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EPIC questionnaire: to assess typical symptoms after radiotherapy in prostate cancer patients. EQ-5D: a commonly used generic questionnaire to measure health-related QoL used to asess mobility, self-care, usual activities, pain\u002Fdiscomfort, anxiety\u002Fdepression \\& the subject's perceptions of their own current overall health. A QoL analysis plan will be developed in consultation with the TMG with key endpoints for each questionnaire. Standard algorithms will be used to derive scores and handle missing data. Changes from baseline at each time point will be compared within groups as well as between treatment groups (by means of ordinal logistic regressions or ANCOVA models). Analyses to account for the longitudinal nature of the data may be used.",{"measure":34,"description":35,"timeFrame":36},"Adherence to radiotherapy protocol","Qualitative analysis of adherence to pre-specified radiotherapy dose constraints with radiotherapy quality assurance to demonstrate feasibility in a muliticentre setting.","after completion of treatment",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","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.\n\nThe 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.\n\nThe 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",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"P-SBRT","ACTIVE_COMPARATOR","Participants allocated P-SBRT will receive 36.25Gy in 5 fractions to the prostate and seminal vesicles on alternate days (40Gy to prostate CTV).",[51],"Radiation: SBRT",{"label":53,"type":54,"description":55,"interventionNames":56},"PPN-SBRT","EXPERIMENTAL","Participants allocated PPN-SBRT will receive 36.25Gy in 5 fractions to the prostate and seminal vesicles on alternate days (40Gy to prostate clinical target volume (CTV)) and 25Gy in 5 fractions 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Radiological staging to exclude metastatic disease, prior to starting ADT, with one of the following: PSMA PET-CT, fluciclovine\u002Fcholine PET-CT, whole-body MRI, bone scan, CT of chest, abdomen and pelvis (imaging method as per local practice\u002Fstandard of care).\n7. WHO performance status 0-2\n8. Ability of research subject to give written informed consent\n\nExclusion Criteria:\n\n1. N1 or M1 disease\n2. PSA \\>50ng\u002Fml (or \\>25ng\u002Fml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease\n3. Previous active treatment for prostate cancer\n4. 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.\n5. Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications\n6. Bilateral hip prostheses or any other implants\u002Fhardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.\n7. Patients who have had chemotherapy within 6 weeks of the start of radiotherapy.\n8. Life expectancy \\\u003C 5 years","MALE","18 Years",{"count":556,"type":557},1128,"ESTIMATED","INTERVENTIONAL",[560],"PHASE3","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.",[563],"Prostate Cancer","2024-09-04",{"date":566,"type":567},"2024-09-19","ACTUAL",{"date":569,"type":567},"2022-09-09",{"date":571,"type":557},"2030-06",{"name":5,"class":6},42]