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Hormone Therapy

High Dose Testosterone for Prostate Cancer (VA-BAT Trial)

Phase 2
Recruiting
Led By Robert B. Montgomery, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and one of the following: PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart, Evaluable disease progression by modified RECIST 1.1, Progression of metastatic bone disease on bone scan with > 2 new lesions, Presence of metastatic disease on bone or CT scan, Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.), Asymptomatic or minimal cancer related symptoms, Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2, Presence of inactivating mutations in ATM, CDK12 or CHEK2 as determined by a CLIA level assay for DNA sequencing
Histologically or cytologically confirmed adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

VA-BAT Trial Summary

This trial will test whether intermittent high-dose testosterone therapy can shrink tumors in men with DNA repair deficiency.

Who is the study for?
This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy. They must be on androgen deprivation treatment, have specific gene mutations (ATM, CDK12, CHEK2), and an ECOG Performance Status <2. Excluded are those with dementia, other cancers being treated, liver metastases or significant heart disease.Check my eligibility
What is being tested?
The study tests if high dose testosterone can benefit patients whose prostate cancer has DNA repair deficiencies due to ATM, CDK12 or CHEK2 alterations. It's a prospective study checking the hypothesis that genetically unstable tumors respond well to this treatment.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of high dose testosterone may include acne, sleep apnea, enlarged breasts, testicular shrinkage and increased risk of certain cardiovascular events.

VA-BAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer was confirmed by a lab test.
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I am on hormone therapy for cancer or have had surgery to remove my testicles.
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I am a man older than 18.

VA-BAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PSA response

Awards & Highlights

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.

VA-BAT Trial Design

3Treatment groups
Experimental Treatment
Group I: CHEK2Experimental Treatment1 Intervention
Patients with castration resistant prostate cancer which contains CHEK2 alterations are treated with high dose testosterone
Group II: CDK12Experimental Treatment1 Intervention
Patients with castration resistant prostate cancer which contains CDK12 alterations are treated with high dose testosterone
Group III: ATMExperimental Treatment1 Intervention
Patients with castration resistant prostate cancer which contains ATM alterations are treated with high dose testosterone

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,599 Previous Clinical Trials
3,305,047 Total Patients Enrolled
15 Trials studying Prostate Cancer
8,785 Patients Enrolled for Prostate Cancer
Robert B. Montgomery, MDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
3 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Prostate Cancer
14 Patients Enrolled for Prostate Cancer

Media Library

High dose testosterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05011383 — Phase 2
Prostate Cancer Research Study Groups: CHEK2, ATM, CDK12
Prostate Cancer Clinical Trial 2023: High dose testosterone Highlights & Side Effects. Trial Name: NCT05011383 — Phase 2
High dose testosterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011383 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
VA Puget Sound Health Care System Seattle Division, Seattle, WA
What portion of applicants met pre-screening criteria?
Met criteria
~25 spots leftby Aug 2026