๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-21

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers (NCT05011383)

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

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: VA Office of Research and Development

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Rocky Mountain Regional VA Medical Center, Aurora, CO โ€” Aurora, Colorado

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (17 Sites)

  • Rocky Mountain Regional VA Medical Center, Aurora, CO โ€” Aurora, Colorado
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT โ€” West Haven, Connecticut
  • North Florida/South Georgia Veterans Health System, Gainesville, FL โ€” Gainesville, Florida
  • Orlando VA Medical Center, Orlando, FL โ€” Orlando, Florida
  • Atlanta VA Medical and Rehab Center, Decatur, GA โ€” Decatur, Georgia
  • Robley Rex VA Medical Center, Louisville, KY โ€” Louisville, Kentucky
  • Kansas City VA Medical Center, Kansas City, MO โ€” Kansas City, Missouri
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO โ€” St Louis, Missouri
  • Durham VA Medical Center, Durham, NC โ€” Durham, North Carolina
  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC โ€” Salisbury, North Carolina
  • VA Portland Health Care System, Portland, OR โ€” Portland, Oregon
  • Ralph H. Johnson VA Medical Center, Charleston, SC โ€” Charleston, South Carolina
  • Memphis VA Medical Center, Memphis, TN โ€” Memphis, Tennessee
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN โ€” Nashville, Tennessee
  • Michael E. DeBakey VA Medical Center, Houston, TX โ€” Houston, Texas
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA โ€” Seattle, Washington
  • William S. Middleton Memorial Veterans Hospital, Madison, WI โ€” Madison, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (206) 277-6878

Email: Robert.Montgomery@va.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—