Flutamide for Prostate Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Flutamide for prostate cancer?
Research shows that flutamide is effective in treating advanced prostate cancer, with response rates similar to traditional hormone therapy and improvements in symptoms and quality of life. Additionally, combining flutamide with other treatments like Zoladex can lead to quicker relief of symptoms, although it may also increase side effects.12345
Is flutamide safe for humans?
How does the drug flutamide differ from other treatments for prostate cancer?
Flutamide is a non-steroidal anti-androgen that works by blocking the action of male hormones (androgens) which can fuel the growth of prostate cancer. Unlike some other treatments, it can be used in combination with an LHRH agonist to enhance effectiveness, and it generally does not affect libido or sexual potency.123910
What is the purpose of this trial?
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.
Research Team
Daniel Song, M.D.
Principal Investigator
SKCCC at Johns Hopkins
Eligibility Criteria
Men with prostate cancer who've chosen brachytherapy and androgen suppression as treatments can join. They need to have a certain amount of detectable disease for biopsy, confirmed by tests, including at least one biopsy core with Gleason 7 or higher. Participants must sign a consent form. Those with severe liver issues, allergies to flutamide, or major illnesses that could affect treatment aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Initial 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention with 50mg flutamide prior to brachytherapy and prostatic biopsy
Randomized Treatment
Randomized, double-blind phase with patients receiving either 50mg flutamide or placebo prior to brachytherapy and prostatic biopsy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Flutamide
Flutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Prostate cancer
- Prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Patrick C. Walsh Fund
Collaborator