Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study) (PRISM)

Currently radiotherapy for prostate cancer is directed using scans or X-Rays, which ensures the radiotherapy treatment 'hits the target' and avoids the healthy tissues around the prostate. There are two current methods of radiotherapy image guidance- either placing small gold seeds into the prostate and taking XRays or doing a small CT scan of the prostate region each day. Neither of these methods are perfect and have drawbacks and inaccuracies.

The best way to see the prostate is with an MRI scan - this shows the edge of the prostate much more clearly and can even show the area of most aggressive cancer within the prostate. Shortly the investigators will have the ability to use a new machine - an MR-Linac - which combines an MR scanner and a radiotherapy machine.

As well as giving the investigators a clearer picture, and enabling the investigators to keep watching the prostate while the participant has their treatment (not currently possible with standard machines) this new machine will also allow the investigators to change the radiotherapy plan if they can see that the internal anatomy has shifted day to day. Currently the investigators have to give the same radiotherapy plan each day, which means the investigators have to treat a 'safety margin' around to prostate to allow for these day to day anatomy changes (e.g. rectal filling).

The aim of this study is to assess the technical feasibility of delivering radical radiotherapy for prostate cancer using the MR-Linac, including the feasibility of changing the radiotherapy plan on a daily basis to mirror internal anatomy changes. The investigators will recruit 30 patients with localised prostate cancer who need radiotherapy. The team will deliver the same dose in the same number of days i.e. the same as standard radiotherapy. Side effects will also be assessed by physicians and using patient questionnaires.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: MR LINAC

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ALISON TREE; Phone Number: 02086613269; Email: ALISON.TREE@RMH.NHS.UK

Study Locations

• United Kingdom
  • England
    • Sutton, England, United Kingdom, SM2 5PT
      • Recruiting
      • Royal Marsden - Surrey
      • Contact: Contact Person; Phone Number: 44-20-8661-3388

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

All of the following criteria should be met for study entry.

• Histologically confirmed adenocarcinoma prostate- grade group 3 or less (Gleason 4+3=7 or less).
• Staging T2-T3a,N0M0 (MRI or DRE staging allowed).
• PSA<25.
• 6 months short course androgen deprivation therapy allowed, not mandated.
• Maximum prostate volume 70cc.
• IPSS <12 at baseline.
• WHO performance status 0 or 1.
• Written informed consent.

Exclusion Criteria:

If one of the following criteria are met, the patient is not eligible for the study

• Other invasive malignancy within the last two years- excluding basal cell carcinoma and squamous cell carcinoma of the skin.
• Patients who, in the opinion of the Local PI, require long course (> 6 months) ADT.
• Contraindications to MRI.Including pacemaker, implanted devices, any non-MR compatible metallic implants.Severe claustrophobia.
• Contraindications to gold fiducial marker implantation.Clotting disorders, very high risk of bleeding.Clinically unacceptable risk of temporarily stopping anticoagulation or antiplatelet medications.
• Contraindications to prostate radiotherapy,Previous pelvic radiotherapy.Clinically significant inflammatory bowel disease.
• Bilateral or single hip replacements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MR LINAC RADIOTHERAPY; RADIOTHERAPY DELIVERED ON MR LINAC	Device: MR LINAC; MR GUIDED PROSATE RADIOTHERAPY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients in whom the imaging and treatment on the MR Linac (i.e. total time on the treatment couch) can be completed within 1 hour on 90% of fractions as assessed by the radiotherapy timing sheet.	The radiotherapy timing sheet will be used to record the length of time for patients to have their MR guided adaptive radiotherapy for each fraction. This information will then inform if treatment can be given in a clinically feasible time frame.	2 YEARS

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: MR GUIDED RADIOTHERAPY
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CCR4888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: ANONYMISED DATA WILL BE SHARED WITHIN THE ELEKTA CONSORTIUM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No