Adjuvant Chemotherapy for High Malignant Prostate Cancer

This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.

NCT Number	NCT06864533
Lead Sponsor	Peking University First Hospital Collaborators: Peking University Shenzhen Hospital
Conditions	Prostate Cancer, Radiation Therapy, Chemotherapy, Gleason Score
Enrollment	315 participants
Start Date	2019-09-01
Primary Completion	2025-09-01 (estimated)
Study Completion	2031-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-06