Trial Outcomes & Findings for Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy (NCT NCT03570827)

Results Overview

Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA \>= 0.5 ng/ml). The count and percentage of patient free from failure will be reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

5 years

Results posted on

2026-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Group I (Hypofractionated Radiation Therapy) Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.	Group II (Radiation Therapy, Androgen Suppression Therapy) Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.	Group III (Radiation Therapy, Androgen Suppression Therapy) Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
Overall Study STARTED	14	33	6
Overall Study COMPLETED	11	32	6
Overall Study NOT COMPLETED	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group I (Hypofractionated Radiation Therapy) Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.	Group II (Radiation Therapy, Androgen Suppression Therapy) Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.	Group III (Radiation Therapy, Androgen Suppression Therapy) Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
Overall Study Withdrawal by Subject	3	1	0

Baseline Characteristics

Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group I (Hypofractionated Radiation Therapy) n=11 Participants Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.	Group II (Radiation Therapy, Androgen Suppression Therapy) n=32 Participants Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.	Group III (Radiation Therapy, Androgen Suppression Therapy) n=6 Participants Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.	Total n=49 Participants Total of all reporting groups
Age, Continuous	67.243 years STANDARD_DEVIATION 6.972 • n=20 Participants	68.830 years STANDARD_DEVIATION 6.071 • n=32 Participants	70.824 years STANDARD_DEVIATION 5.778 • n=64 Participants	68.718 years STANDARD_DEVIATION 6.202 • n=50 Participants
Sex: Female, Male Female	0 Participants n=20 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants	0 Participants n=50 Participants
Sex: Female, Male Male	11 Participants n=20 Participants	32 Participants n=32 Participants	6 Participants n=64 Participants	49 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=20 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants	1 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=20 Participants	31 Participants n=32 Participants	6 Participants n=64 Participants	47 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	1 Participants n=32 Participants	0 Participants n=64 Participants	1 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	1 Participants n=32 Participants	0 Participants n=64 Participants	1 Participants n=50 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=20 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants	1 Participants n=50 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	1 Participants n=32 Participants	0 Participants n=64 Participants	1 Participants n=50 Participants
Race (NIH/OMB) White	9 Participants n=20 Participants	30 Participants n=32 Participants	6 Participants n=64 Participants	45 Participants n=50 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants	1 Participants n=50 Participants

PRIMARY outcome

Timeframe: 5 years

Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA \>= 0.5 ng/ml). The count and percentage of patient free from failure will be reported.

Outcome measures

Outcome measures
Measure	Group I (Hypofractionated Radiation Therapy) n=11 Participants Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.	Group II (Radiation Therapy, Androgen Suppression Therapy) n=32 Participants Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.	Group III (Radiation Therapy, Androgen Suppression Therapy) n=6 Participants Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
Freedom From Failure (FFF)	7 Participants	16 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Overall survival is defined as the time from enrollment until death due to any cause.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Biochemical failure is defined as a rise in prostate-specific antigen (PSA) levels after treatment, indicating that the cancer may be recurring or progressing.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will use clinical, biochemical and SAD as events. Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years following completion of radiation therapy

Will be assessed by the number of patients using salvage androgen deprivation use (SAD) at 5 years post radiation therapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years after completion of radiation therapy

Summation of relative scores for sexual function items (items 31 through 39) from the Expanded Prostate Cancer Index Composite (EPIC) instrument will be used to measure each individual's quality of life. The EPIC questionnaire is designed to measure Quality of Life issues in patients with Prostate Cancer. The questionnaire consists of 32 questions in 5 domains. Each question is answered on a 5-point scale such as 0-4 where 1=no problem and 4=big problem.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Summation of relative scores for quality of life items from the Expanded Prostate Cancer Index Composite (EPIC) instrument will be used to measure each individual's quality of life. The EPIC questionnaire is designed to measure Quality of Life issues in patients with Prostate Cancer. The questionnaire consists of 32 questions in 5 domains. Each question is answered on a 5-point scale such as 0-4 where 1=no problem and 4=big problem.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Distant metastasis is cancer that has spread from the original (primary) tumor location to distant organs or distant lymph nodes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Start of treatment assessed up to 5 years

Will be measured from the treatment start date to the date of documented local failure as determined either by clinical exam, imaging, or by prostate re-biopsy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Will be performed using NCI CTCAE v4 criteria. The maximum grade for each type of acute adverse events (AE) will be recorded for each patient.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria. The maximum grade for each type of acute adverse events (AE) will be recorded for each patient.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Correlated with outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

