Up to 14 weeks)
|
98.4 score on a scale
Standard Deviation 2.2
|
94 score on a scale
Standard Deviation 6.7
|
|
EPIC SF-12 Scores
Bowel Habits: 3 months after treatment (Up to 20 weeks)
|
95.8 score on a scale
Standard Deviation 7.5
|
96.4 score on a scale
Standard Deviation 4.5
|
|
EPIC SF-12 Scores
Bowel Habits: 9 months after treatment (Up to 44 weeks)
|
93.8 score on a scale
Standard Deviation 8
|
86.5 score on a scale
Standard Deviation 9.2
|
|
EPIC SF-12 Scores
Sexual Function: Baseline (Prior to treatment)
|
49.4 score on a scale
Standard Deviation 29.2
|
37.5 score on a scale
Standard Deviation 32.7
|
|
EPIC SF-12 Scores
Sexual Function: Last week of treatment (Up to 8 weeks)
|
41.5 score on a scale
Standard Deviation 29.6
|
35.9 score on a scale
Standard Deviation 30.1
|
|
EPIC SF-12 Scores
Sexual Function: 6 weeks after treatment (Up to 14 weeks)
|
43.8 score on a scale
Standard Deviation 27.3
|
33.6 score on a scale
Standard Deviation 31.2
|
|
EPIC SF-12 Scores
Sexual Function: 3 months after treatment (Up to 20 weeks)
|
35.1 score on a scale
Standard Deviation 22.1
|
40.3 score on a scale
Standard Deviation 37.9
|
|
EPIC SF-12 Scores
Sexual Function: 9 months after treatment (Up to 44 weeks)
|
28 score on a scale
Standard Deviation 14.9
|
44.8 score on a scale
Standard Deviation 40
|
|
EPIC SF-12 Scores
Hormonal Function: Baseline (Prior to treatment)
|
88.8 score on a scale
Standard Deviation 11.9
|
77.9 score on a scale
Standard Deviation 25.3
|
|
EPIC SF-12 Scores
Hormonal Function: Last week of treatment (Up to 8 weeks)
|
90 score on a scale
Standard Deviation 10.9
|
79.3 score on a scale
Standard Deviation 25.6
|
|
EPIC SF-12 Scores
Hormonal Function: 6 weeks after treatment (Up to 14 weeks)
|
84.4 score on a scale
Standard Deviation 14.9
|
71.4 score on a scale
Standard Deviation 18.2
|
|
EPIC SF-12 Scores
Hormonal Function: 3 months after treatment (Up to 20 weeks)
|
89.4 score on a scale
Standard Deviation 16.8
|
79.3 score on a scale
Standard Deviation 16.4
|
|
EPIC SF-12 Scores
Hormonal Function: 9 months after treatment (Up to 44 weeks)
|
91.9 score on a scale
Standard Deviation 11.3
|
83 score on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks)Population: Only 16 participants received study intervention. Not all participants completed the survey at all time points.
Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
Arm I: SIMRT
n=9 Participants
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=7 Participants
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
MAX-PC Scores
Baseline (Prior to treatment)
|
10.6 score on a scale
Standard Deviation 9.0
|
16.6 score on a scale
Standard Deviation 9.2
|
|
MAX-PC Scores
Last week of treatment (Up to 8 weeks)
|
12.3 score on a scale
Standard Deviation 7.7
|
13.9 score on a scale
Standard Deviation 7.9
|
|
MAX-PC Scores
6 weeks after treatment (Up to 14 weeks)
|
12.9 score on a scale
Standard Deviation 3.3
|
13.0 score on a scale
Standard Deviation 8.1
|
|
MAX-PC Scores
3 months after treatment (Up to 20 weeks)
|
10.6 score on a scale
Standard Deviation 5.0
|
11.3 score on a scale
Standard Deviation 3.5
|
|
MAX-PC Scores
9 months after treatment (Up to 44 weeks)
|
10.0 score on a scale
Standard Deviation 6.8
|
9.6 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: While tissue was collected for biomarker, none of the samples were analyzed because of insufficient patient numbers and power to draw conclusions. These types of analyses are done in batches and we never reached an appropriate threshold of cases to perform even exploratory analyses. No samples have been analyzed for biomarkers using IHC.
