Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45/62.5 Gy in 25 Fractions vs. 43/52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 434
- 试验地点
- 4
- 主要终点
- Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity
研究概览
简要总结
Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule.
Why is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.
What is being compared?
Standard treatment (Arm A):
25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy
Shorter treatment (Arm B):
20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy
Both groups may also receive hormone therapy (ADT) for 6-24 months.
Main Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.
Other Things to be Measured
Cancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)
Who can join?
Men who:
Had prostate surgery Have a detectable PSA (≥0.2 ng/mL) No distant metastasis Are in good general health (ECOG 0-2)
How long will the study last?
About 12 years total:
2 years to enroll patients 10 years of follow-up
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
- •Histologically confirmed prostate adenocarcinoma.
- •Prior radical prostatectomy with detectable PSA (≥0.2 ng/mL).
- •No evidence of distant metastasis (confirmed via bone scan and CT/MRI or TEP-PSMA if PSA is above 0.5 ng /ml).
- •Patient with Nodal recurrence within the pelvis are eligible
- •ECOG performance status 0-
- •Age ≥ 18 years.
- •Adequate baseline renal, hepatic, and hematologic function.
排除标准
- •Prior pelvic radiotherapy.
- •Macroscopic local relapse on imaging
- •Presence of metastatic disease.
- •Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.
- •Uncontrolled comorbidities affecting study participation.
- •Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).
结局指标
主要结局
Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity
时间窗: Within 24 months after completion of radiotherapy.
The proportion of patients experiencing Grade 2 or higher GU or GI adverse events, assessed according to CTCAE v5.0 criteria, following post-operative salvage radiotherapy. This outcome measures treatment-related toxicity in both study arms.
次要结局
- Progression-Free Survival (PFS)(Up to 10 years post-treatment.)
- Biochemical Progression-Free Survival (bPFS)(Up to 10 years post-treatment.)
- Metastasis-Free Survival (MFS)(Up to 10 years post-treatment.)
- Time to Initiation of Systemic Salvage Therapy(Up to 10 years post-treatment.)
- Overall Survival (OS)(Up to 10 years post-treatment.)
- Expanded Prostate Cancer Index Composite-26 (EPIC-26)(Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.)
- International Prostate Symptom Score (IPSS)(Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.)
- Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.)