Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression

Early Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Flutamide; Other: Placebo

• Registration Number: NCT03507608
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.

Detailed Description

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating DSBs (double strand breaks) in prostate cancer within patients receiving central androgen suppression and brachytherapy. The initial phase is a 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. All 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. Subjects will be randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.

Study Timeline

• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-25
• Study Start: 2019-05-10
• Primary Completion: 2024-09-30
• Study Completion: 2025-07-03
• Results First Submitted: 2025-07-25
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Results First Posted: 2025-10-16
• Last Update Posted: 2025-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Histologically confirmed prostate cancer
• At least one biopsy core with Gleason 7 or higher disease
• The patient has decided to undergo brachytherapy plus androgen suppression as treatment modality for his prostate cancer (with or without supplemental external beam radiation)
• Suitable volume of disease for biopsy:
• clinically palpable disease corresponding to (ipsilateral to) any involved core on biopsy
• Signed study-specific consent form prior to registration

Exclusion Criteria

• Known hypersensitivity or allergic response to flutamide
• Severe hepatic impairment
• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flutamide	Flutamide	50mg flutamide prior to brachytherapy and prostatic biopsy
placebo	Placebo	placebo prior to brachytherapy and prostatic biopsy

Primary Outcome Measures

Name	Time	Method
Fold-change Post Flutamide Exposure	Post Flutamide exposure up to 12 hours	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.

Trial Locations

Locations (1)

SKCCC at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States