The amount of biomarker expression will be evaluated via immunohistochemistry (IHC) from ultrasound guided prostate biopsy tissue samples for both functional MRI suspicious regions and those that are not suspicious.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: While blood was collected for cfDNA assessment, none of the samples were analyzed because of insufficient patient numbers and power to draw conclusions. These types of analyses are done in batches and we never reached an appropriate threshold of cases to perform even exploratory analyses. No samples have been analyzed for cfDNA.
Incidence of circulating free DNA, as assessed from blood samples.
Outcome measures
Outcome data not reported
Adverse Events
Arm I: SIMRT
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm II: HTIMRT
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm I: SIMRT
n=9 participants at risk
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=7 participants at risk
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Hematuria
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
Other adverse events
| Measure |
Arm I: SIMRT
n=9 participants at risk
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
|
Arm II: HTIMRT
n=7 participants at risk
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Gastrointestinal disorders
Anal hemorrhage
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 3 • Up to 6 years
|
28.6%
2/7 • Number of events 2 • Up to 6 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
88.9%
8/9 • Number of events 15 • Up to 6 years
|
85.7%
6/7 • Number of events 6 • Up to 6 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 2 • Up to 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
77.8%
7/9 • Number of events 15 • Up to 6 years
|
28.6%
2/7 • Number of events 4 • Up to 6 years
|
|
General disorders
Edema Limbs
|
11.1%
1/9 • Number of events 2 • Up to 6 years
|
57.1%
4/7 • Number of events 4 • Up to 6 years
|
|
Reproductive system and breast disorders
Ejaculation Disorder
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
42.9%
3/7 • Number of events 3 • Up to 6 years
|
|
Endocrine disorders
Low Testosterone
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
44.4%
4/9 • Number of events 4 • Up to 6 years
|
42.9%
3/7 • Number of events 6 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
22.2%
2/9 • Number of events 3 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 5 • Up to 6 years
|
85.7%
6/7 • Number of events 9 • Up to 6 years
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/9 • Up to 6 years
|
28.6%
2/7 • Number of events 3 • Up to 6 years
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Blood on Rectum
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Gastrointestinal disorders
Hard Stool
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Hematuria
|
22.2%
2/9 • Number of events 4 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Vascular disorders
Hot Flashes
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Investigations
Low Testosterone
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Libido decreased
|
22.2%
2/9 • Number of events 2 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Papulopustular rash
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Reproductive system and breast disorders
Penile Pain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Gastrointestinal disorders
Proctitis
|
11.1%
1/9 • Number of events 2 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Rectal Pain
|
22.2%
2/9 • Number of events 2 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Renal and urinary disorders
Renal and Urinary Disorder - Other
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Reproductive system and breast disorders
Low Testosterone
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Reproductive system and breast disorders
Testicular Disorder
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Testicular Pain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 2 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Frequency
|
77.8%
7/9 • Number of events 19 • Up to 6 years
|
100.0%
7/7 • Number of events 10 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
66.7%
6/9 • Number of events 11 • Up to 6 years
|
42.9%
3/7 • Number of events 5 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Retention
|
44.4%
4/9 • Number of events 8 • Up to 6 years
|
42.9%
3/7 • Number of events 6 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
22.2%
2/9 • Number of events 2 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Urinary Urgency
|
100.0%
9/9 • Number of events 21 • Up to 6 years
|
85.7%
6/7 • Number of events 12 • Up to 6 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Bloating
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Blood and lymphatic system disorders
Polycitemia
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Cardiac disorders
Chest Pain - Cardiac
|
11.1%
1/9 • Number of events 2 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Investigations
Creatinine Increased
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Dizziness
|
33.3%
3/9 • Number of events 6 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Ear and labyrinth disorders
Ear Pain
|
22.2%
2/9 • Number of events 2 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
22.2%
2/9 • Number of events 2 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
General disorders
Fever
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 2 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/9 • Up to 6 years
|
28.6%
2/7 • Number of events 2 • Up to 6 years
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 2 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Irritated Seborrheic Keratosis
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
General disorders
Pain
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Penile Infection
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma in SITU Bowens Disease
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Skin Infection
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
28.6%
2/7 • Number of events 2 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Investigations
Weight gain
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
14.3%
1/7 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
11.1%
1/9 • Number of events 1 • Up to 6 years
|
0.00%
0/7 • Up to 6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place