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

NCT ID: NCT01006564

Last Updated: 2009-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Interventions

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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.

Intervention Type OTHER

Other

Insertion of gold seeds into prostate for image registration.

Intervention Type OTHER

Eligibility 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).
Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Institute of Cancer Research

Principal Investigators

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Dr Nandita deSouza

Role: PRINCIPAL_INVESTIGATOR

CRUK Clinical Magnetic Resonance Research Group

Locations

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Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dr Nandita deSouza

Role: CONTACT

02086613289

Other Identifiers

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CCR3121

Identifier Type: -

Identifier Source: org_study_id

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