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High Dose Testosterone Treatment for People with Metastatic Prostate Cancer and an ATM, CDK12 or CHEK2 Mutation

Clinicaltrials.gov identifier:
NCT05011383

Treatment
People who have metastatic castration-resistant prostate cancer with an ATM, CDK12, or CHEK2 mutation

Study Contact Information:

For additional information, please contact:  

Principal Investigator: Robert B Montgomery, MD, (206) 277-6878, Email: rbmontgo@uw.edu or 
Elahe Mostaghel, MD, (206) 762-1010, Email: emostagh@fhcrc.org

High Dose Testosterone Treatment for People with Metastatic Prostate Cancer and an ATM, CDK12 or CHEK2 Mutation

About the Study

This study will examine how well an increased dose of testosterone treatment works for people with castration-resistant cancer (mCRPC) with an , CDK12, or genetic mutation. Participants will continue to receive the medication as long as their cancer doesn’t get worse and they do not experience severe side effects.

Side effects and vital signs will be recorded to examine the safety and tolerability of the therapy. Participants will receive a bone scan, , and blood test to determine if the cancer is advancing.

What the Study Involves

Participants will get a shot with an elevated dose of testosterone once a month as long as their cancer doesn’t get worse and they do not experience severe side effects. They will receive a bone scan, , and regularly to measure the effectiveness of the medication.

Lead Researcher

Robert B Montgomery, MD, (206) 277-6878, Email: rbmontgo@uw.edu

Colorado

City: Aurora RECRUITING
Facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
Contact Info:
Daniel.Bowles@va.gov 720-723-6498

Connecticut

City: West Haven RECRUITING
Facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Contact Info:
Herta.Chao@va.gov 203-937-3421

Florida

City: Gainesville RECRUITING
Facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
Contact Info:
Jess.Delaune@va.gov 352-988-7504

City: Orlando RECRUITING
Facility: Orlando VA Medical Center, Orlando, FL
Contact Info:
Priya.Gopalan@va.gov 407-631-2389

Georgia

City: Decatur RECRUITING
Facility: Atlanta VA Medical and Rehab Center, Decatur, GA
Contact Info:
Maria.Ribeiro@va.gov 404-728-7680

Kentucky

City: Louisville RECRUITING
Facility: Robley Rex VA Medical Center, Louisville, KY
Contact Info:
502-287-3515

Missouri

City: Kansas City RECRUITING
Facility: Kansas City VA Medical Center, Kansas City, MO
Contact Info:
Linda.Verkruyse@va.gov 817-681-7115

City: Saint Louis RECRUITING
Facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
Contact Info:
Eric.Knoche@va.gov 314-289-6305

North Carolina

City: Durham RECRUITING
Facility: Durham VA Medical Center, Durham, NC
Contact Info:
Rhonda.Bitting@va.gov 919-286-0411

City: Salisbury RECRUITING
Facility: Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Contact Info:
704-638-9000

Oregon

City: Portland RECRUITING
Facility: VA Portland Health Care System, Portland, OR
Contact Info:
Julie.Graff@va.gov 503-220-8262

South Carolina

City: Charleston RECRUITING
Facility: Ralph H. Johnson VA Medical Center, Charleston, SC
Contact Info:
Stephen.Savage@va.gov 843-792-4531

Tennessee

City: Memphis RECRUITING
Facility: Memphis VA Medical Center, Memphis, TN
Contact Info:
901-523-8990

City: Nashville RECRUITING
Facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Contact Info:
615-873-6979

Washington

City: Seattle RECRUITING
Facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
Contact Info:
rbmontgo@uw.edu 206-277-6878
Robert B. Montgomery, MD

Wisconsin

City: Madison RECRUITING
Facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
Contact Info:
David.Kosoff@va.gov 608-256-1901

This Study is Open To:

Male assigned at birth, aged 18 years and older, who meet the following criteria:

  • Veterans who can receive care within the VA medical system.
  • Diagnosed with ,
  • Ongoing treatment that lowers the levels of male hormones produced by the testicles, which includes medications like gonadotropin-releasing hormone (GnRH) analogues or antagonists, or surgical removal of the testicles (orchiectomy)
  • Have a genetic mutation in , CDK12, or gene
  • Do not have severe symptoms related to your cancer
  • Your cancer has progressed after using one of the newer hormone therapies for cancer, such as , , apalutamide, darolutamide, etc.
This Study is Not Open To:

People under the age of 18 who:

  • Are currently receiving active therapy
  • Have small cell lung cancer
  • Have cancer that spread to the brain or liver
  • Have viral hepatitis or chronic liver disease
  • Have significant heart disease
  • Have pain related to their cancer and are using opioids, such as oxycodone, hydrocodone (Vicodin), morphine, methadone or fentanyl
  • Require a catheter to urinate
  • Have dementia or a mental disorder that will limit your ability to participate in the study