Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy With Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients With High-Risk Localized Prostate Cancer (Stage III and IV)"
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 134
- 主要终点
- Percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy
研究概览
简要总结
A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.
详细描述
Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy with Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) Primary Objective: To determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.
Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Histological confirmation of adenocarcinoma of the prostate.
- •Age > 18 years.
- •Localized high-risk prostate cancer, defined as:
- •Stage III: T3 N0 M0, Gleason grade 8, 9, or 10, or
- •Stage IV: T4 N0 M0, any Gleason grade or Tx N1 M0, any Gleason grade
- •PSA > 20 ng/mL.
- •Karnofsky index ≥ 70%
- •Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm
- •Absence of hepatic abnormality, with bilirubin values < 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site.
- •Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
- •Having given informed consent in writing.
排除标准
- •Previous hormone treatment during more than 3 months.
- •Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
- •Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
- •Metabolic disease or uncontrolled systemic disease.
- •Previous history of grade III-IV neuropathy (NCI CTCAE v3).
- •Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
- •Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
- •Inflammatory bowel disease.
研究组 & 干预措施
Docetaxel, hormone and radiation therapy
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
干预措施: Docetaxel (Drug)
Docetaxel, hormone and radiation therapy
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
干预措施: Hormone and radiation therapy (Biological)
Docetaxel, hormone and radiation therapy
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
干预措施: Radiation therapy (Radiation)
Hormone and radiation therapy
Radiation therapy and hormone therapy
干预措施: Hormone and radiation therapy (Biological)
Hormone and radiation therapy
Radiation therapy and hormone therapy
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy
时间窗: 5 years of randomization
Percentage of patients free of elevation of PSA by 2 ng/mL above the minimum level reached since treatment (biochemical reccurrence), calculating the at-call event, i.e., the date of last confirmatory test (Phoenix criteria).
次要结局
- Percentage of patients with biochemical recurrence-free survival(5 years)
- Percentage of patients with progression-free survival(5 years)
- Percentage of patients with overall survival.(5 years)
- Clinical response rate(5 years)
- Biochemical response rate.(5 years)
- Quality of life of the patients(screening and week 9)
- Safety profile of the treatment.(5 years)