Targeted Treatment for Metastatic Prostate Cancer: The PREDICT Trial
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT06632977
This clinical trial is exploring whether genetic testing can help decide the best treatment for patients with metastatic prostate cancer. The study involves using different medications based on the genetic makeup of the cancer to see if this approach can slow or stop the cancer from growing.
Patient Parameters
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Program Overview
The PREDICT trial is a phase II study that aims to determine if genetic testing can guide treatment decisions for patients with metastatic prostate cancer. By analyzing DNA and RNA from previous cancer tissue samples, researchers hope to assign patients to specific treatments that target their cancer's unique genetic features. The study includes various medications that work in different ways to slow or stop cancer growth, such as blocking certain proteins, hormones, or delivering targeted radiation to cancer cells.
Description
The main goals of the study are to see how well the treatments work in shrinking tumors and to monitor their safety. Patients will be assigned to one of three treatment groups based on their genetic test results.
- Group A: Patients take valemetostat tosylate daily, which targets specific proteins in cancer cells.
- Group B: Patients receive carboplatin and cabazitaxel through an IV, which work by killing or slowing the growth of cancer cells.
- Group C: Patients may receive one of several treatments, including cabazitaxel, abiraterone acetate with prednisone, enzalutamide, or a radiopharmaceutical called Lutetium Lu 177 vipivotide tetraxetan, depending on their specific cancer characteristics.
Throughout the trial, patients will undergo regular scans and tests to monitor their cancer's response to treatment. After completing the study treatment, patients will continue to be monitored for up to five years to track their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of prostate cancer, including certain rare types.
- Must have cancer that can be measured or has spread to other parts of the body.
- Must have tissue samples available from a previous biopsy or surgery.
- Must have undergone genetic testing as part of standard care.
- Must be 18 years or older.
- Must have progressive metastatic castration-resistant prostate cancer (mCRPC).
- Must have received certain prior treatments, including androgen receptor signaling inhibitors and taxane therapy, unless ineligible.
- Must have resolved any side effects from previous cancer treatments to a manageable level.
- Must not have had certain treatments or surgeries within a specified time before joining the study.
- Must meet specific health criteria, including blood counts and organ function.
- Must agree to follow study procedures and attend follow-up appointments.
Exclusion Criteria
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
| Medical Oncology Hematology Consultants PA | 19713 | Newark | Delaware |
| Mount Sinai Hospital | 10029 | New York | New York |
| University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
| West Virginia University Charleston Division | 25304 | Charleston | West Virginia |
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