Evaluating Docetaxel Chemotherapy After Radiotherapy for High-Grade Localized Prostate Cancer in Men Aged 18 to 80 Assessing Survival and Treatment Effects with Standard Radical Therapy

What this Trial Is About

Researchers are studying the effects of adding docetaxel chemotherapy after standard radical treatment in men with localized high-grade prostate cancer, specifically those with a Gleason score of 9-10 or containing a Gleason 5 component, without distant metastasis. The goal is to understand if this additional chemotherapy improves survival outcomes compared to standard treatment alone. The study includes men aged 18 to 80 with good performance status and adequate blood counts. Participants will be divided into two groups one receiving only standard radical treatment such as radiotherapy or surgery, possibly combined with endocrine therapy according to guidelines, and the other receiving the same standard treatment followed by four to six cycles of docetaxel chemotherapy given intravenously every 21 days starting 4 to 8 weeks after radiotherapy. In some cases with certain tumor features, docetaxel may be combined with carboplatin. Dexamethasone is given before chemotherapy to help reduce side effects. During the trial, participants will be monitored over five years to assess failure-free survival as the primary outcome, along with biochemical relapse-free survival, metastasis-free survival, overall survival, and treatment toxicities. Researchers will collect data through regular follow-ups to evaluate how well patients do after treatment and to track any adverse events. The study aims to provide clearer information about the benefits and risks of adding chemotherapy after radical treatment in this group of prostate cancer patients.

Adjuvant Chemotherapy for High Malignant Prostate Cancer