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Androgen Receptor Partial Agonist

Flutamide for Prostate Cancer

Phase < 1
Waitlist Available
Led By Daniel Song, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suitable volume of disease for biopsy: clinically palpable disease corresponding to (ipsilateral to) any involved core on biopsy
Histologically confirmed prostate cancer
Must not have
Severe hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post flutimide exposure up to 12 hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial will test if flutamide can help treat prostate cancer by creating double strand breaks in the DNA of cancer cells.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Flutamide may cause side effects like liver problems, digestive disturbances, allergic reactions, and other potential complications which will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be felt and biopsied.
Select...
My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
My biopsy shows a Gleason score of 7 or higher.
Select...
I have chosen brachytherapy and hormone therapy for my prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe liver problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post flutimide exposure up to 12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and post flutimide exposure up to 12 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
DNA double strand break formations

Side effects data

From 2011 Phase 4 trial • 115 Patients • NCT00611923
38%
headache
31%
stomach pain
23%
dry skin
15%
nausea
15%
hot flushes
15%
insomnia
15%
Diarrhea
8%
fatigue
8%
leg pain
8%
parasthesia
8%
dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Flutamide

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: flutamideExperimental Treatment1 Intervention
50mg flutamide prior to brachytherapy and prostatic biopsy
Group II: placeboPlacebo Group1 Intervention
placebo prior to brachytherapy and prostatic biopsy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flutamide
FDA approved

Find a Location

Who is running the clinical trial?

Patrick C. Walsh FundUNKNOWN
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,206 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,404 Patients Enrolled for Prostate Cancer
Daniel Song, M.D.Principal InvestigatorSKCCC at Johns Hopkins
1 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

Flutamide (Androgen Receptor Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03507608 — Phase < 1
Prostate Cancer Research Study Groups: flutamide, placebo
Prostate Cancer Clinical Trial 2023: Flutamide Highlights & Side Effects. Trial Name: NCT03507608 — Phase < 1
Flutamide (Androgen Receptor Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03507608 — Phase < 1
~4 spots leftby Nov 2025
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