RecruitingPhase 2NCT05011383

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

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

Sponsor

VA Office of Research and Development

Enrollment

51 participants

Start Date

Aug 31, 2021

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

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

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether high-dose testosterone can treat advanced prostate cancer in men whose tumors have specific genetic mutations — in the ATM, CDK12, or CHEK2 genes — and whose cancer has stopped responding to hormone-lowering therapy. **You may be eligible if...** - You are a male over 18 with confirmed prostate cancer - Your cancer has a confirmed mutation in ATM, CDK12, or CHEK2 genes - You are currently on hormone deprivation therapy (medication or surgery to lower testosterone) - Your cancer has progressed despite prior hormone treatments - Your overall health is good enough to tolerate treatment **You may NOT be eligible if...** - Your tumor does not have ATM, CDK12, or CHEK2 mutations - You have uncontrolled heart disease or high blood pressure - You have had a stroke or blood clot recently - You are on blood thinners that cannot be paused - You have widespread bone metastases causing significant symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05011383

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