Trial Outcomes & Findings for Radiation and Androgen Ablation for Prostate Cancer (NCT NCT01517451)
NCT ID: NCT01517451
Last Updated: 2026-02-11
Results Overview
To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.
COMPLETED
PHASE1/PHASE2
45 participants
From consent up to 5 years post treatment completion
2026-02-11
Participant Flow
Participant milestones
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
Radiation Therapy: 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Androgen Deprivation Therapy (ADT): Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
Radiation Therapy: 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Androgen Deprivation Therapy (ADT): Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=44 Participants
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
Radiation Therapy: 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Androgen Deprivation Therapy (ADT): Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=44 Participants
|
|
Age, Continuous
|
65 Years
n=44 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: From consent up to 5 years post treatment completionTo assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.
Outcome measures
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=44 Participants
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).
|
0 progression events
|
SECONDARY outcome
Timeframe: Consent to up to 5 years of follow-up or biochemical failure.Incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.
Outcome measures
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=45 Participants
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events
GU
|
4 events
|
|
Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events
GI
|
0 events
|
SECONDARY outcome
Timeframe: Start of treatment up to 5 yearsAssess clinical control rate by measuring the Overall Survival (OS) which is defined as the percentage of participants who completed the study that lived from time of treatment until death from any cause.
Outcome measures
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=44 Participants
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Overall Survival Rate
|
44 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years post treatmentBiomarker studies. Number of patients who completed blood collection of whole blood for future research.
Outcome measures
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=44 Participants
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Number of Patients Who Completed Blood Collection of Whole Blood for Future Research
|
10 Participants
|
SECONDARY outcome
Timeframe: Measured at baseline and at 3, 12, 24 and 36 months post treatmentPopulation: Patients with data collected
The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for Benign prostatic hyperplasia (BPH) patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of Lower Urinary Tract Symptoms (LUTS) and quality of life. Patients can fill out the IPSS form before examinations, but minimal interference from health care providers must be ensured. Total score range 0-35; A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic.
Outcome measures
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=44 Participants
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).
Baseline
|
7.32 score on a scale
Standard Deviation 5.49
|
|
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).
3 month Follow-up
|
7.79 score on a scale
Standard Deviation 5.77
|
|
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).
12 month Follow-up
|
7.91 score on a scale
Standard Deviation 5.66
|
|
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).
24 month Follow-up
|
2.00 score on a scale
Standard Deviation NA
Only one patient completed the IPSS assessment therefore a standard deviation cannot be calculated.
|
|
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).
36 month Follow-up
|
6.82 score on a scale
Standard Deviation 4.88
|
SECONDARY outcome
Timeframe: Baseline and at 3,12, 24 and 36 months follow-upPopulation: Patients with data collected
The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction (ED). Total score range 5 to 25; higher scores indicate better erectile function. A total score of 21 or less indicates erectile dysfunction. 22-25: No erectile dysfunction, 17-21: Mild ED, 12-16: Mild-to-moderate ED, 8-11: Moderate ED, 5-7: Severe ED.
Outcome measures
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=44 Participants
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment
Baseline SHIM
|
15.3 score on a scale
Standard Deviation 8.96
|
|
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment
3 months
|
6.14 score on a scale
Standard Deviation 8.99
|
|
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment
12 months
|
7.16 score on a scale
Standard Deviation 8.66
|
|
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment
24 months
|
25.0 score on a scale
Standard Deviation NA
\[1\] NA Explanation: Only one patient completed the SHIM assessment therefore a standard deviation cannot be calculated.
|
|
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment
36 months
|
6.79 score on a scale
Standard Deviation 8.08
|
SECONDARY outcome
Timeframe: 3,12, 24 and 36 months follow-upPopulation: At each timepoint the number of participants varies based on patient data collected for the EPIC assessment.
The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring sexual health related quality of life. Scores range from 1 to 100, with higher scores being better score.
Outcome measures
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=44 Participants
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health
3 months
|
34.7 score on a scale
Standard Deviation 46.5
|
|
The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health
12 months
|
38.2 score on a scale
Standard Deviation 34.3
|
|
The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health
24 months
|
100 score on a scale
Standard Deviation NA
\[1\] NA Explanation: Only one patient completed the EPIC assessment therefore a standard deviation cannot be calculated.
|
|
The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health
36 months
|
39.8 score on a scale
Standard Deviation 27.6
|
Adverse Events
Radiation With Androgen Deprivation Therapy (ADT)
Serious adverse events
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=45 participants at risk
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Infections and infestations
Skin Infection
|
2.2%
1/45 • Number of events 1 • From enrollment up to 5 years
|
|
Nervous system disorders
Syncope
|
2.2%
1/45 • From enrollment up to 5 years
|
Other adverse events
| Measure |
Radiation With Androgen Deprivation Therapy (ADT)
n=45 participants at risk
Patients receiving combined regimen of radiation therapy 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy).
|
|---|---|
|
Reproductive system and breast disorders
Erectile disfunction
|
8.9%
4/45 • Number of events 4 • From enrollment up to 5 years
|
Additional Information
Dr. Daniel Song
Johns Hopkins Department of Radiation Oncology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place