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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MR LINAC
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring MR GUIDED RADIOTHERAPY

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Marsden - SurreyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR LINAC RADIOTHERAPY

Arm Description

RADIOTHERAPY DELIVERED ON MR LINAC

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2018
Last Updated
September 5, 2018
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03658525
Brief Title
Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)
Acronym
PRISM
Official Title
Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
MR GUIDED RADIOTHERAPY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To assess delivery of prostate IMRT on the MR linac
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR LINAC RADIOTHERAPY
Arm Type
Experimental
Arm Description
RADIOTHERAPY DELIVERED ON MR LINAC
Intervention Type
Device
Intervention Name(s)
MR LINAC
Intervention Description
MR GUIDED PROSATE RADIOTHERAPY
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 YEARS

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
INVOLVES PROSTATE CANCER PATIENTS SO MUST BE MALE
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALISON TREE
Phone
02086613269
Email
ALISON.TREE@RMH.NHS.UK
Facility Information:
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-8661-3388

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
ANONYMISED DATA WILL BE SHARED WITHIN THE ELEKTA CONSORTIUM

Learn more about this trial

Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)

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