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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
Male age > 18 years
Must not have
Active or symptomatic viral hepatitis or chronic liver disease AST or ALT > 2.5 x ULN or total bilirubin > ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia)
Known parenchymal brain metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man older than 18.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active hepatitis or severe liver disease.
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I have brain metastases.
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My cancer has spread to my liver.
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I need opioids to manage my prostate cancer pain.
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I have serious heart issues, including a recent heart attack or severe angina.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PSA response

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
1,668 Previous Clinical Trials
3,765,815 Total Patients Enrolled
16 Trials studying Prostate Cancer
8,979 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
~17 spots leftby Aug 2026
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