NCT06523634招募中不适用
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 22
- 主要终点
- SBRT impact on patient-reported GI and GU symptoms
研究概览
简要总结
This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.
详细描述
This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed.
All subjects will be randomly assigned in a 1:1 ratio:
- Experimental arm: Radiotherapy treatment in 5 fractions.
- Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).
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
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
- •Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
- •Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA >0.1 ng/mL , or three consecutive PSA rises)
- •Age ≥18 years
- •Ability to understand and willingness to sign a study-specific informed consent prior to study entry
- •Ability to understand and answer the EPIC-26 form in one of the languages available
排除标准
- •Patients with a pT4 tumor at prostatectomy
- •Patients with previously pathologically confirmed N1
- •Patients with macroscopically involved margin at surgery (R2)
- •Patients with a history of distant metastases
- •Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter >1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.
- •Latest PSA > 2ng/ml
- •Patients with a IPSS >20
- •Gleason 10 tumor
- •Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
- •Prior pelvic radiotherapy
- •Prior hormonal therapy started more than 6 weeks before randomization
- •History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
- •Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.
研究组 & 干预措施
SBRT
Experimental
SBRT: 5 fractions
干预措施: Stereotactic body radiotherapy (SBRT) (Radiation)
Control
Active Comparator
Standard of care radiotherapy
干预措施: SOC RT (Radiation)
结局指标
主要结局
SBRT impact on patient-reported GI and GU symptoms
时间窗: 2 years post treatment
Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).
次要结局
- Blood lymphocyte evolution between study arms(5 years)
- Physician-scored toxicity(up to 5 years)
- Patient Reported Outcomes(at end of RT and following time-points counted from start of RT : 4-7 weeks (only in experimental arm), 3 months, 6 months, 1 year and yearly up to 5 years)
- Ccost-utility during radiotherapy(during radiotherapy)
- To compare local and regional recurrences between study arms, up to 5 years.(5 years)
- To compare biochemical progression-free survival (bPFS) to historical control and between study arms(5 years)
- To compare Overall survival (OS) between study arms, up to 5 years.(5 years)
- To compare distant metastases-free survival (dmFS) between study arms(5 years)
研究者
研究点 (22)
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