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
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
High dose testosterone is administered subcutaneously once monthly until progression or toxicity
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
PSA response
PSA response as measured by a 50% decline from baseline maintained for 12 weeks
Time frame: 12 weeks
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VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
RECRUITINGNorth Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
RECRUITINGOrlando VA Medical Center, Orlando, FL
Orlando, Florida, United States
RECRUITINGAtlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
RECRUITINGRobley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, United States
RECRUITINGKansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States
RECRUITINGSt. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States
RECRUITINGDurham VA Medical Center, Durham, NC
Durham, North Carolina, United States
RECRUITINGSalisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States
RECRUITING...and 7 more locations