High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency
VA Office of Research and Development
Summary
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
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 b…
Interventions
- DrugHigh dose testosterone
High dose testosterone is administered subcutaneously once monthly until progression or toxicity
Locations (17)
- Rocky Mountain Regional VA Medical Center, Aurora, COAurora, Colorado
- VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, Connecticut
- North Florida/South Georgia Veterans Health System, Gainesville, FLGainesville, Florida
- Orlando VA Medical Center, Orlando, FLOrlando, Florida
- Atlanta VA Medical and Rehab Center, Decatur, GADecatur, Georgia
- Robley Rex VA Medical Center, Louisville, KYLouisville, Kentucky