Dose De-escalation in Prostate Radiotherapy Using the MRL

NCT05709496 | Recruiting DMC

• 1 other identifier: CCR5715
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Adenocarcinoma

Keywords

Intermediate risk

Outcome Measures

Primary Outcomes (1)

• The technical ability to treat prostate cancer with escalated dose to the gross tumour volume tumour and de-escalated dose to the normal prostate the Unity MR-linac.

  The primary end point is defined by coverage of GTV4mm D90% \>42Gy on the post-treatment imaging.

  2 years

Secondary Outcomes (4)

• Acute toxicity

  2 years

• Late toxicity

  2 years

• Patient-reported outcomes

  2 years

• Biochemical control

  2 years

Study Arms (1)

De-escalated radiotherapy to the prostate

EXPERIMENTAL

De-escalated radiotherapy to the prostate with an intra-prostatic boost to the dominant .

Radiation: De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac

Interventions

De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac RADIATION

30 Gy in 5 fractions to the whole prostate with 45 Gy in 5 fractions to the dominant lesion

De-escalated radiotherapy to the prostate

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This is a feasibility study in men with intermediate risk prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Central Study Contacts

Alison Tree, MBBS

CONTACT

02086613269; alison.tree@icr.ac.uk

Rosalyne L Westley, MBchB

CONTACT

07731300755; rosalyne.westley@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An R-IDEAL stage 2a study aiming to demonstrate technical feasibility and establish likely toxicity rates for powering the subsequent study. Men will receive de-escalated radiotherapy to the prostate with a boost to the dominant lesion.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 2, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 5 years
• Access Criteria: Must have approved access from the site sponsor.

Locations

GB (1)