Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events
研究概览
简要总结
Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer.
详细描述
The present study will be conducted as a prospective, prospective, single-centre, single-arm clinical trial. Patients after radical prostatectomy with high-risk pathological factors will receive hypofractionated post-prostatectomy radiotherapy in 15 fractions. The primary endpoint of the study is incidence of radiotherapy-related gastrointestinal and genitourinary adverse events,judging by (CTCAE)5.0. The secondary endpoints are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS) and radiological progression-free survival (RPFS), economic evaluations, self-assessment of quality of life including Abbreviated Version of the Expanded Prostate Cancer In-dex Composite Instrument (EPIC-26) and Physical Activity Rank Scale-3 (ARS-3), overall survival (OS) and prostate cancer-specific survival (CSS).
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
- 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
- •ECOG performance status 0-
- •Pathologically confirmed prostate cancer and completion of radical prostatectomy.
- •Postoperative pathological staging pT 3a, pT 3b, pT 4, surgical margins (+) or N1; or serum PSA ≥0.1ng/ml at 6 weeks postoperatively; or serum PSA <0.1ng/ml at 6 weeks postoperatively, with two consecutive persistently elevated PSA (≥0.1ng/ml) without signs of metastasis on clinical imaging (whole-body bone scan (ECT), magnetic resonance imaging (MRI), 68Ga PSMA PET/CT, etc.) .
- •Expected survival time >5 years.
- •Voluntarily accepted this experimental study protocol after being informed of the available treatment options.
排除标准
- •Patients with poor recovery of continence after radical prostatectomy.
- •Patients with a history of pelvic and abdominal radiotherapy.
- •Patients who participated in other clinical trials that were repugnant to the intervention of this trial within 4 weeks prior to the start of this trial.
- •Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis.
- •Patients who are deemed unfit to participate in this clinical trial in the judgement of the investigator, for instance, patients with serious systemic diseases that, in the judgement of the investigator, may interfere with the treatment and evaluation of this trial and its compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, urological and other systemic diseases.
- •Patients with radiotherapy-related contraindications.
- •Patients who cannot provide written informed consent and have poor adherence to treatment.
结局指标
主要结局
Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events
时间窗: through study completion, an average of 3 years
Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events
次要结局
- quality of life(QoL)(through study completion, an average of 3 years)
- progression-free survival (PFS)(Assessment progression-free survival (PFS) at 3 years)
- overall survival (OS)(Assessment overall survival (OS) at 3 years)
- medical expenses(through study completion, an average of 3 years)
- prostate cancer-specific survival (CSS)(Assessment prostate cancer-specific survival (CSS) at 3 years)