ACTRN12611000027910终止3 期
A phase III study comparing the disease-specific survival of active surveillance therapy against radical treatment in patients diagnosed with favourable risk prostate cancer (START).
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Patients must fulfil all of the following criteria to be eligible for admission to the study: * Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization. & Patient has been classified as favourable risk as defined by the following: * Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis; Clinical (diagnostic biopsy) Gleason sum < 7; PSA < 10.0 ng/ml (ug/L) Note: patients who have received prior treatment with 5-alpha reductase inhibitors (5ARI) must adhere to the following criteria: * < 2 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 10.0 (ng/ml or ug/L) to be eligible. * 2-6 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 7.0 (ng/ml or ug/L) to be eligible. * > 6 months months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 5.0 (ng/ml or ug/L) to be eligible. * Physical examination, rectal examination and transrectal ultrasound have been done within 6 months prior to randomization and radiographic studies, if indicated, are negative for metastasis. * Patient is a suitable candidate for radical prostatectomy or radiotherapy. * No previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, and androgen deprivation therapy for greater than 3 months. * ECOG Performance Status 0, 1 or 2. * Patient has a minimum life expectancy of > 10 years. * The patient is willing to complete the quality of life questionnaires in English unless unable due to illiteracy in English, loss of sight, or other equivalent reason. * Patient consent has been obtained according to local Institutional and/or University Human Experimentation Committee requirements. * Patient is accessible for treatment and follow-up. * Protocol treatment is to begin within 90 days of randomisation.
排除标准
- •Patients who fulfil any of the following criteria are not eligible for admission to the study:
- •* History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumours curatively treated with no evidence of disease for > 5 years from randomisation.
- •* Planned androgen therapy except in the context of radical therapy.
研究者
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