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.
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
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.
Parallel
SBRT
RadiationStereotactic Body Radiotherapy
Time to biochemical or clinical failure
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).
Clinical reported acute toxicity
Clinical reported acute and late toxicity using CTCAE version 5.0 and RTOG criteria. Focus will be given to GU and GI Grade 2 or higher (G2+) toxicities
Clinical reported late toxicity
Clinical reported acute and late toxicity using CTCAE version 5.0 and RTOG criteria. Focus will be given to GU and GI Grade 2 or higher (G2+) toxicities
Metastatic relapse-free survival
Time from randomisation to distant metastases or death from prostate cancer
Prostate cancer-specific survival
Time from randomisation to death due to prostate cancer
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Institute of Cancer Research, United Kingdom
Lead sponsor
Prostate Cancer UK
Collaborator
