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MR-simulation in Radiotherapy for Prostate Cancer (FIMRA-P)

Primary Purpose

Cancer of the PROSTATE

Status

Active

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

MRI scan

About this trial

This is an interventional treatment trial for Cancer of the PROSTATE

Eligibility Criteria

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

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

Sites / Locations

Guy's and St. Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-Simulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Standard Operating Procedure (SOP) for MRI-simulation for prostate patients

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

Clinical Protocol for in-direct MRI planning for prostate

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

Clinical Protocol for direct MRI-only planning for prostate

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

Full Information

NCT ID

NCT03238170

First Posted

March 7, 2017

Last Updated

March 17, 2022

Sponsor

Guy's and St Thomas' NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03238170

Brief Title

MR-simulation in Radiotherapy for Prostate Cancer

Acronym

FIMRA-P

Official Title

An Exploratory Study to Assess the Feasibility of Incorporating MR in the Radiotherapy Pathway of Patients With Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the PROSTATE

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MR-Simulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MRI scan

Intervention Description

MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan

Primary Outcome Measure Information:

Title

Standard Operating Procedure (SOP) for MRI-simulation for prostate patients

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Clinical Protocol for in-direct MRI planning for prostate

Description

Time Frame

6 months

Title

Clinical Protocol for direct MRI-only planning for prostate

Description

Time Frame

18 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Hughes

Organizational Affiliation

Guy's and St Thomas' NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guy's and St. Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE19RT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

MR-simulation in Radiotherapy for Prostate Cancer

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