OncoMatch/Clinical Trials/NCT05011383
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Is NCT05011383 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies High dose testosterone for metastatic prostate cancer.
Treatment: High dose testosterone — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: ATM inactivating mutation
Required: CDK12 inactivating mutation
Required: CHEK2 inactivating mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen receptor signaling inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide)
Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.).
Must have received: gonadotropin-releasing hormone analogue/antagonist or orchiectomy
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
Lab requirements
Liver function
AST or ALT ≤ 2.5 x ULN or total bilirubin ≤ ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia)
Cardiac function
No 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
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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