FIMRA-P: MR-simulation in Radiotherapy for Prostate Cancer

• Sponsor: Guy's and St Thomas' NHS Foundation Trust (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03238170
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 75
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the PROSTATE	Device: MRI scan	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Study to Assess the Feasibility of Incorporating MR in the Radiotherapy Pathway of Patients With Prostate Cancer
• Actual Study Start Date: Mar 1, 2017
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MR-Simulation Patients will have 1 MRI scan appointment, using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan. The MR scan will be performed in the radiotherapy treatment position.	Device: MRI scan; MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan

Outcome Measures

Primary Outcome Measures

1. Standard Operating Procedure (SOP) for MRI-simulation for prostate patients [6 months]

   Write a Standard Operating Procedure (SOP) for MRI-scanning of prostate patients in the radiotherapy treatment position so that their data can be used in the treatment planning for either in-direct or MRI-only planning

Secondary Outcome Measures

1. Clinical Protocol for in-direct MRI planning for prostate [6 months]

   Write a clinical protocol for "in-direct" MRI planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and these are translated onto the co-registered CT scan for treatment planning

2. Clinical Protocol for direct MRI-only planning for prostate [18 months]

   Write a clinical protocol for "direct" MRI-only planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and also for dose calculation and setup verification

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guy's and St. Thomas' NHS Foundation Trust	London		United Kingdom	SE19RT

Sponsors and Collaborators

• Guy's and St Thomas' NHS Foundation Trust

Investigators

• Principal Investigator: Simon Hughes, Guy's and St Thomas' NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guy's and St Thomas' NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT03238170
• Other Study ID Numbers: 215681
• First Posted: Aug 3, 2017
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 18, 2022