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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexMale
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• High dose testosterone (Drug): High dose testosterone is administered subcutaneously once monthly until progression or toxicity

Non Randomized · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• CT scans: Part of the study plan
• bone scan: Part of the study plan

Main goals

• PSA response (12 weeks)

Planned enrollment: 51 (estimated).

• Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut
• North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida
• Orlando VA Medical Center, Orlando, FL, Orlando, Florida
• Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia
• Robley Rex VA Medical Center, Louisville, KY, Louisville, Kentucky
• Kansas City VA Medical Center, Kansas City, MO, Kansas City, Missouri
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis, Missouri
• Durham VA Medical Center, Durham, NC, Durham, North Carolina
• Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury, North Carolina
• VA Portland Health Care System, Portland, OR, Portland, Oregon
• Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina
• Memphis VA Medical Center, Memphis, TN, Memphis, Tennessee
• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee
• VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington
• William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison, Wisconsin

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05011383

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 16, 2026. Public record; not medical advice.