High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Start Date
8/31/2021
Completion Date
8/31/2027
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
Detailed 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 Criteria
Age Range: 18 years to No maximum
Interventions
High dose testosterone
Conditions
Locations
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado 80045
United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut 06516-2770
United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida 32608
United States
Orlando VA Medical Center, Orlando, FL
Orlando, Florida 32803
United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia 30033
United States
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky 40206-1433
United States
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri 64128
United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri 63106
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina 27705
United States
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina 28144
United States
VA Portland Health Care System, Portland, OR
Portland, Oregon 97239
United States
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina 29401-5799
United States
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee 38104-2127
United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee 37212-2637
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas 77030
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington 98108-1532
United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin 53705-2254
United States