Back to resultsMultifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Imaging Investigations (not radiation)
Other
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Magnetic Resonance Imaging, Prostate Cancer, Magnetic Resonance Spectroscopy, Radiotherapy planning
Eligibility Criteria
Inclusion Criteria:
- Hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression
- Patients with low-high risk histologically confirmed localised disease are eligible, with WHO performance status 0-1.
Exclusion Criteria:
- Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).
- No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy <10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).
Sites / Locations
- Royal Marsden NHS Foundation TrustRecruiting
Outcomes
Primary Outcome Measures
Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP).
Secondary Outcome Measures
Comparison of reproducibility of registration algorithms for mapping functional MR data acquired before hormone therapy to MR anatomical data acquired after hormone therapy and prior to radiotherapy.
Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.
Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.
Comparison of dose distributions produced by rival radiotherapy plans judged using three standard dose-volume constraints for targets and normal tissues and careful examination of the 3D dose distribution.
Full Information
NCT ID
NCT01006564
First Posted
November 2, 2009
Last Updated
November 2, 2009
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Institute of Cancer Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01006564
Brief Title
Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer
Official Title
Multifunctional MR for Radiotherapy Planning in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Institute of Cancer Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Magnetic Resonance Imaging, Prostate Cancer, Magnetic Resonance Spectroscopy, Radiotherapy planning
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Imaging Investigations (not radiation)
Intervention Description
Pre-hormone therapy MRI scans will be performed as an adjunct to the patients' staging MRI scan; post hormone MRI will be done wholly for research purposes.
Intervention Type
Other
Intervention Name(s)
Other
Intervention Description
Insertion of gold seeds into prostate for image registration.
Primary Outcome Measure Information:
Title
Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP).
Secondary Outcome Measure Information:
Title
Comparison of reproducibility of registration algorithms for mapping functional MR data acquired before hormone therapy to MR anatomical data acquired after hormone therapy and prior to radiotherapy.
Title
Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.
Title
Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.
Title
Comparison of dose distributions produced by rival radiotherapy plans judged using three standard dose-volume constraints for targets and normal tissues and careful examination of the 3D dose distribution.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression
Patients with low-high risk histologically confirmed localised disease are eligible, with WHO performance status 0-1.
Exclusion Criteria:
Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).
No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy <10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Nandita deSouza
Phone
02086613289
Email
nandita.desouza@icr.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Nandita deSouza
Organizational Affiliation
CRUK Clinical Magnetic Resonance Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer
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