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临床试验/NCT04067570
NCT04067570进行中(未招募)不适用

Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Study

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月7日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chia-Lin (Eric) Tseng

Principal Investigator

Sunnybrook Health Sciences Centre

研究点 (2)

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