High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers (VA-BAT)

July 7, 2025 updated by: VA Office of Research and Development

High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency

This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an unblinded, three cohort phase II study evaluating the efficacy of high dose testosterone (BAT) for patients with mCRPC and inactivating mutations in ATM, CDK12 or CHEK2. Patients will receive BAT until disease progression or intolerance, whichever occurs first. Throughout the study, safety and tolerability will be assessed by frequent recording of adverse events, vital signs and safety laboratory assessments. Progression will be evaluated with bone scan, CT of the abdomen/pelvis and PSA as per PCWG3 criteria.

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Robert B Montgomery, MD
  • Phone Number: (206) 277-6878
  • Email: rbmontgo@uw.edu

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • Recruiting
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • North Florida/South Georgia Veterans Health System, Gainesville, FL
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Orlando VA Medical Center, Orlando, FL
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical and Rehab Center, Decatur, GA
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40206-1433
        • Recruiting
        • Robley Rex VA Medical Center, Louisville, KY
        • Contact:
          • Fred Hendler, MD
          • Phone Number: 502-287-3515
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Recruiting
        • Kansas City VA Medical Center, Kansas City, MO
        • Contact:
      • Saint Louis, Missouri, United States, 63106
        • Recruiting
        • St. Louis VA Medical Center John Cochran Division, St. Louis, MO
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham VA Medical Center, Durham, NC
        • Contact:
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
        • Contact:
          • Michael Goodman, MD
          • Phone Number: 15038 704-638-9000
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • VA Portland Health Care System, Portland, OR
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Recruiting
        • Ralph H. Johnson VA Medical Center, Charleston, SC
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38104-2127
        • Recruiting
        • Memphis VA Medical Center, Memphis, TN
        • Contact:
          • Alva Weir, MD
          • Phone Number: 6853 901-523-8990
      • Nashville, Tennessee, United States, 37212-2637
        • Recruiting
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
        • Contact:
          • Sally York, MD
          • Phone Number: 615-873-6979
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • Recruiting
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
        • Contact:
          • Robert B Montgomery, MD
          • Phone Number: 206-277-6878
          • Email: rbmontgo@uw.edu
        • Principal Investigator:
          • Robert B. Montgomery, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2254
        • Recruiting
        • William S. Middleton Memorial Veterans Hospital, Madison, WI
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
  • Male age > 18 years
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy

  • 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 (Response Evaluation Criteria in Solid Tumors)
    • 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.

Exclusion Criteria:

  • Currently receiving active therapy for other neoplastic disorders will not be eligible.
  • Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendrocrine differentiation without morphologic evidence is not exclusionary)
  • Known parenchymal brain metastasis
  • Liver metastases
  • 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).
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of <35 % at baseline
  • Patients with pain attributable to their prostate cancer and requiring the use of opioids.
  • Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll.
  • Presence of dementia, psychiatric illness, and/or social situations limiting compliance with study requirements or understanding and/or giving of informed consent.
  • Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATM
Patients with castration resistant prostate cancer which contains ATM alterations are treated with high dose testosterone
Drug: High dose testosterone
High dose testosterone is administered subcutaneously once monthly until progression or toxicity
Other Names:
  • Bipolar androgen therapy
Experimental: CDK12
Patients with castration resistant prostate cancer which contains CDK12 alterations are treated with high dose testosterone
Drug: High dose testosterone
High dose testosterone is administered subcutaneously once monthly until progression or toxicity
Other Names:
  • Bipolar androgen therapy
Experimental: CHEK2
Patients with castration resistant prostate cancer which contains CHEK2 alterations are treated with high dose testosterone
Drug: High dose testosterone
High dose testosterone is administered subcutaneously once monthly until progression or toxicity
Other Names:
  • Bipolar androgen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA response
Time Frame: 12 weeks
PSA response as measured by a 50% decline from baseline maintained for 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Robert B. Montgomery, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLP-003-20F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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