NCT01717677终止不适用
Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
Association of Urologic Oncology (AUO)3 个研究点 分布在 1 个国家目标入组 457 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 457
- 试验地点
- 3
- 主要终点
- Prostate cancer-specific survival
研究概览
简要总结
4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk
详细描述
The study will compare four possible therapy options for treatment of newly diagnosed prostate cancer with low or "early intermediate" risk according to the patients preferences.
The Following hypotheses will be tested:
- Radiation is not relevantly worse compared to prostatectomy with regard to time to prostate cancer-related deaths
- Permanent seed implantation therapy not inferior to prostatectomy with regard to time to prostate cancer-related deaths.
- Active Surveillance does not lead to a significant decrease of time to prostate cancer-related deaths compared to prostatectomy.
That for patients with newly diagnosed prostate cancer will be randomized into one of the four treatment arms. Randomization may be limited to at least two of the four treatment arms if a patient refuses one or two of the four treatment arms according to his own preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided biopsy by standardized protocol)
- •Men aged 18-75 years
- •Recruitment within 3 months after histological confirmation
- •Localized prostata cancer <= cT2a, NX or N0 M0
- •PSA <= 10 ng / ml
- •Gleason score <= 7a (3 +4)
- •ECOG performance status 0 or 1
- •<= 30% positive biopsy cores with largest contiguous tumor length <= 5 mm
- •IPSS score < 18
- •Urine flow (Qmax):> 15 ml / s
排除标准
- •Unifocal Gleason 6 cancer <1mm
- •History of treatment for BPH e.g. TURP, HIFU or cryotherapy
- •History of radiation therapy to the pelvis
- •Life expectancy <10 years
- •ASA >= 4
- •Post-void residual urine > 50 ml
- •Prostate volume on transrectal ultrasound > 60 cm3
- •large median prostate lobe visualized on transrectal ultrasound
- •chronic intestinal inflammatory disease covering the rectum
- •Other active malignancy within the past 5 years (except for superficial basal cell carcinoma or non muscle infiltrating bladder carcinoma)
- •contraindications for prostatectomy, radiation therapy or Active Surveillance
- •Patients refusing written informed consent
结局指标
主要结局
Prostate cancer-specific survival
时间窗: minimal observation time of 13 years for last study patient
次要结局
- - Complications / Safety(median 15 years)
- - Occurrence of the first progression on hormone therapy(17 years)
- - Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline(before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years)
- - Overall survival(minimal observation time of 13 years for last study patient)
- - Time to onset of hormone therapy(17 years)
研究者
研究点 (3)
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