NCT00110162Unknown3 期
A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
Peter MacCallum Cancer Centre, Australia38 个研究点 分布在 2 个国家目标入组 2,000 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 2,000
- 试验地点
- 38
- 主要终点
- Death from any cause at 8 years
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens.
PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare overall survival (with acceptable morbidity) of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy (ADT).
Secondary
- Compare cancer-specific survival of patients treated with these regimens.
- Compare clinical progression in patients treated with these regimens.
- Compare time to first androgen independence in patients treated with these regimens.
- Compare complication rate incidence and timing (e.g., cord compression or pathological failure) in patients treated with these regimens.
- Compare treatment-related morbidity (including cognitive morbidity or osteoporosis) in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Determine prognostic factors for progression in patients treated with delayed ADT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Prostate-specific antigen (PSA) relapse OR incurable disease diagnosed within the past 2 months AND meets criteria for either of the following groups:
- •In PSA relapse after definitive radical treatment (prostatectomy or radiotherapy), as evidenced by 1 the following:
- •Post-prostatectomy PSA level ≥ 0.2 ng/mL
- •At least 3 rising PSA levels (post-radiotherapy) obtained ≥ 1 month apart, with the last PSA obtained within the past 2 months
- •No metastatic disease by bone scan or abdomino-pelvic CT scan
- •Not suitable for radical treatment at primary diagnosis
- •Not planning to receive curative treatment
- •Localized or metastatic disease
- •No symptomatic disease requiring radiotherapy or immediate hormonal therapy
- •No symptomatic disease requiring therapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •At least 5 years
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No other significant comorbid condition that would limit life expectancy to < 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •At least 12 months since prior androgen deprivation therapy (ADT) administered in the neoadjuvant or concurrent (with radiotherapy) setting (group 1)
- •No prior ADT (group 2)
- •Radiotherapy
- •See Disease Characteristics
- •See Endocrine therapy
- •See Disease Characteristics
- •No concurrent enrollment in TROG-96.01 or TROG-RADAR protocols
排除标准
- 未提供
结局指标
主要结局
Death from any cause at 8 years
次要结局
- Cancer specific survival
- Clinical progression
- Time to first androgen independence
- Complication rate incidence and timing (e.g., cord compression, pathological fracture)
- Treatment-related morbidity (including cognitive, osteoporosis)
- Prognostic factors for progression (delayed group)
- EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
- CTC v3.0 Survival endpoints: actuarial analysis at eight years
- Morbidity continuously
研究者
研究点 (38)
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