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RECRUITING
NCT05011383
PHASE2

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Official title: High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2021-08-31

Completion Date

2027-08-31

Last Updated

2025-07-09

Healthy Volunteers

No

Interventions

DRUG

High dose testosterone

High dose testosterone is administered subcutaneously once monthly until progression or toxicity

Locations (17)

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

St 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

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States