High Dose Testosterone Treatment for Prostate Cancers with ATM, CDK12, or CHEK2 Gene Changes
Sponsor: VA Office of Research and Development
ClinicalTrials ID:NCT05011383
This study is exploring whether high doses of testosterone can help treat prostate cancers that have specific gene changes affecting DNA repair. The goal is to see if these gene changes make the cancer more likely to respond to this treatment.
Patient Parameters
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Program Overview
The study aims to find out if high doses of testosterone can effectively treat prostate cancers that have certain gene changes (ATM, CDK12, or CHEK2) which affect DNA repair. These changes might make the cancer more likely to respond to the treatment. The study will monitor the safety and effectiveness of this approach in patients with advanced prostate cancer.
Description
This study is testing high doses of testosterone (BAT) in patients with advanced prostate cancer that has specific gene changes (ATM, CDK12, or CHEK2). The treatment will continue until the cancer progresses or the patient cannot tolerate it. Throughout the study, doctors will closely monitor patients for any side effects and check the cancer's status using scans and blood tests. The study will help determine if this treatment can effectively manage prostate cancer with these genetic changes.
Eligibility Criteria
Inclusion Criteria
- Must be a male over 18 years old.
- Have a confirmed diagnosis of prostate cancer.
- Currently receiving hormone therapy to lower testosterone levels, unless the patient has had surgery to remove the testicles.
- Prostate cancer that continues to grow despite low testosterone levels, shown by rising PSA levels, tumor growth on scans, or new bone lesions.
- Have cancer that has spread to bones or other areas, visible on scans.
- Have tried at least one advanced hormone therapy drug without success.
- Have few or no symptoms from the cancer.
- Be in good general health, able to carry out daily activities with minimal restrictions.
- Have specific gene changes (ATM, CDK12, or CHEK2) confirmed by a lab test.
Exclusion Criteria
- Currently receiving treatment for another type of cancer.
- Have a type of prostate cancer called small cell carcinoma.
- Have cancer that has spread to the brain or liver.
- Have active liver disease or high liver enzyme levels.
- Have significant heart disease or recent heart attack.
- Require opioids for cancer-related pain.
- Have urinary blockage due to the tumor that requires a catheter.
- Have dementia or psychiatric conditions that affect understanding or following study requirements.
- Any other medical condition that the study doctors believe would make participation unsafe.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | 80045 | Aurora | Colorado |
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | 06516-2770 | West Haven | Connecticut |
| North Florida/South Georgia Veterans Health System, Gainesville, FL | 32608 | Gainesville | Florida |
| Orlando VA Medical Center, Orlando, FL | 32803 | Orlando | Florida |
| Atlanta VA Medical and Rehab Center, Decatur, GA | 30033 | Decatur | Georgia |
| Robley Rex VA Medical Center, Louisville, KY | 40206-1433 | Louisville | Kentucky |
| Kansas City VA Medical Center, Kansas City, MO | 64128 | Kansas City | Missouri |
| St. Louis VA Medical Center John Cochran Division, St. Louis, MO | 63106 | Saint Louis | Missouri |
| Durham VA Medical Center, Durham, NC | 27705 | Durham | North Carolina |
| Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC | 28144 | Salisbury | North Carolina |
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