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

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Androgens; Flutamide

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.