MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy - Full Text View

Sponsor:	University Health Network, Toronto
Collaborator:	U.S. Army Medical Research and Materiel Command
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00775866

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:

MedlinePlus related topics: Cancer MRI Scans Prostate Cancer

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 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Investigators

Principal Investigator:

Cynthia Ménard, MD

University Health Network, Toronto

More Information

No publications provided

Responsible Party:	Dr. Cynthia Ménard, Clinician Scientist, Staff Radiation Oncologist, University Health Network (Princess Margaret Hospital)
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:	February 11, 2011
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 February 12, 2012