The HERMES trial: Hypofractionated Expedited Radiotherapy for Men with localisEd proState cancer. A phase II randomised study of ultrahypofractionated stereotactic body radiotherapy in men with localised prostate cancer

Institute of Cancer Research0 个研究点目标入组 46 人开始时间: 2021年2月26日最近更新: 2023年9月4日

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•All participants will be recruited at The Royal Marsden Hospital in the UK. Eligible men will be identified in oncology clinics and discussed at Multi-Disciplinary Team (MDT) meetings at The Royal Marsden.
•1. Men aged =18 years
•2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
•3. Gleason score 3+4 or 4+3 (Grade groups 2 or 3)
•4. MRI stage T3a or less (as staged by AJCC TNM 2018)
•5. PSA < 25 ng/ml prior to starting ADT
•6. Patients will be concurrently treated with androgen deprivation therapy for at least 6 months, as per standard of care. Men who need longer courses of ADT (maximum 12 months) will be considered on a case-by-case basis, and bicalutamide monotherapy is accepted as an alternative to LHRH analogues if required
•7. WHO Performance status 0-2
•8. Ability of the participant understand and the willingness to sign a written informed consent form
•9. Ability/willingness to comply with the patient-reported outcome questionnaires schedule throughout the study

•1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
•2. IPSS 13 or higher
•3. Post-void residual > 100 ml
•4. Prostate volume > 80cc
•5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
•6. Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
•7. Previous pelvic radiotherapy
•8. Patients needing 2-3 years of ADT due to disease parameters
•9. Previous invasive malignancy within the last 2 years except basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
•10. Patients will all be concurrently treated with Androgen deprivation therapy for at least 6 months, as per standard of care. Men who need longer courses of ADT may be considered on a case by case basis, and bicalutamide monotherapy is accepted as an alternative to LHRH analogues if required. Men who do not need/are not able to have hormone therapy are also included

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