PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 538
- 试验地点
- 16
- 主要终点
- 5-year progression-free survival
研究概览
简要总结
After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years.
The standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT.
The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 Gy.
The study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA < 1.0 ng/ml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will be included. PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises will be included.
All eligible patients will be randomized to one of the following two treatment arms:
Arm 1 = Conventional sEBRT to apply a total dose of 70 Gy in 35 daily fractions of 2 Gy during 7 weeks.
Arm 2 = Hypofractionated sEBRT to apply a total dose of 60 Gy in 20 fractions of 3 Gy during 4 weeks.
The primary endpoint will be the 5-year progression-free survival (PFS) after treatment.
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
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with prostate adenocarcinoma treated with radical prostatectomy;
- •Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;
- •No lymph node or distant metastases. A recent PSMA-PET scan (< 60 days) without evidence of lymph node or distant metastases;
- •PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;
- •PSA at inclusion < 1.0 ng/mL;
- •WHO performance status 0-2 at inclusion;
- •Age at inclusion between 18 and 80 years;
- •Written (signed and dated) informed consent prior to registration.
排除标准
- •Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
- •Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;
- •Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;
- •Double-sided metallic hip prosthesis;
- •Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
研究组 & 干预措施
Conventional
Conventional sEBRT
干预措施: Conventional sEBRT (Radiation)
Hypofractionation
Hypofractionated sEBRT
干预措施: Hypofractionated sEBRT (Radiation)
结局指标
主要结局
5-year progression-free survival
时间窗: 5 years
Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first
次要结局
- Metastasis-free survival(5 years)
- Prostate cancer-specific mortality(5 years)
- Late grade ≥ 2 gastrointestinal toxicity(Up to 5 years after completion of the RT)
- Overall survival(5 years)
- Acute grade ≥ 2 gastrointestinal toxicity(Up to 3 months after completion of the RT)
- Acute grade ≥ 2 genitourinary toxicities(Up to 3 months after completion of the RT)
- Late grade ≥ 2 genitourinary toxicity(Up to 5 years after completion of the RT)
- Quality of life after radiation(Up to 5 years after completion of the RT)