Study on Checkpoint Inhibitors for Men with Advanced Prostate Cancer with Specific Genetic Changes
Sponsor: VA Office of Research and Development
ClinicalTrials ID:NCT04104893
This clinical trial is testing the effectiveness of the drug pembrolizumab in men with advanced prostate cancer that has specific genetic changes. The study aims to see how well the drug works and how safe it is for these patients.
Patient Parameters
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Program Overview
The main goal of this study is to see if pembrolizumab, a type of immunotherapy, can help treat men with advanced prostate cancer that has spread and is resistant to standard hormone treatments. The cancer must have specific genetic changes, either a mismatch repair deficiency or changes in the CDK12 gene. Researchers will also look at how often these genetic changes occur in patients and how pembrolizumab affects various health outcomes, such as cancer progression and overall survival. The study will also compare tumor samples taken before and after treatment to understand why some tumors respond to pembrolizumab and others do not.
Description
This study is for men with advanced prostate cancer that has spread and is resistant to hormone therapy. The cancer must have specific genetic changes, either a mismatch repair deficiency or changes in the CDK12 gene. Participants will receive the drug pembrolizumab every three weeks. The study will monitor how well the drug works and its safety.
Participants will undergo genetic testing to confirm the presence of the required genetic changes. If eligible, they will receive pembrolizumab and continue hormone therapy to keep testosterone levels low. Tumor samples will be taken before and after treatment to study the effects of pembrolizumab. The study aims to find out if pembrolizumab can help control the cancer and improve survival.
The study is important because prostate cancer is a leading cause of cancer death in men, and new treatments are needed for those who do not respond to current therapies. Pembrolizumab has shown promise in treating other types of cancer, and this study will help determine if it can benefit men with advanced prostate cancer with specific genetic changes.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must provide written consent to participate.
- Must have a diagnosis of prostate cancer that has spread.
- Cancer must be resistant to hormone therapy, with low testosterone levels.
- Must have received prior treatment with certain hormone therapies.
- Must have specific genetic changes in the cancer.
- Must have adequate organ function and blood counts.
- Must agree to use contraception during and after the study.
Exclusion Criteria
- Cannot have brain metastases.
- Cannot have received certain prior treatments for prostate cancer.
- Cannot have active infections or require antibiotics.
- Cannot have a history of severe lung inflammation.
- Cannot have active hepatitis B or C, or HIV.
- Cannot have received a live vaccine recently.
- Cannot have severe allergies to pembrolizumab.
- Cannot have psychiatric or substance abuse issues that interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | 94121 | San Francisco | California |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | 90073-1003 | West Los Angeles | California |
| Washington DC VA Medical Center, Washington, DC | 20422-0001 | Washington | District of Columbia |
| Bay Pines VA Healthcare System, Pay Pines, FL | 33744 | Bay Pines | Florida |
| Jesse Brown VA Medical Center, Chicago, IL | 60612 | Chicago | Illinois |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | 48105 | Ann Arbor | Michigan |
| James J. Peters VA Medical Center, Bronx, NY | 10468 | Bronx | New York |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | 10010 | New York | New York |
| Durham VA Medical Center, Durham, NC | 27705 | Durham | North Carolina |
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | 19104 | Philadelphia | Pennsylvania |
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