Dose De-escalation in Prostate Radiotherapy Using the MRL

Recruiting now · Not applicable

Conditions studied: Prostate Adenocarcinoma

In brief

The goal of this feasibility study is to learn about dose de-escalation in the treatment of men with intermediate risk prostate cancer. The main question it aims to answer is the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an Magnetic Resonance Linear Accelerator (MR-linac). It will also examine gastrointestinal and genitourinary toxicity in the acute and late setting post radiotherapy as well as Prostate-Specific antigen (PSA) control up until 2 years post treatment. Participants will be treated with radiotherapy to the prostate with which will be given in 30Gy in 5 fractions to the whole prostate and 45Gy in 5 fractions to the dominant lesion.

Key facts

Study ID

NCT05709496

Run by

Royal Marsden NHS Foundation Trust

People needed

20

Starts

2023-03-01

Expected to finish

2027-03-01

Last updated by the study team

2024-04-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• MRI-visible tumour(s) of Prostate Imaging-Reporting and Data System (PIRADS) v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology
• Tumour nodule visible on MRI occupying <50% of prostate on any axial slice and <50% total prostate volume
• PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT)
• Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. Luteinizing hormone-releasing hormone (LHRH) analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.
• World Health Organisation (WHO) Performance status 0-2
• Ability of the participant understand and the willingness to sign a written informed consent form.
• Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.

You may not qualify if…

• 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
• Prostate volume >90cc
• Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
• Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
• Previous pelvic radiotherapy
• Patients needing >6 months of ADT due to disease parameters.
• Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder

Where it is running

• The Royal Marsden Hospital — Sutton, Surrey, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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