Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05709496

Dose De-escalation in Prostate Radiotherapy Using the MRL

Led by Royal Marsden NHS Foundation Trust · Updated on 2024-04-19

20

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dose De-escalation in Prostate Radiotherapy Using the MRL

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Royal Marsden Hospital

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

A

Alison Tree, MBBS

CONTACT

R

Rosalyne L Westley, MBchB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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