Spots Global Cancer Trial Database for High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
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We do not endorse or review these studies in any way.
Trial Identification
Brief Title: High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Official Title: High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency
Study ID: NCT05011383
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida, United States
Orlando VA Medical Center, Orlando, FL, Orlando, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States
Robley Rex VA Medical Center, Louisville, KY, Louisville, Kentucky, United States
Kansas City VA Medical Center, Kansas City, MO, Kansas City, Missouri, United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO, Saint Louis, Missouri, United States
Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury, North Carolina, United States
VA Portland Health Care System, Portland, OR, Portland, Oregon, United States
Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, United States
Memphis VA Medical Center, Memphis, TN, Memphis, Tennessee, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, United States
Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington, United States
Contact Details
Name: Robert B. Montgomery, MD
Affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
Role: PRINCIPAL_INVESTIGATOR
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