Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT01006564
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Last Update Submitted: 2009-11-02
• Study First Posted: 2009-11-03
• Last Update Posted: 2009-11-03
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom