Trial Outcomes & Findings for Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression (NCT NCT03507608)
NCT ID: NCT03507608
Last Updated: 2025-10-16
Results Overview
To confirm DNA double-strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed. A value less than 1 indicates a decrease and a value greater than 1 indicates an increase.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Post Flutamide exposure up to 12 hours
Results posted on
2025-10-16
Participant Flow
All participants in the run-in phase received flutamide. In the second phase, additional participants were randomized, double-blind phase to receive "Flutamide" or "Placebo
Participant milestones
| Measure |
Flutamide Run In
Single-arm run-in phase: patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (\>1 patients with DSBs on biopsy), then accrual will continue in the randomized, double-blind phase 2.
|
Phase 2: DB Flutamide
Flutamide: 50mg flutamide prior to brachytherapy and prostatic biopsy
|
Phase 2: DB Placebo
Placebo: placebo prior to brachytherapy and prostatic biopsy
|
|---|---|---|---|
|
Period 1: Single-arm run-in Phase
STARTED
|
6
|
0
|
0
|
|
Period 1: Single-arm run-in Phase
COMPLETED
|
6
|
0
|
0
|
|
Period 1: Single-arm run-in Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2: Randomized, Double-blind Phase
STARTED
|
0
|
14
|
5
|
|
Period 2: Randomized, Double-blind Phase
COMPLETED
|
0
|
14
|
5
|
|
Period 2: Randomized, Double-blind Phase
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Run-In
n=6 Participants
6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention.
Patients within the run-in phase will receive 250mg prior to brachytherapy and prostatic biopsy
|
Flutamide
n=14 Participants
250mg flutamide prior to brachytherapy and prostatic biopsy
Flutamide: 250mg flutamide prior to brachytherapy and prostatic biopsy
|
Placebo
n=5 Participants
placebo prior to brachytherapy and prostatic biopsy
Placebo: placebo prior to brachytherapy and prostatic biopsy
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex/Gender, Customized
Male Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=14 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
14 Participants
n=14 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=25 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=6 Participants
|
6 Participants
n=14 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=6 Participants
|
8 Participants
n=14 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=25 Participants
|
|
Age, Continuous
|
66 years
n=6 Participants
|
65.86 years
n=14 Participants
|
60.20 years
n=5 Participants
|
64.76 years
n=25 Participants
|
PRIMARY outcome
Timeframe: Post Flutamide exposure up to 12 hoursPopulation: Patients with tumor tissue at biopsy. Patients that received Flutamide in Phase 2.
To confirm DNA double-strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed. A value less than 1 indicates a decrease and a value greater than 1 indicates an increase.
Outcome measures
| Measure |
Flutamide
n=12 Participants
50mg flutamide prior to brachytherapy and prostatic biopsy
Flutamide: 50mg flutamide prior to brachytherapy and prostatic biopsy
|
Placebo
placebo prior to brachytherapy and prostatic biopsy
Placebo: placebo prior to brachytherapy and prostatic biopsy
|
|---|---|---|
|
Fold-change Post Flutamide Exposure
|
5.860 Fold-change
Interval 0.868 to 8.852
|
—
|
Adverse Events
Flutamide Run In
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flutamide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flutamide Run In
n=6 participants at risk
Single-arm run-in phase: patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (\>1 patients with DSBs on biopsy), then accrual will continue in the randomized, double-blind phase 2.
|
Flutamide
n=14 participants at risk
50mg flutamide prior to brachytherapy and prostatic biopsy
Flutamide: 50mg flutamide prior to brachytherapy and prostatic biopsy
|
Placebo
n=5 participants at risk
Placebo prior to brachytherapy and prostatic biopsy
Placebo: placebo prior to brachytherapy and prostatic biopsy
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/6 • From enrollment up to 6 months
|
0.00%
0/14 • From enrollment up to 6 months
|
20.0%
1/5 • Number of events 1 • From enrollment up to 6 months
|
Additional Information
Dana Kaplin
Johns Hopkins SOM, Dept of Radiation Oncology
Phone: 443-690-7007
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place