Prophylactic Versus Therapeutic Alpha-Blockers in Prostate Cancer Patients Undergoing Radical Course Radiation Therapy ± HDR Boost. a GROUQ Phase III Randomized Clinical Trial (PCS-VII).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- To determine the rate of increase and the mean difference from the baseline IPSS score in the alpha-blocker (Rapaflo) group compared to the standard arm.
研究概览
简要总结
Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop symptomatic urinary problems .These symptoms can significantly diminish a patient's quality of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease resistance to urinary flow.
This multi-institutional phase III trial is designed to compare standard of care versus preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group, whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy or if/when symptoms appear.
详细描述
The efficacy of Rapaflo treatment will be assessed using the International Prostate Symptom Score (IPSS). The IPSS will be assessed at baseline before RT, 4 weeks into RT, the last day of RT, and monthly thereafter for a total duration of 6 months from start of RT. Patients will have 2 more IPSS assessments at 9 and 12 months. The total duration of follow-up will be one year from start of RT. We will compare the rate of IPSS increase in the Rapaflo group compared to the standard arm at different time point (4 weeks, 6 weeks and at the end of treatment). We will also determine the rate of IPSS return to baseline at 4 and 12 weeks after the end of treatment. The rate of therapy dependence in the 2 arms will be evaluated at 20 and 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult male 18 years of age or older
- •Patients with confirmed diagnosis of adenocarcinoma of the prostate.
- •The primary treatment should be external beam radiation therapy (EBRT) with or without high dose rate (HDR) brachytherapy boost.
- •Clinical or radiological diagnosis of T1a - T3b.
- •No limitation with respect to Gleason score.
- •No limitation with respect to total Prostate-specific Antigen (PSA) value.
- •Karnofsky performance score (KPS) of ≥ 70.
排除标准
- •Small cell cancer of the prostate
- •T4 disease, invading bladder or rectum.
- •Adjuvant or salvage radiation therapy
- •Brachy monotherapy
- •KPS < 70
研究组 & 干预措施
Preventive administration of Rapaflo
Rapaflo treatment will start on day one of radiation therapy (early administration- before symptoms onset) and continue for a total duration of 6 months: 8 mg daily during 4 months and 8 mg every other day for 2 months.
干预措施: Preventive administration of Rapaflo (Drug)
Standard care
Administration of alpha-blocker Rapaflo at the onset of symptomatic urinary problems caused by radiation therapy. 8 mg of Rapaflo is administered daily until disappearance of symptoms.
干预措施: Standard Care (Drug)
结局指标
主要结局
To determine the rate of increase and the mean difference from the baseline IPSS score in the alpha-blocker (Rapaflo) group compared to the standard arm.
时间窗: IPSS will be assessed before radiation therapy (RT), 4 weeks into RT, the last day of RT, and monthly for first 6 months and also at 9 and 12 months from the start of RT.
次要结局
- To determine the rate of IPSS return to baseline, in the alpha-blocker (Rapaflo) group compared to the standard after the end of radiation treatment.(IPSS score will be assessed at before radiation therapy (RT), at 4 and 12 weeks after the end of RT.)
- To determine the rate of therapy dependence in both groups.(At 3 and 6 months from start of radiation therapy.)
研究者
Dr. Tamim Niazi
Radiation Oncologist
Sir Mortimer B. Davis - Jewish General Hospital