Adding Docetaxel Chemotherapy to Hormonal Therapy and Apalutamide for Men with Metastatic Castrate-Sensitive Prostate Cancer Phase 3 Randomized Trial

What this Trial Is About

Researchers are evaluating the effect of adding docetaxel chemotherapy to the usual hormonal therapy and apalutamide treatment for men with prostate cancer that has spread to other parts of the body. This phase III trial focuses on metastatic castrate-sensitive prostate cancer and aims to see if the combination improves overall survival and other important outcomes compared to hormonal therapy and apalutamide alone. The study also explores genetic factors, disease progression, symptoms, quality of life, and imaging correlations to better understand treatment impact. Participants are randomly assigned to one of two groups. One group receives androgen deprivation therapy ADT and apalutamide taken orally daily on a 12-week cycle unless disease progresses or side effects occur. The other group receives the same ADT and apalutamide treatment plus docetaxel given intravenously every 21 days for up to six doses. Throughout the study, participants undergo CT or MRI scans and bone scans, with optional PSMA PET scans and blood sample collections to monitor disease status. During the trial, participants complete questionnaires about symptoms and quality of life. Researchers assess overall survival, radiographic progression, time to castration-resistant prostate cancer, skeletal event-free survival, and treatment safety for up to 10 years after randomization. Additional measures include PSA response, disease progression, and genetic markers. Follow-up visits occur every six months after treatment completion, supporting long-term monitoring and safety evaluation.

Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial