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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03507608

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

25

Starts

2019-05-10

Expected to finish

2025-07-03

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• SKCCC at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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