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Androgen Receptor Partial Agonist
Flutamide for Prostate Cancer
Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-9 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
time to DNA double strand break
Side effects data
From 2011 Phase 4 trial • 115 Patients • NCT0061192338%
headache
31%
stomach pain
23%
dry skin
15%
insomnia
15%
hot flushes
15%
nausea
15%
Diarrhea
8%
fatigue
8%
dry mouth
8%
leg pain
8%
parasthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Flutamide
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?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,896 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,324 Patients Enrolled for Prostate Cancer
Daniel Song, M.D.Principal InvestigatorSKCCC at Johns Hopkins
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer diagnosis was confirmed through a tissue examination.I have a tumor that can be felt and biopsied.I have severe liver problems.My biopsy shows a Gleason score of 7 or higher.I have chosen brachytherapy and hormone therapy for my prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: flutamide
- Group 2: placebo
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the extent of patient involvement in this medical experiment?
"Affirmative. Clinicaltrials.gov reveals that this experiment, which was originally listed on May 10th 2019, is actively seeking participants. A total of 24 people must be selected from 2 separate facilities."
Answered by AI
Who is a plausible candidate for participation in this medical experiment?
"For consideration into this trial, individuals must have a diagnosis of prostate cancer and be aged 18 to 100. There is currently space for 24 participants in the study."
Answered by AI
Does this research endeavor still accept volunteers?
"Affirmative. Per clinicaltrials.gov, this medical research is currently enrolling participants with the first posting on May 10th 2019 and latest update on October 25th 2022. The study seeks 24 individuals from 2 different locations to participate in the trial."
Answered by AI
Is geriatric enrollment allowed in this trial?
"The age parameters for eligibility in this trial are 18 to 100 respectively."
Answered by AI
Has there been prior research conducted on Flutamide?
"Presently, 16 trials are being conducted to research Flutamide. 8 of those investigations have reached Phase 3 and the majority is concentrated in Decatur, Georgia with a total of 2372 clinical sites across the nation."
Answered by AI
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