PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,128
- 试验地点
- 46
- 主要终点
- Time to biochemical or clinical failure
研究概览
简要总结
This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.
详细描述
This study will look at the safety of curative radiotherapy to the prostate and lymph glands given in 5 visits, in men with high risk localised prostate cancer.
The purpose of the research is to test an advanced type of external beam radiotherapy called stereotactic body radiotherapy (also known as SBRT) in 1128 participants with high risk localised prostate cancer (that is, prostate cancer that has not spread beyond the prostate gland but is at high risk of growing quickly or spreading). Importantly, this treatment delivers a potentially curative dose of radiotherapy in only 5 treatments over two weeks. Half the participants in the trial will receive radiotherapy to the prostate, the other half will have radiotherapy to the prostate as well as the surrounding lymph nodes. The investigators will follow patients in the trial for at least three and half years to see which treatment is best. The investigators will be looking at whether it is safe to give this treatment by reviewing any side-effects that occur and also assessing whether giving SBRT to the lymph nodes as well as the prostate reduces the chance of prostate cancer returning.
The treatment will take place at NHS radiotherapy centres that are experienced in giving SBRT and radiotherapy to the pelvic nodes, and have been quality assured to deliver these treatments
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
- •Aged ≥ 18 years at randomisation
- •Histopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within twelve months of randomisation (unless otherwise discussed with the CI or co-Clinical Leads)
- •Patients planned for 12-36 months androgen deprivation therapy
- •High risk localised prostate cancer as defined by
- •Gleason 8-10 (grade groups 4 and 5) and/or
- •Stage T3a/b or T4 and/or
- •PSA > 20ng/ml (or >10 ng/ml for patients on 5-alpha reductase inhibitors)
- •Multi-parametric MRI of the pelvis- to include at least one functional MRI sequence in addition to T2W imaging within twelve months of randomisation
- •Radiological staging to exclude metastatic disease, prior to starting ADT, with one of the following: PSMA PET-CT, fluciclovine/choline PET-CT, whole-body MRI, bone scan, CT of chest, abdomen and pelvis (imaging method as per local practice/standard of care).
- •WHO performance status 0-2
- •Ability of research subject to give written informed consent
排除标准
- •N1 or M1 disease
- •PSA >50ng/ml (or >25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease
- •Previous active treatment for prostate cancer
- •Patients where SBRT is contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms N.B. where patient has repeated imaging showing bowel in close apposition to target volumes that would make pelvic radiotherapy highly unlikely to be deliverable should be excluded.
- •Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications
- •Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.
- •Patients who have had chemotherapy within 6 weeks of the start of radiotherapy.
- •Life expectancy < 5 years
结局指标
主要结局
Time to biochemical or clinical failure
时间窗: minimum of 3.5 years follow up post-randomisation
Time to biochemical or clinical failure as defined by time from randomisation to the first progression event (either biochemical failure, local recurrence, lymph node/pelvic recurrence, distant metastases, recommencement of androgen deprivation therapy or death due to prostate cancer).
次要结局
- Clinical reported acute toxicity(12 weeks post-randomisation)
- Overall survival(up to 5 years post-randomisation)
- Adherence to radiotherapy protocol(after completion of treatment)
- Prostate cancer-specific survival(up to 5 years post-randomisation)
- Clinical reported late toxicity(up to 5 years post-randomisation)
- Patient Reported Outcome Measures(up to 5 years post-randomisation)
- Metastatic relapse-free survival(up to 5 years post-randomisation)