Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 3
- 主要终点
- Failure-Free Survivall，FFS
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components.
- •No evidence of distant metastasis confirmed by imaging.
- •Expected to receive standard radical treatment or postoperative radiotherapy.
- •Estimated survival time greater than 12 months.
- •Aged ≥ 18 years.
- •Karnofsky Performance Status (KPS) ≥
- •Adequate blood count: white blood cell ≥ 3.5 × 10^9/L, neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100.0 × 10^
排除标准
- •History of malignant tumors (except those cured for more than 5 years).
- •Previous abdominal radiation therapy.
- •Weight loss > 10% within the past 6 months.
- •Pre-existing or concomitant bleeding disorders.
- •Active infections.
- •Significant cardiovascular disease (e.g., controlled hypertension, unstable angina, NYHA class ≥ II congestive heart failure, unstable symptomatic arrhythmias, or ≥ II peripheral vascular disease) or any condition deemed intolerable to chemotherapy by the oncology department.
研究组 & 干预措施
Standard Treatment Group
This group will receive the standard radical treatment for high-grade localized prostate cancer. Patients will undergo definitive or post operative radiotherapy. Endocrine therapy will be provided for high-risk patients as per NCCN guidelines, with a duration of 2 to 3 years with definitive radiotherapy . For postoperative patients, endocrine therapy will be given for salvage setting.
Standard Treatment Plus Chemotherapy Group
This group will receive the standard radical treatment as in Arm 2, followed by adjuvant chemotherapy with docetaxel. 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.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Failure-Free Survivall，FFS
时间窗: 5 years
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.
次要结局
- Biochemical relapse-free survival，BRFS(5 years)
- Metastasis-free survival, MFS(5 years)
- Overall survival, OS(5 years)
- Toxicities(5 years)