EUCTR2008-003138-33-NL进行中（未招募）1 期
A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxotere? (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA. - PSA-ERECT
Scandinavian Prostate Cancer Group (SPCG)0 个研究点目标入组 430 人开始时间: 2009年7月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
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 =80 years of age.
- •*WHO/ECOG performance status 0 – 1.
- •*Histological proven adenocarcinoma of the prostate.
- •*Patients who are planned to receive antiandrogen treatment,
- •*After Curative treatment
- •- Prostatectomy: PSA >10 OR PSA DT < 6 months and PSA > 5 (PSA doubling time calculation must start at a minimum value of >1.0)
- •- Radiation: PSA > +2.0 above nadir and PSA >10 OR PSA DT < 6 months and PSA > 5. (PSA bouncing after radiotherapy should be excluded according to the local traditions, and PSA doubling time calculation must start at a minimum value of >1.0)
- •*In locally advanced (or local not suitable for curative therapy) prostate cancer patients, PSA < 100 is required before inclusion AND one of the following
- •- PSA DT < 6 months or
- •- PSA >20 or
- •- Gleason score 8-10,
- •*Previous hormonal therapy in conjunction with radiotherapy is allowed, provided that the total duration of therapy does not exceed 12 months and has to be stopped > 12 months ago.
- •*Testosterone within 50% of normal range
- •*Adequate haematological-, liver- and kidney function.
- •*Negative bone scan (Optional: thorax, abdomen and pelvis CT or ultrasound prior to trial 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
- •*Positive Bone scan
- •*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 5 years.
- •*Previous chemotherapy or randomised in SPCG 12/AdPro or SPCG 13/AdRad.
- •*Systemic corticosteroids within 6 months prior to randomisation.
- •*Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
- •*Active untreated infectious disease, including tuberculosis, MRSA.
- •*Active gastric ulcer.
- •*Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)
- •*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 trial.
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxotere? (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA. - PSA-ERECTPatients with prostate cancer.The study will include two patient cohorts, which at inclusion has a similar risk for progression of the disease at 5 years, and risk of later prostate cancer death. The first patient group are patients with PSA relapse after curative treatment, and the 2nd one are patients with locally advanced disease.MedDRA version: 9.1Level: LLTClassification code 10036910Term: Prostate cancer NOSEUCTR2008-003138-33-FIScandinavian Prostate Cancer Group (SPCG)430
招募中
3 期
A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.prostate carcinoma1003858810036958Prostate cancerNL-OMON35597Scandinavian Prostate Cancer Group20
进行中（未招募）
1 期
A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxotere? (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.Patients with prostate cancer.The study will include two patient cohorts, which at inclusion has a similar risk for progression of the disease at 5 years, and risk of later prostate cancer death. The first patient group are patients with PSA relapse after curative treatment, and the 2nd one are patients with locally advanced disease.EUCTR2008-003138-33-DKScandinavian Prostate Cancer Group (SPCG)430
进行中（未招募）
1 期
A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxotere? (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA. - SPCG 14Patients with prostate cancer.The study will include two patient cohorts, which at inclusion has a similar risk for progression of the disease at 5 years, and risk of later prostate cancer death. The first patient group are patients with PSA relapse after curative treatment, and the 2nd one are patients with locally advanced disease.EUCTR2008-003138-33-SEScandinavian Prostate Cancer Group (SPCG)430
进行中（未招募）
不适用
A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation with Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following Definitive Local TherapyClinically asymptomatic prostate cancer subject with a rising PSA following definitive local therapyMedDRA version: 13.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-000323-17-DEsanofi-aventis US412