High Dose Testosterone Treatment for People with Metastatic Prostate Cancer and an ATM, CDK12 or CHEK2 Mutation
Treatment
People who have metastatic castration-resistant prostate cancer with an ATM, CDK12, or CHEK2 mutation
Clinicaltrials.gov identifier:NCT05011383
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
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.
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
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
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
Locations:
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
Treatment
People who have metastatic castration-resistant prostate cancer with an ATM, CDK12, or CHEK2 mutation
Clinicaltrials.gov identifier:NCT05011383
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