NCT00775866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

8.6 years

First QC Date

October 16, 2008

Last Update Submit

November 27, 2017

Conditions

Recurrent Prostate Cancer

Keywords

prostate cancer, magnetic resonance imaging, guided imagery

Outcome Measures

Primary Outcomes (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

Study Arms (1)

MRI guided prostate biopsy

EXPERIMENTAL
Procedure: MRI-Guided Biopsy

Interventions

MRI-Guided BiopsyPROCEDURE

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.

MRI guided prostate biopsy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Menard C, Iupati D, Publicover J, Lee J, Abed J, O'Leary G, Simeonov A, Foltz WD, Milosevic M, Catton C, Morton G, Bristow R, Bayley A, Atenafu EG, Evans AJ, Jaffray DA, Chung P, Brock KK, Haider MA. MR-guided prostate biopsy for planning of focal salvage after radiation therapy. Radiology. 2015 Jan;274(1):181-91. doi: 10.1148/radiol.14122681. Epub 2014 Sep 8.

    PMID: 25203127BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Peter Chung, MB ChB

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 20, 2008

Study Start

October 1, 2006

Primary Completion

May 1, 2015

Study Completion

September 15, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

CA(1)