A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 13
- 主要终点
- Disease-specific Survival
研究概览
简要总结
RATIONALE: Sometimes prostate tumours may not need treatment until they progress. In this case, observation may be sufficient. Radical treatments, such as radical prostatectomy or radiation therapy, may be effective in treating prostate cancer when it is first diagnosed. It is not yet known whether active surveillance is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer.
PURPOSE: This randomized phase III trial is studying active surveillance to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer.
详细描述
OBJECTIVES:
Primary
- To compare disease-specific survival of patients with favorable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis vs active surveillance and selective intervention based on pre-specified biochemical, histological, or clinical progression criteria.
Secondary
- To compare overall survival, quality of life using the EPIC-26, RAND SF-12, and State-Trait Anxiety Inventory, distant disease-free survival, PSA relapse/progression after radical intervention, and initiation of androgen deprivation therapy between the two treatment arms.
- To determine the proportion of patients on the active surveillance arm who receive radical intervention for prostate cancer.
- To determine if PSA doubling-time prior to diagnosis predicts eventual outcome.
- To determine if molecular biomarkers predict outcome.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Diagnosed within 6 months prior to randomization
- •Patient has been classified as favorable risk as defined by the following:
- •Clinical stage T1b, T1c, T2a, or T2b at the time of diagnosis
- •Clinical (diagnostic biopsy) Gleason score ≤ 6
- •PSA ≤ 10.0 ng/mL
- •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
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0, 1, or 2
- •Patient has a minimum life expectancy of > 10 years
- •In centers participating in the quality of life component of the study, the patient is able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
- •No history of other malignancies, except adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years from study randomization
- •PRIOR CONCURRENT THERAPY:
- •No previous treatment for prostate cancer, including surgery (excluding biopsy and TURP), radiotherapy, or androgen deprivation therapy for greater than 3 months
- •No planned androgen therapy except in the context of radical therapy
排除标准
- 未提供
研究组 & 干预措施
Active Surveillance
Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
Radical Intervention
Radical prostatectomy or radiotherapy based on patient and physician preference
干预措施: conventional surgery (Procedure)
Radical Intervention
Radical prostatectomy or radiotherapy based on patient and physician preference
干预措施: brachytherapy (Radiation)
Radical Intervention
Radical prostatectomy or radiotherapy based on patient and physician preference
干预措施: external beam radiation therapy (Radiation)
Radical Intervention
Radical prostatectomy or radiotherapy based on patient and physician preference
干预措施: Biopsies (Procedure)
结局指标
主要结局
Disease-specific Survival
时间窗: 5 years 6 months
Time from the date of randomization to the date of death due to prostate cancer.
次要结局
- Overall Survival(5 years 6 months)