Clinical Trial to Study Quality of Life in Prostate Cancer Patients by Randomizing Anti-androgen Versus Total Androgen Blockage Prior to Curative Intended Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 主要终点
- Quality of Life
研究概览
简要总结
Phase III clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy.
详细描述
Primary objective: To study the difference in quality of life in relation to anti-androgen versus total androgen blockage.
Exploratory parameters: ▪ Time to PSA relapse
- Time to symptom giving metastasis
- Overall survival
Patients with localized /locally advanced prostate cancer were subject to treatment with curative intention. They could be divided into three groups according to the risk of metastasis. Mainly intermediate risk group of patients were included in this study. Patients with low risk could be included if they were subject to neo-adjuvant hormonal therapy. Different risk groups were defined as below:
Low risk group: PSA ≤10 ng/ml Gleason score ≤ 6 Tumour stage ≤ T2b Intermediate risk group: Presence of 1-2 factors of high risk. High risk group: PSA >10 ng/ml Gleason score ≥7 Tumour stage T2c - T3b
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Failure to fulfill inclusion criteria.
- •Severe hepatic or renal failure, according to clinical and laboratory examinations, serum creatinine > 225 mmol/l.
- •Concomitant diseases that would influence the planned treatment (e.g. Inflammatory bowel disease, urinary incontinence, severe atherosclerosis, myocardial infarction within last 6 months.
- •Previous diagnosis of other malignant diseases excluding patients who are free from relapse after at least 5 years of diagnosis. Patients with basal cell carcinoma are includable.
- •Inability of the patient to cope with the study rules, due to abuses, mentalstatus or other reasons
- •Participation in other clinical studies at the same time if it considers may hamper the assessment of QoL.
研究组 & 干预措施
Arm AA(anti-androgen)
Bicalutamide 150 mg per os daily + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.
干预措施: Bicalutamide (Drug)
Arm TAB (Total androgen blockade)
Bicalutamide 50 mg orally daily + Goserelin 3.6 mg subcutaneously every 28±2 days + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.
干预措施: Bicalutamide (Drug)
结局指标
主要结局
Quality of Life
时间窗: 4 years
次要结局
- Overall survival(1 year)
- PSA relapse(1year)
- Time to symptom giving metastasis(1 year)
研究者
khairul Majumder
MD
Karolinska University Hospital