MR-simulation in Radiotherapy for Prostate Cancer

Cancer of the PROSTATE Clinical Trial

— FIMRA-P  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03238170
• Other study ID #: 215681
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the PROSTATE
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	6 months
Secondary	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	18 months