Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acute genitourinary (GU) and gastrointestinal (GI) toxicities
研究概览
简要总结
Radical prostatectomy is a common treatment for localized prostate cancer. More than 30% of men who undergo surgery will subsequently develop recurrence, particularly in patients with adverse features where the risk may be even higher. Recurrence typically manifests as a rise in serum-level of prostate-specific antigen (PSA), referred to as biochemical recurrence. Post-operative radiotherapy is a potentially curative option for many patients, as shown in multiple prior randomized studies. A standard course of post-operative radiation requires 6 to 6 and half weeks of treatment, 5 days a week; however, new high-precision radiation techniques with image guidance, termed stereotactic body radiotherapy (SBRT), can deliver an equivalent or higher dose of treatment in 5 visits. Our group, amongst others, have demonstrated in previous studies, that the new 5-treatment technique was safe, convenient and effective in patients with intact prostates. Currently, limited data exists on this approach after prostatectomy. This study will be one of the first to assess the side effect profile and efficacy of SBRT in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •• Histologically confirmed diagnosis of adenocarcinoma of the prostate
- •Completed written informed consent
- •Able and willing to complete self report questionnaires
- •Pathologic stage T3 or T4 (without any gross residual disease), NX-0, M0, and/or +ve surgical margins, and/or a rising PSA post-radical prostatectomy on at least 2 consecutive measurements
排除标准
- •• Gross residual disease
- •Histological or radiological node +ve (N1) or distant metastases (M1)
- •Prior pelvic radiotherapy
- •Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
- •Hip prosthesis
结局指标
主要结局
Acute genitourinary (GU) and gastrointestinal (GI) toxicities
时间窗: Through accrual completion, up to 3 years
Based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
次要结局
- Incidence of late GU and GI toxicities (≥6 months)(Through accrual completion, up to 3 years)
- Biochemical disease-free survival (bDFS)(Through study completion, up to 3 years)
研究者
Chia-Lin (Eric) Tseng
Principal Investigator
Sunnybrook Health Sciences Centre
