High Dose Testosterone Treatment for People with Metastatic Prostate Cancer and an ATM, CDK12 or CHEK2 Mutation
https://www.facingourrisk.org/research-clinical-trials/study/294/high-dose-testosterone-treatment-for-people-with-metastatic-prostate-cancer-and-an-atm-cdk12-or-chek2mutation
Clinicaltrials.gov identifier:
NCT05011383 (https://clinicaltrials.gov/show/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
About the Study
This study will examine how well an increased dose of testosterone treatment works for people with metastatic castration-resistant prostate cancer (mCRPC) with an ATM, CDK12, or CHEK2 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, CT 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, CT scan, and PSA regularly to measure the effectiveness of the medication.
Lead Researcher
Robert B Montgomery, MD, (206) 277-6878, Email: rbmontgo@uw.edu
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 metastatic, castration-resistant prostate cancer
- 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 ATM, CDK12, or CHEK2 gene
- Do not have severe symptoms related to your cancer
- Your prostate cancer has progressed after using one of the newer hormone therapies for prostate cancer, such as abiraterone, enzalutamide, 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
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.