Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma

NCT ID: NCT00230386

Last Updated: 2009-07-14

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Brief Summary

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This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. All subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. The objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on MRI at these sites.

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MRI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Previously have had radical radiotherapy for localised prostate cancer
* Due to undergo routine post-treatment prostatic biopsies
* Suitable for MRI scan
* Adequate renal function
* No previous reaction to gadolinium
* Able to give informed consent
* No recent prostate biopsy within 6 weeks of enrolment
* Performance status (Eastern Cooperative Oncology Group \[ECOG\]) 0 or 1

Exclusion Criteria

* Not suitable for MRI scan
* Previous reaction to gadolinium
* Impaired renal function
* Inability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Michael Milosevic, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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University Health Network Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 03-0272-CE

Identifier Type: -

Identifier Source: org_study_id

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