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

Early Phase 1

Active, not recruiting

• 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
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 24

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
DNA double strand break formations	Post Flutimide 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, as compared to control patients receiving placebo. Extent of Gamma H2Ax as a measure of DNA double strand break formation.

Trial Locations

Locations (1)

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