NCT02936258

Brief Summary

The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of prostate cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

5 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 22, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

September 28, 2016

Last Update Submit

February 20, 2018

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • MRI-The proportion of men with clinically significant cancer (Gleason > 7)

    To determine whether the proportion of men with clinically significant cancer (Gleason \> 7) detected by MRI-targeted biopsy is no less than systematic TRUS guided biopsy.

    1 year

Secondary Outcomes (6)

  • Biopsy-The proportion of men with clinically significant cancer (Gleason ≥7)

    1 year

  • Proportion of men in each arm with clinically insignificant cancer

    1 year

  • Proportion of men in each arm with Gleason >4+3 detected.

    1 year

  • Proportion of men in MRI arm who avoid biopsy.

    1 year

  • Proportion of men in the MRI arm whom the PI-RADS score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected.

    1 year

  • +1 more secondary outcomes

Study Arms (2)

MRI

OTHER

Men in Arm A will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. The unbiopsied men will have a repeat MRI at 2 years.

Procedure: MRIProcedure: MRI Targeted Biopsy

Standard of Care

ACTIVE COMPARATOR

Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).

Procedure: Standard of Care

Interventions

Standard of CarePROCEDURE

Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).

Standard of Care
MRIPROCEDURE

Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.

MRI
MRI Targeted BiopsyPROCEDURE

Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.

MRI

Eligibility Criteria

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

You may qualify if:

  • Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy;
  • ≥5% chance of high-grade prostate cancer as calculated using individualized risk assessment of prostate cancer calculator, PCPTRC 2.0, found at http://deb.uthscsa.edu/URORiskCalc/Pages/calcs.jsp;
  • Serum PSA ≤ 20ng/ml within 3 months of randomization
  • Fit to undergo all procedures listed in protocol;
  • Able to provide written informed consent.

You may not qualify if:

  • Prior prostate biopsy
  • Prior treatment for prostate cancer
  • Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
  • Contraindication to prostate biopsy
  • Men in whom artifact would reduce the quality of the MRI, i.e. previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
  • Unfit to undergo any procedures listed in protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z1M9, Canada

NOT YET RECRUITING

London Health Sciences Centre-Victoria Hospital

London, Ontario, N6A5W9, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G1X6, Canada

RECRUITING

CIUSSS du Centre-Ouest-de-I'ile-de-Montreal-Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

RECRUITING

Related Publications (2)

  • Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Machado A, Levental M, Ghai S, Chang SD, Patel C, Kassam Z, Loblaw A, Kebabdjian M, Pond G, Haider MA. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of a Prospective Randomized Trial (PRECISE). Eur Urol Oncol. 2024 Jun;7(3):456-461. doi: 10.1016/j.euo.2023.09.013. Epub 2023 Oct 12.

    PMID: 37838556DERIVED

  • Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Bladou F, Mercado A, Levental M, Ghai S, Chang SD, Milot L, Patel C, Kassam Z, Moore C, Kasivisvanathan V, Loblaw A, Kebabdjian M, Earle CC, Pond GR, Haider MA. Comparison of Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy for Biopsy-Naive Men at Risk for Prostate Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):534-542. doi: 10.1001/jamaoncol.2020.7589.

    PMID: 33538782DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Laurence Dr Klotz, MD

CONTACT

416-480-4673laurence.klotz@sunnybrook.ca

Marlene Kebabdjian

CONTACT

416-480-6100marlene.kebabdjian@sunnybrook.ca

Study Design

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

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 18, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

February 22, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Plan to share publication

Locations

CA(5)