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

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ClinicalTrials.gov Identifier: NCT03658525
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Device: MR LINAC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: To assess delivery of prostate IMRT on the MR linac
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MR LINAC RADIOTHERAPY
RADIOTHERAPY DELIVERED ON MR LINAC
Device: MR LINAC
MR GUIDED PROSATE RADIOTHERAPY




Primary Outcome Measures :
  1. 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. [ Time Frame: 2 YEARS ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   INVOLVES PROSTATE CANCER PATIENTS SO MUST BE MALE
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658525


Contacts
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Contact: ALISON TREE 02086613269 ALISON.TREE@RMH.NHS.UK

Locations
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United Kingdom
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person    44-20-8661-3388      
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03658525     History of Changes
Other Study ID Numbers: CCR4888
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: ANONYMISED DATA WILL BE SHARED WITHIN THE ELEKTA CONSORTIUM

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Royal Marsden NHS Foundation Trust:
MR GUIDED RADIOTHERAPY