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

NCT00230386 | Completed Phase 1

• 1 other identifier: UHN REB 03-0272-CE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy

Interventions

MRI DEVICE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Not suitable for MRI scan
• Previous reaction to gadolinium
• Impaired renal function
• Inability to give informed consent

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

University Health Network Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

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

• Michael Milosevic, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: May 1, 2003
• Last Updated: July 14, 2009

Record last verified: 2005-09

Locations

CA (1)