Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 500
- 主要终点
- Biochemical disease-free survival
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.
详细描述
Eligible patients had clinically localized (clinical TNM classification T1 or T2), biopsy-proven adenocarcinoma of the prostate and were randomly treated with RRP or EBRT. Exclusion criteria included prior treatment for prostate cancer, the presence of metastatic disease on imaging studies, the receipt of neoadjuvant androgen ablation before registration, and an inability to read or understand Italian language. The institutional review boards of every participating centre approved the study design. Every patient enrolled signed an informed-consent form approved by the institutional review boards. Clinical information collected from the medical record included pre-treatment serum prostate-specific antigen (PSA) level, clinical T classification, and biopsy Gleason score. Follow-up assessments were completed before treatment and every 3 months after treatment. Subjects who sought primary treatment elsewhere or did not return follow-up questionnaires beyond the initial assessment were excluded from this analysis.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 75 years or younger
- •Diagnosis of prostate cancer, as verified by cytologic or histologic examination the tumor is well differentiated to moderately well differentiated
- •Untreated, clinically localized prostate cancer, with a tumor stage of T1, or T2
- •Prostate specific antigen (PSA) level of ≤10 ng/ml
- •Bone scan with no abnormalities
- •Health status that would permit radical prostatectomy
- •Life expectancy of more than 10 years.
排除标准
- •PSA >10 ng/ml
- •Bone scan consistent with metastatic disease
- •Other evidence that cancer of the prostate is not clinically localized
- •Life expectancy less than 10 years
- •Serum creatinine greater than 3 mg/dl
- •Myocardial infarction within last 6 months
- •Unstable angina Class III or IV
- •Severe pulmonary disease
- •Liver failure
- •Severe dementia
- •Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years.
结局指标
主要结局
Biochemical disease-free survival
时间窗: up to 12 months
Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. The definition of biochemical recurrence was based on a review of the literature and consideration of clinical practice in the year 1997. Biochemical recurrence among patients who underwent radical prostatectomy (RP) was defined as a measurable serum PSA concentration 0.2 ng/ml or greater. The American Society for Therapeutic Radiology and Oncology (ASTRO) criteria were used to define progression after radiation therapy. The ASTRO consensus definition specifies progression as 3 consecutive increases in serum PSA documented at intervals of 6 or more months.
次要结局
- Overall survival.(5, 7 and 10 years after treatment and every 5 years thereafter.)
- •Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).(1, 3, 6, 12 and 24 months after treatment.)
- •Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).(1, 3, 6, 12 and 24 months after treatment.)
- •Urinary symptoms measured by the International Prostate Symptom Score (IPSS).(1, 3, 6, 12 and 24 months after treatment.)
- •Sexual symptoms measured by the International Index of Erectile Function (IIES).(1, 3, 6, 12 and 24 months after treatment.)
- Prostate cancer-specific survival(3, 5, and 10 years after treatment and then every 5 years thereafter)
研究者
Savino M. Di Stasi
Associate Professor of Urology
University of Rome Tor Vergata