Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
试验速览
- 阶段
- 3 期
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).
研究概览
简要总结
The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).
The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total sample size estimated at 252 patients, with a two-sided type I error rate of 5% (non-parametric methods.
详细描述
Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in phase III trials (1-2). It is likely to demonstrate a substantial role in the management of early-stage PC patients in the neoadjuvant and adjuvant settings, where clinical trials are underway.•53% of all men who undergo radical prostatectomy will develop prostate-specific antigen (PSA) elevations in the 10 years following surgery, with approximately 77% of these recurrences occurring within the first 2 years.A prospective, multicenter, national, randomized, two-arm, phase III study comparing hormonal treatment (LH-RH agonist alone) with or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic prostate cancer patients at high risk of systemic recurrence after initial treatment (radical prostatectomy or radiotherapy).
- PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004
- TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically documented adenocarcinoma of the prostate
- •Previous treatment with either radical prostatectomy or radiation therapy
- •Salvage radiotherapy for local relapse allowed
- •Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA
- •Life expectancy of more than 12 months
- •Non metastatic disease documented by imaging including radionuclide bone scan
- •ECOG performance status 0-1
- •ANC > 1,500/mm3
- •Platelet counts > 100,000/mm3
- •SGOT and/or SGPT may be up to 2.5 x ULN
- •Patients at high risk of biological relapse defined by:
- •Gleason > 8
- •PSA-DT < 6 months
- •Positive surgical margins
- •PSA velocity > 0.75 ng/mL/year
- •Pathological pelvic lymph nodes involvement (pN+)
- •Time from initial treatment until inclusion < 12 months
排除标准
- •Prior chemotherapy by taxanes and estramustine phosphate
- •Documented local recurrence of prostate cancer or documented metastatic disease
- •History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin
- •Active infection
- •Significant cardiac disease, angina pectoris or myocardial infarction within twelve months
- •Clinically significant neuropathy
- •Medical condition requiring the use of concomitant corticosteroids
- •Prohibited concomitant therapy with experimental drug.
- •Participation in another clinical trial for the period < 30 days
研究组 & 干预措施
1
干预措施: Docetaxel + hormonal treatment (LH-RH agonist) (Drug)
2
干预措施: Hormonal treatment (LH-RH agonist) (Drug)
结局指标
主要结局
The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).
时间窗: Every month during 5 years.
次要结局
- Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL).(Every month during 5 years)