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High Dose Testosterone for Prostate Cancer (VA-BAT Trial)
VA-BAT Trial Summary
This trial will test whether intermittent high-dose testosterone therapy can shrink tumors in men with DNA repair deficiency.
VA-BAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVA-BAT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VA-BAT Trial Design
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Who is running the clinical trial?
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- I am a man older than 18.I do not have active hepatitis or severe liver disease.My prostate cancer was confirmed by a lab test.I have brain metastases.My cancer has spread to my liver.I need opioids to manage my prostate cancer pain.I need a catheter to urinate due to my cancer.I am on hormone therapy for cancer or have had surgery to remove my testicles.I have serious heart issues, including a recent heart attack or severe angina.My cancer diagnosis was confirmed through tissue examination.
- Group 1: CHEK2
- Group 2: ATM
- Group 3: CDK12
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many people can join this clinical trial at most?
"In order to move forward with this research, 51 willing and eligible patients are required. Qualified individuals can enroll at Orlando VA Medical Center in Orlando, Florida or Central Alabama Veterans Health Care System West Campus located in Montgomery, Alabama."
Do many different hospitals have this trial available to their patients?
"There are a total of 14 locations for this trial, which include the Orlando VA Medical Center in Orlando, FL, Central Alabama Veterans Health Care System West Campus in Montgomery, AL and North Florida/South Georgia Veterans Health System in Gainesville."
Are we still able to sign up for this experiment?
"That is correct. The clinical trial, which was posted on August 31st 2021 and edited September 1st 2022, is actively looking for 51 patients from 14 different locations according to information found on clinicaltrials.gov"
Are there any other similar studies that have been conducted with High dose testosterone?
"High dose testosterone was first studied in the year 2004 at USC/Norris Comprehensive Cancer Center and Hospital. Since then, a total of 189 completed trials have been conducted. The number of ongoing studies is currently 32, with a large concentration of these being based out of Orlando, Florida."
For what purpose is high dose testosterone therapy most often indicated?
"High doses of testosterone are most often used to treat hypogonadotropic hypogonadism in men. However, it can also help with other conditions such as 1 to 5 years post-menopausal, orchidectomy, orchitis."
What does the FDA have to say about high doses of testosterone?
"While there is some data suggesting that high doses of testosterone are safe, as this is only a phase 2 trial, there is no compelling evidence yet of the efficacy of this treatment."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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