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MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy

This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00775866
First received: October 16, 2008
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

In this study we will test a new procedure to guide needle biopsies into the prostate gland based on MRI. This study will be conducted in patients who may have recurrence of their cancer in the prostate gland after radiation therapy in order to map out the location of the recurrence. Using this technique, we will be able to measure the accuracy of MR images in identifying the site of tumour recurrence.


Condition Intervention
Recurrent Prostate Cancer
 Procedure: MRI-Guided Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MRI - Guided Biopsy for Suspicion of Locally Recurrent Prostate Cancer After External Beam Radiotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The primary endpoint is a preliminary estimate of the diagnostic accuracy of MRI in identifying sites of recurrent tumor after radiotherapy for prostate cancer. [ Time Frame: at the end of the evaluation phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2006
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI guided prostate biopsy Procedure: MRI-Guided Biopsy
Technical development and clinical testing of a novel technique for magnetic resonance imaging (MRI) guided prostate biopsy in a 1.5T horizontal bore scanner using a dedicated interventional table.

Detailed Description:

This study involves the technical development and clinical testing of a novel technique for magnetic resonance imaging (MRI) guided prostate biopsy in a 1.5T horizontal bore scanner using a dedicated interventional table. We primarily hypothesize that the integration of diagnostic and interventional MRI enables needle biopsy targeting to foci of tumor recurrence after radiotherapy, and will enable a determination of the diagnostic accuracy of MRI in mapping sub-sites of tumor recurrence after radiotherapy. RELEVANCE TO PUBLIC HEALTH: Patients with recurrence of their prostate cancer after radiotherapy currently face difficult choices. Standard second line treatments target the entire prostate gland and are associated many side effects. This study will directly improve the detection, spatial delineation, and characterization of prostate cancer persistence after radiotherapy. If anatomic patterns of disease persistence are found across patients, radiation delivery techniques will be suitably modified, which may translate to improved cure rates. Importantly, this study will establish a procedural platform for MRI-guidance of minimally invasive local salvage therapies. By precisely focusing salvage therapy to sites of tumor persistence within the prostate gland, side effects may be reduced in the future.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biochemical failure > 18 months after definitive external beam radiotherapy (ASTRO definition - revised version 2006: rise by 2 ng/mL or more above the nadir PSA)
  • PSA <20 prior to initial course of external beam radiotherapy
  • PSADT >3 months at failure
  • Age ≥ 18 years
  • ECOG performance status 0 or 1 with >10 year life expectancy
  • Fit for local anaesthesia
  • Informed consent:

Exclusion Criteria:

  • Contraindications to MRI
  • Severe claustrophobia
  • Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding brachytherapy
  • Previous brachytherapy
  • Active hormonal therapy
  • Radiologic evidence of LN or distant metastases
  • Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy.
  • Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
  • Contraindications to conscious sedation
  • Contraindication to IV Gadolinium administration
  • latex allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775866

Contacts
Contact: Cynthia Ménard, MD 416 946-6513 cynthia.menard@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Cynthia Ménard, MD            
Sponsors and Collaborators
University Health Network, Toronto
U.S. Army Medical Research and Materiel Command
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Cynthia Ménard, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00775866     History of Changes
Other Study ID Numbers: 05-0641-C, Proposal Number PC050204, Award Number W81XWH-05-1-0570
Study First Received: October 16, 2008
Last Updated: December 20, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
prostate cancer, magnetic resonance imaging, guided imagery

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013