A pilot study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MR

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Men aged >=18 years 2. Histological confirmation of prostate adenocarcinoma
requiring radical radiotherapy 3. Gleason score 3+3, 3+4 or 4+3 (Grade groups
1, 2 or 3) 4. MRI stage T2 or less (as staged by AJCC TNM 2018) 5. MRI-visible
tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging
and/or dynamic contrast-enhanced imaging with concordant pathology 6. Dominant
lesion <50% of prostate on any axial slice and <50% total prostate volume 7.
PSA <20 ng/ml prior to starting ADT 8. Patients can be concurrently treated
with androgen deprivation therapy if this would be standard of care. LHRH
analogues or Bicalutamide are permitted. ADT is not mandatory where this would
usually be omitted. 9. WHO Performance status 0-2 10. Ability of the
participant understand and the willingness to sign a written informed consent
form. 11. 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. IPSS 19 or higher 3. High grade disease (GG3) occult to
MRI-defined lesion 4. Post-void residual >100 mls, where known 5. Prostate
volume >90cc 6. Comorbidities which predispose to significant toxicity (e.g.
inflammatory bowel disease) or preclude long term follow up 7. Unilateral or
bilateral total hip replacement, or other pelvic metalwork which causes
artefact on diffusion-weighted imaging 8. Previous pelvic radiotherapy 9.
Patients needing >6 months of ADT due to disease parameters. 10. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Technical feasibility of treating prostate cancer with toxicity-minimising<br /><br>radiotherapy on an MR-linac. Feasibility is defined as coverage of GTV boost<br /><br>D90% >42Gy on the post-treatment imaging.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at<br /><br>baseline and the end of treatment then at 4 weeks and 3 months post-treatment.<br /><br>• Late toxicity (CTCAE) at 1 and 2 years post-treatment<br /><br>• Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5<br /><br>questionnaires.<br /><br>Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2<br /><br>years post treatment.<br /><br>• PSA control and kinetics at 2 years post-treatment<br /><br>• PSA control yearly until 5 years </p><br>

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