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

NCT01006564 | Unknown

• 1 other identifier: CCR3121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Magnetic Resonance Imaging; Prostate Cancer; Magnetic Resonance Spectroscopy; Radiotherapy planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Interventions

Imaging Investigations (not radiation) OTHER

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 OTHER

Insertion of gold seeds into prostate for image registration.

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dr Nandita deSouza

  CRUK Clinical Magnetic Resonance Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Nandita deSouza

CONTACT

02086613289; nandita.desouza@icr.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 3, 2009

Record last verified: 2009-11

Locations

GB (1)