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High Dose Testosterone for Prostate Cancer with Specific Gene Changes

This study is testing high dose testosterone for men with metastatic prostate cancer (cancer that has spread). Researchers want to see if this treatment works well for men whose tumors have specific changes in their ATM, CDK12, or CHEK2 genes. These gene changes are related to how cells repair DNA. You would receive high dose testosterone as a shot under your skin once a month. The study will measure if your PSA (prostate-specific antigen) levels respond to the treatment after 12 weeks. The study is currently unclear on its recruitment status and plans to enroll 51 participants.

Study design
This is an unblinded, three-group study (meaning you and your doctors will know you are receiving the treatment) that will include 51 participants.
What's involved
You would receive high dose testosterone shots once a month until your disease gets worse or you experience side effects. You would also have frequent safety checks, including recording side effects, vital signs, and blood tests.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05011383

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers

Recruiting
PHASE2Ages 18+InterventionalTreatment
VA Office of Research and Development
~51 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:High dose testosterone

At a glance

Recruiting sites
16 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PSA response
Measured over 12 weeks

Conditions

Metastatic Prostate Cancer

Explore related trials

Prostate CarcinomaATM GeneCDK12 GeneSerine/Threonine-Protein Kinase Chk2

Where it's being run

17 sites across 13 states
Florida2
Missouri2
North Carolina2
Tennessee2
Colorado1
Connecticut1
Georgia1
Kentucky1

Study leadership

  • Robert B. Montgomery, MD · PRINCIPAL_INVESTIGATOR · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Who to contact

Robert B Montgomery, MD
[email protected]
(206) 277-6878
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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
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

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.

What this trial measures

  • PSA response12 weeks

    PSA response as measured by a 50% decline from baseline maintained for 12 weeks