Prostate Cancer > Flutamide

Flutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen By Daniel Song, M.D.

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Approved in 4 jurisdictions

Trial Summary

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.

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

I have a tumor that can be felt and biopsied.

My prostate cancer diagnosis was confirmed through a tissue examination.

My biopsy shows a Gleason score of 7 or higher.

I have chosen brachytherapy and hormone therapy for my prostate cancer.

Exclusion Criteria

I have severe liver problems.

Participant Groups

The study is testing if a single dose of the drug flutamide can cause double strand breaks in DNA within prostate cancer cells during standard treatment. It's compared against a placebo in men already receiving hormone therapy and brachytherapy.

Group I: flutamide Experimental Treatment 1 Intervention

50mg flutamide prior to brachytherapy and prostatic biopsy

Group II: placebo Placebo Group 1 Intervention

placebo prior to brachytherapy and prostatic biopsy

Flutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Eulexin for:

• Prostate cancer

🇪🇺 Approved in European Union as Flutamide for:

• Prostate cancer

🇨🇦 Approved in Canada as Flutamide for:

• Prostate cancer

🇯🇵 Approved in Japan as Flutamide for:

• Prostate cancer

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Johns Hopkins Baltimore, MD

SKCCC at Johns Hopkins Baltimore, MD

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lead Sponsor

Patrick C. Walsh Fund Collaborator

References