Clinical trial NCT03658525: Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)
Official title: Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: MR GUIDED RADIOTHERAPY
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To assess delivery of prostate IMRT on the MR linac
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 2 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
Study officials:
References: