Prostate Cancer Clinical Trial
Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
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.
Full 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.
Eligibility Criteria
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.
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There is 1 Location for this study
Baltimore Maryland, 21287, United States More Info
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