Clinical trial NCT03238170: MR-simulation in Radiotherapy for Prostate Cancer
Official title: An Exploratory Study to Assess the Feasibility of Incorporating MR in the Radiotherapy Pathway of Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of the PROSTATE
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy planning systems, so that it can be potentially used to reduce healthy tissue exposure to radiation. Subsequently, the protocols and procedures established can be used to put the technique into routine clinical practice.

Detailed description: Conventional radiotherapy treatment planning uses computed tomography (CT) scans to provide an accurate 3-D picture of the local anatomy. This helps the planners to maximise the radiation dose delivered to the prostate, whilst minimising the dose to surrounding normal tissue. Magnetic resonance imaging (MRI) scanning is an established diagnostic imaging technique that provides even clearer images of the local anatomy. However, until recently the technology hasn't existed to allow us to perform MRI scans with patients "set-up" in the position required to plan and deliver radiotherapy to the prostate. This study is being performed to assess methods that may allow us to incorporate MRI scans into the radiotherapy planning process, which may further increase the accuracy of the treatment, reducing the irradiation of surrounding normal tissue and minimising toxicity.

Eligibility criteria: Inclusion Criteria:

* Written, voluntary, informed consent
* Age ≥ 18
* ECOG Performance Status ≤ 2
* Life expectancy \> 12 months
* Histologically proven carcinoma of the prostate
* Radical radiotherapy +/- hormones indicated as the primary treatment modality
* Staging diagnostic MRI of the prostate need to be available for comparison.
* Adequate organ function and absence of other major concurrent illness, allowing

Exclusion Criteria:

* Inability to provide informed consent
* Impaired renal function (serum creatinine of \> 200)
* Severely impaired liver function
* Patients with allergies or contra-indications to the gadolinium contrast agent that may be used in the study
* Severe claustrophobia or inability to tolerate MRI scans
* General contra-indications to MRI including cardiac pacemakers and defibrillators, metallic prosthetic devices, aneurysm clips and metal fragments in the eyes, as defined in MRI safety departmental protocols
* Serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study
* Any patient who has urinary or faecal incontinence
* Status greater than or equal to 3

Primary outcomes:
measure: Standard Operating Procedure (SOP) for MRI-simulation for prostate patients
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Protocol for in-direct MRI planning for prostate
timeFrame: 6 months
measure: Clinical Protocol for direct MRI-only planning for prostate
timeFrame: 18 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Simon Hughes
role: PRINCIPAL_INVESTIGATOR
References: