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.
Study Type
OBSERVATIONAL
Enrollment
315
Chemotherapy will start 4-8 weeks after the completion of radiotherapy. The chemotherapy regimen will consist of docetaxel 75 mg/m² administered intravenously on Day 1, repeated every 21 days for a total of 4-6 cycles. In cases of significant neuroendocrine differentiation and if well-tolerated, a combination of docetaxel and carboplatin (docetaxel 75 mg/m² and carboplatin AUC 4-6) will be used. Pre-treatment with dexamethasone will be administered to reduce potential side effects.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGHebei Yi Zhou Cancer Hospital
Baoding, Hebei, China
RECRUITINGFailure-Free Survivall,FFS
The time from radiotherapy to the first occurrence of any of the following events: biochemical recurrence, systemic treatment modification due to confirmed consecutive PSA elevation, radiographic distant metastasis, or death from any cause, whichever occurred first.
Time frame: 5 years
Biochemical relapse-free survival,BRFS
The time from radiotherapy to the first occurrence of biochemical relapse (defined as PSA rise meeting the criteria for biochemical recurrence)
Time frame: 5 years
Metastasis-free survival, MFS
The time from radiotherapy to the first occurrence of distant metastasis.
Time frame: 5 years
Overall survival, OS
The time from radiotherapy to the first occurrence of death.
Time frame: 5 years
Toxicities
The assessment of adverse events will be conducted using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: 5 years
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