Improving Prostate Cancer Detection Using MRI-Targeted TRUS-Guided Biopsy

NCT02488096 | Completed

• 1 other identifier: REB15-27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Clinically Significant Cancer Detection (Biopsy)

  * max core length \>=3mm (Epstein criteria) * Gleason score \>=3+4 (Epstein criteria) * clinical Stage T2c (D'Amico criteria) * Gleason score 6 with \>50% involvement of prostate

  participants will be followed until diagnosis, an expected average of 2 weeks

Secondary Outcomes (5)

• Clinically Significant Cancer Detection (Prostatectomy)

  Up to 6 months after enrollment

• Proportion of Men Who Could Have Potentially Avoided Biopsy

  participants will be followed until diagnosis, an expected average of 2 weeks

• Proportion of Cancers Correctly Identified by MRI

  participants will be followed until diagnosis, an expected average of 2 weeks

• Proportion of Cancers that would have been Missed

  participants will be followed until diagnosis, an expected average of 2 weeks

• Estimated difference in cost

  participants will be followed until diagnosis, an expected average of 2 weeks

Study Arms (2)

TRUS-Guided Biopsy

ACTIVE COMPARATOR

Transrectal Ultrasound (TRUS)-guided biopsy systematic 12-core biopsy (standard care)

Device: TRUS-Guided Biopsy

MRI + TRUS-Guided biopsy

EXPERIMENTAL

Prostate MRI later followed by systematic 12-score TRUS-guided biopsy + targeted biopsy of additional MRI-detected scores.

Device: MRI + TRUS-Guided Biopsy

Interventions

TRUS-Guided Biopsy DEVICE

The standard care TRUS-guided biopsy is a schematic 12 core biopsy scheme with 2 cores taken from each of standard 6 zones. In some cases, the radiologist may take additional cores beyond 12 if suspicious areas are suspected from clinical findings or TRUS. TRUS-guided biopsies will be performed by a designated group of radiologists. An overall score out of 5 of likelihood of clinically significant prostate cancer will be recorded for each individual patient. The biopsy will be scheduled within 1 week of referral.

Also known as: Transrectal Ultrasound Guided Biopsy

TRUS-Guided Biopsy

MRI + TRUS-Guided Biopsy DEVICE

A designated radiologist will perform all MRI exams. The radiologist will identify locations of the prostate gland of the standard 12 cores to be taken and any additional lesions deemed to be suspicious for cancer. The procedure for the MRI-targeted biopsy will be exactly the same as the TRUS-guided biopsy except that an additional 2 cores per area may be taken beyond the standard 12 cores in areas that were previously identified by MRI on the map. The systematic 12-core biopsy will always be performed first. The radiologist performing the MRI-targeted biopsy will review the MRI targets prior to the biopsy as per standard of care, and he/she will also perform the TRUS-guided biopsies for this group. Patients will be scheduled for their biopsy \~ 1 week after the MRI.

Also known as: Magnetic Resonance Imaging + MRI-Targeted TRUS-guided Biopsy

MRI + TRUS-Guided biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for an ultrasound-guided prostate biopsy
• Indication 1: Men without a history of prostate cancer referred to the PAC for a biopsy who have a history of 1 negative biopsy who are being referred for a follow-up biopsy
• Indication 2: Men who have a history of diagnosis of prostate cancer and are currently on active surveillance under the care of an oncologist who are referred to the PAC for a follow-up biopsy

You may not qualify if:

• Are unable to consent on their own behalf
• Less than 3 months since previous biopsy (to avoid inflammation and hemorrhage confounding MRI image)
• A history of treatment for prostate cancer (including surgery, chemotherapy or radiotherapy)
• Emergent/urgent biopsy referrals
• History of urinary tract infections or prostatitis in the last 3 months
• Contraindications to MRI:
• Ferromagnetic or otherwise non-MRI compatible aneurysm clips
• The presence of an implanted pacemaker or implanted defibrillator device
• Contraindication to receiving Gadolinium containing contrast for the which may include past or current kidney disease or injury or kidney transplant
• Severe claustrophobia

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead

Study Sites (1)

Regina Qu'Appelle Health Region

Regina, Saskatchewan, S4S0A5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jennifer St. Onge, PhD

  Research, Regina Qu'Appelle Health Region

  PRINCIPAL INVESTIGATOR

• Ashok Verma, MB

  Radiology, Regina Qu'Applle Health Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 2, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)