Group I (Hypofractionated Radiation Therapy)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 2 deaths

Group II (Radiation Therapy, Androgen Suppression Therapy)

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Group III (Radiation Therapy, Androgen Suppression Therapy)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Group I (Hypofractionated Radiation Therapy) n=14 participants at risk Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.	Group II (Radiation Therapy, Androgen Suppression Therapy) n=33 participants at risk Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.	Group III (Radiation Therapy, Androgen Suppression Therapy) n=6 participants at risk Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
Cardiac disorders Cardiac arrest	7.1% 1/14 • Number of events 1 • 5 years	0.00% 0/33 • 5 years	0.00% 0/6 • 5 years
General disorders Death NOS	7.1% 1/14 • Number of events 1 • 5 years	0.00% 0/33 • 5 years	16.7% 1/6 • Number of events 1 • 5 years

Other adverse events

Other adverse events
Measure	Group I (Hypofractionated Radiation Therapy) n=14 participants at risk Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.	Group II (Radiation Therapy, Androgen Suppression Therapy) n=33 participants at risk Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.	Group III (Radiation Therapy, Androgen Suppression Therapy) n=6 participants at risk Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
General disorders Fatigue	7.1% 1/14 • Number of events 1 • 5 years	0.00% 0/33 • 5 years	0.00% 0/6 • 5 years
General disorders Pain	35.7% 5/14 • Number of events 11 • 5 years	18.2% 6/33 • Number of events 9 • 5 years	0.00% 0/6 • 5 years
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/14 • 5 years	3.0% 1/33 • Number of events 1 • 5 years	0.00% 0/6 • 5 years
Nervous system disorders Encephalopathy	7.1% 1/14 • Number of events 1 • 5 years	0.00% 0/33 • 5 years	0.00% 0/6 • 5 years
Renal and urinary disorders Cystitis noninfective	7.1% 1/14 • Number of events 1 • 5 years	0.00% 0/33 • 5 years	0.00% 0/6 • 5 years
Renal and urinary disorders Hematuria	7.1% 1/14 • Number of events 2 • 5 years	3.0% 1/33 • Number of events 1 • 5 years	0.00% 0/6 • 5 years
Renal and urinary disorders Urinary frequency	71.4% 10/14 • Number of events 39 • 5 years	97.0% 32/33 • Number of events 141 • 5 years	100.0% 6/6 • Number of events 26 • 5 years
Renal and urinary disorders Urinary incontinence	50.0% 7/14 • Number of events 24 • 5 years	72.7% 24/33 • Number of events 91 • 5 years	50.0% 3/6 • Number of events 16 • 5 years
Renal and urinary disorders Urinary retention	35.7% 5/14 • Number of events 13 • 5 years	48.5% 16/33 • Number of events 40 • 5 years	83.3% 5/6 • Number of events 10 • 5 years
Renal and urinary disorders Urinary tract obstruction	14.3% 2/14 • Number of events 3 • 5 years	36.4% 12/33 • Number of events 24 • 5 years	33.3% 2/6 • Number of events 9 • 5 years
Renal and urinary disorders Urinary tract pain	0.00% 0/14 • 5 years	3.0% 1/33 • Number of events 1 • 5 years	0.00% 0/6 • 5 years
Renal and urinary disorders Urinary urgency	57.1% 8/14 • Number of events 26 • 5 years	81.8% 27/33 • Number of events 86 • 5 years	100.0% 6/6 • Number of events 20 • 5 years
Reproductive system and breast disorders Erectile dysfunction	42.9% 6/14 • Number of events 11 • 5 years	63.6% 21/33 • Number of events 46 • 5 years	100.0% 6/6 • Number of events 16 • 5 years
Gastrointestinal disorders Diarrhea	21.4% 3/14 • Number of events 3 • 5 years	12.1% 4/33 • Number of events 5 • 5 years	0.00% 0/6 • 5 years
Gastrointestinal disorders Fecal incontinence	0.00% 0/14 • 5 years	3.0% 1/33 • Number of events 1 • 5 years	0.00% 0/6 • 5 years
Gastrointestinal disorders Proctitis	7.1% 1/14 • Number of events 1 • 5 years	12.1% 4/33 • Number of events 5 • 5 years	0.00% 0/6 • 5 years
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/14 • 5 years	21.2% 7/33 • Number of events 10 • 5 years	16.7% 1/6 • Number of events 1 • 5 years

Additional Information

Carlos Vargas

Mayo Clinic

Phone: 480-342-6083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place