About this trial
This study is a single centre feasibility trial. The trial will recruit men with intermediate risk localised prostate cancer who will all receive targeted dose (escalated/de-escalated dose directed by MRI) 5 fraction SBRT to the prostate.
Trial Objectives are:
1. Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects 2. Secondary
* To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men aged ≥18 years
Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
MRI stage T2 or less (as staged by AJCC TNM 2018)
Disqualifiers
Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
IPSS 19 or higher
High grade disease (GG3) occult to MRI-defined lesion
Post-void residual >100 mls, where known
Trial design
Single group
Treatments tested in this trial
MR Linac delivered Radiotherapy
RadiationAll radiotherapy will be delivered on the MR-linac. The whole prostate will receive 30 Gy in 5 fractions and the dominant lesion plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Treatment groups
Trial outcomes
Primary outcomes
Technical Feasibility
To establish the technical feasibility of treating prostate cancer with toxicity-minimising. radiotherapy on an MR-linac. Patients will be followed up for recurrence/biochemical failure as per standard care.
Secondary outcomes
Acute and Late Toxicities
CTCAE Version 5
Sponsors and contacts
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