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MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00775866
Collaborator
U.S. Army Medical Research and Development Command (U.S. Fed), Princess Margaret Hospital, Canada (Other)
82
Enrollment
1
Location
1
Arm
131.5
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: MRI-Guided Biopsy
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
N/A
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
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Sep 15, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. The primary endpoint is a preliminary estimate of the diagnostic accuracy of MRI in identifying sites of recurrent tumor after radiotherapy for prostate cancer. [at the end of the evaluation phase]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Health Network Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto
  • U.S. Army Medical Research and Development Command
  • Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Peter Chung, MB ChB, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00775866
Other Study ID Numbers:
  • UHN REB 05-0641-C
  • Proposal Number PC050204
  • Award Number W81XWH-05-1-0570
First Posted:
Oct 20, 2008
Last Update Posted:
Nov 29, 2017
Last Verified:
Nov 1, 2017
Keywords provided by University Health Network, Toronto
prostate cancer, magnetic resonance imaging, guided imagery
Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence

Study Results

No Results Posted as of Nov 29, 2017