Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)

NCT ID: NCT03658525

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2023-08-31

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR LINAC RADIOTHERAPY

RADIOTHERAPY DELIVERED ON MR LINAC

Group Type: EXPERIMENTAL

MR LINAC

Intervention Type: DEVICE

MR GUIDED PROSATE RADIOTHERAPY

Interventions

MR LINAC

MR GUIDED PROSATE RADIOTHERAPY

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Marsden - Surrey

Sutton, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

ALISON TREE

Role: CONTACT

ALISON.TREE@RMH.NHS.UK

02086613269

Facility Contacts

Contact Person

Role: primary

44-20-8661-3388

Other Identifiers

CCR4888

Identifier Type: -

Identifier Source: org_study_id