A Feasibility Study of Dose De-escalation in Prostate Radiotherapy Using the Magnetic Resonance Linear Accelerator (MRL)

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
The Royal Marsden Hospital
RECRUITING
Sutton
Contact Information
Primary
Alison Tree, MBBS
alison.tree@icr.ac.uk
02086613269
Backup
Rosalyne L Westley, MBchB
rosalyne.westley@rmh.nhs.uk
07731300755
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 20
Treatments
Experimental: De-escalated radiotherapy to the prostate
De-escalated radiotherapy to the prostate with an intra-prostatic boost to the dominant .
Related Therapeutic Areas
Sponsors
Leads: Royal Marsden NHS Foundation Trust

This content was sourced from clinicaltrials.gov