Personalized Treatment for Metastatic Castration-Resistant Prostate Cancer Using Genetic Testing and Targeted Therapies in a Phase 2 Study

What this Trial Is About

Researchers are evaluating targeted treatments for metastatic prostate cancer by using genetic testing to guide therapy choices. This phase II trial studies whether identifying DNA and RNA abnormalities in cancer tissue can help assign patients to specific treatments including valemetostat tosylate, carboplatin with cabazitaxel, or physician-chosen therapies such as cabazitaxel, abiraterone acetate with prednisone, enzalutamide, or lutetium Lu 177 vipivotide tetraxetan. The study aims to assess tumor response, safety, progression-free survival, overall survival, and patient-reported outcomes. Patients undergo genetic testing on previously collected tissue samples to determine their treatment group. In Arm A, patients receive valemetostat tosylate orally once daily in 28-day cycles. Arm B patients receive carboplatin and cabazitaxel intravenously every 21 days. Arm C patients receive one of several treatments chosen by their physician, including intravenous cabazitaxel every 21 days, oral abiraterone acetate with prednisone daily in 28-day cycles, oral enzalutamide daily in 28-day cycles, or lutetium Lu 177 vipivotide tetraxetan intravenously every 42 days for up to six cycles. Throughout treatment, patients have MRI, CT, and bone scans, with optional PET scans and blood collections. After treatment, patients without disease progression are followed every two months for six months, then every three months for up to five years those with progression are followed every six months for five years. Assessments include imaging, laboratory tests, and patient questionnaires to measure tumor response, progression, survival, symptomatic events, treatment tolerability, and quality of life. The trial monitors outcomes such as objective response within six months and longer-term survival up to five years.

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial