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MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775866
First Posted: October 20, 2008
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
U.S. Army Medical Research and Materiel Command
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
  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: None (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:


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 ]

Enrollment: 82
Study Start Date: October 2006
Study Completion Date: September 15, 2017
Primary Completion Date: May 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775866


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
U.S. Army Medical Research and Materiel Command
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Peter Chung, MB ChB University Health Network, Toronto
  More Information

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00775866     History of Changes
Other Study ID Numbers: UHN REB 05-0641-C
Proposal Number PC050204
Award Number W81XWH-05-1-0570
First Submitted: October 16, 2008
First Posted: October 20, 2008
Last Update Posted: November 29, 2017
Last Verified: November 2017

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