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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01006564 |
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Date of registration:
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02/11/2009 |
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Primary sponsor: |
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Public title:
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Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer
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Scientific title:
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Multifunctional MR for Radiotherapy Planning in Prostate Cancer |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01006564 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Dr Nandita deSouza |
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Address:
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Telephone:
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02086613289 |
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Email:
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nandita.desouza@icr.ac.uk |
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Affiliation:
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Name:
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Dr Nandita deSouza |
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Address:
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Telephone:
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Email:
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Affiliation:
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CRUK Clinical Magnetic Resonance Research Group |
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Key inclusion & exclusion criteria
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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).
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Other: Imaging Investigations (not radiation)
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Other: Other
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Primary Outcome(s)
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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).
[Time Frame: No]
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Secondary Outcome(s)
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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.
[Time Frame: No]
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Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.
[Time Frame: No]
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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.
[Time Frame: No]
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Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.
[Time Frame: No]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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