EUCTR2005-002355-40-SE进行中（未招募）不适用
An open randomized phase III trial of six cycles of docetaxel versus surveillance after radical prostatectomy in prostate cancer patients with high grade pT3 or margin positive pT2 - AdPro
Scandinavian prostate cancer group0 个研究点目标入组 460 人开始时间: 2005年6月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •*Men > 18 and =70 years of age.
- •*WHO/ECOG performance status 0 – 1.
- •*Histologically proven adenocarcinoma of the prostate.
- •*Either of the following:
- •- pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical
- •prostatectomy specimen or
- •- pT3b tumours with Gleason score 4 or higher
- •- any pT3 tumour with Gleason score 4+3 or higher.
- •- any pT stage if histological proven lymph node metastasis and Gleason score 3+4
- •*If pre-operative PSA =10.0 ng/ml, lymph node dissection should be performed but
- •is not mandatory.
- •*Post-operative PSA = 0.5 ng/ml.
- •*Adequate haematological-, liver- and kidney function.
- •*Negative bone scan prior to study start.
- •*Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*M+ (Positive bone scan indicating spread of tumour).
- •*Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years.
- •*Previous hormonal manipulation (e.g. LHRH analogues and/or antiandrogens) affecting prostate cancer cells.
- •*Previous radiotherapy to pelvic region.
- •*Previous chemotherapy.
- •*Systemic corticosteroids within 6 months prior to randomisation.
- •*Unstable cardiovascular disease within 6 months prior to randomisation.
- •*Active untreated infectious disease.
- •*Active gastric ulcer.
- •*Known hypersensitivity to Polysorbate 80.
- •*Other serious illness or medical condition.
- •*Symptomatic peripheral neuropathy = CTCAE grade 2.
- •*Patients who by altered physical or psychological state not are able to co-operate or participate in the study.
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