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

Early Phase 1CompletedNCT03507608

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

FlutamideDRUG

50mg flutamide prior to brachytherapy and prostatic biopsy

PlaceboOTHER

placebo prior to brachytherapy and prostatic biopsy

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

SKCCC at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Fold-change Post Flutamide Exposure

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.

Time frame: Post Flutamide exposure up to 12 hours

Data from ClinicalTrials.gov

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