MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy

NCT ID: NCT00775866

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2017-09-15

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.

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.

Conditions

Recurrent Prostate Cancer

Keywords

prostate cancer, magnetic resonance imaging, guided imagery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRI guided prostate biopsy

Group Type: EXPERIMENTAL

MRI-Guided Biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Chung, MB ChB

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 25203127 (View on PubMed)

Other Identifiers

Proposal Number PC050204

Identifier Type: -

Identifier Source: secondary_id

Award Number W81XWH-05-1-0570

Identifier Type: -

Identifier Source: secondary_id

UHN REB 05-0641-C

Identifier Type: -

Identifier Source: org_study_id