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โ† Trials
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Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer

RecruitingNAAges 18 Years - anyMaleInstitute of Cancer Research, United Kingdom
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In plain words

What the trial is, and whether it could suit you

The purpose of this research is to investigate whether stereotactic body radiotherapy (SBRT), precise X-ray treatment, is best given in five treatments (also called fractions) over 10 days or in two treatments over 8 days. SBRT is an accurate way to deliver a high dose of radiotherapy to the prostate in a smaller number of doses. We have considerable experience with 5-dose SBRT and now wish to examine the feasibility and safety of delivering treatment over two, larger, doses. Previous work has shown it is theoretically possible to deliver two fraction SBRT on the MR-linac and previous studies have shown internal radiotherapy (brachytherapy) administered in two fractions to be a safe option for patients with low-risk prostate cancer. All treatment within this trial will be delivered on a new, state of the art, radiotherapy machine called an MR-linac (Magnetic Resonance Linear Accelerator

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Men aged โ‰ฅ18 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 5. PSA \<25 ng/ml prior to starting ADT (Androgen deprivation therapy) 6. Patients will be concurrently treated with androgen deprivation therapy (ADT) 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 (luteinizing hormone-releasing hormone) analogues if required. 7. WHO (World Health Organisation) 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. Exclusion Criteria: 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia) 2. International Prostate Symptom Score (IPSS) 13 or higher 3. Post-void residual \>100 mls 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 excluding 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.
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What it tests

  • SBRT
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Where

1 site
The Royal Marsden Nhs Foundation Trust
Sutton, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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