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.
Study Sites
Colorado
Aurora
Rocky Mountain Regional VA Medical Center
Contact: Daniel Bowles, MD 720-723-6498 Daniel.Bowles@va.gov
Connecticut
West Haven
VA Connecticut Healthcare System West Haven Campus
Contact: Herta Chao, MD 203-584-0902 Herta.Chao@va.gov
Florida
Gainsville
North Florida/South Georgia Veterans Health System
Contact: Jess D Delaune, MD 352-988-7504 Jess.Delaune@va.gov
Orlando
Orlando VA Medical Center
Contact: Priya K Gopalan, MD 407-631-2389 Priya.Gopalan@va.gov
Georgia
Decatur
Atlanta VA Medical and Rehab Center
Contact: Maria Ribeiro, MD 404-728-7680 Maria.Ribeiro@va.gov
Kentucky
Louisville
Robley Rex VA Medical Center
Contact: Fred Hendler, MD 502- 28-3515
Missouri
Kansas City
Kansas City VA Medical Center
Contact: Linda Verkruyse, MD 817-681-7115 Linda.Verkruyse@va.gov
Saint Louis
St. Louis VA Medical Center John Cochran Division
Contact: Eric Knoche, MD 314-289-6305 Eric.Knoche@va.gov
North Carolina
Durham
Durham VA Medical Center
Contact: Rhonda Bitting, MD 919-286-0411 ext 17-5441 Rhonda.Bitting@va.gov
Salisbury
Salisbury W.G. (Bill) Hefner VA Medical Center
Contact: Michael Goodman, MD 704-638-9000 ext. 15038
Oregon
Portland
VA Portland Health Care System
Contact: Julie Graff, MD 503-220-8262 Julie.Graff@va.gov
South Carolina
Charleston
Ralph H. Johnson VA Medical Center
Contact: Steven Savage, MD 843-792-4531 Stephen.Savage@va.gov
Tennessee
Memphis
Memphis VA Medical Center
Contact: Alva Weir, MD 901-523-8990 ext. 6853
Nashville
Tennessee Valley Healthcare System Nashville Campus
Contact: Sally York, MD 615-873-6979
Washington
Seattle
VA Puget Sound Health Care System Seattle Division
Contact: Robert B Montgomery, MD 206-277-6878 rbmontgo@uw.edu
Lead Researcher
Robert B Montgomery, MD, (206) 277-6878, Email: rbmontgo@uw.edu
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.
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