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

Prostate Cancer Clinical Trial

Official title:

Multifunctional MR for Radiotherapy Planning in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01006564
• Other study ID #: CCR3121
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2009
• Last updated: November 2, 2009
• Start date: March 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr Nandita deSouza
• Phone: 02086613289
• Email: nandita.desouza[@]icr.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Imaging Investigations (not radiation)
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.
• Other
Insertion of gold seeds into prostate for image registration.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).			No
Secondary	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.			No
Secondary	Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.			No
Secondary	Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.			No
Secondary	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.			No