NCT02380027

Brief Summary

This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests. We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2016

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

First Submitted

Initial submission to the registry

February 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

February 23, 2015

Last Update Submit

April 30, 2018

Conditions

Prostate Neoplasm

Keywords

Prostate biopsyMRItransrectalDetection

Outcome Measures

Primary Outcomes (1)

  • Proportion of men with clinically significant detected

    When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcomes (9)

  • Proportion of men in MRI arm who avoid biopsy

    When MRI results available, at an expected average of 30 days post-MRI

  • Proportion of men with MRI score 3, 4 or 5 who have no clinically significant cancer detected

    When histology results available, at an expected average of 30 days post-biopsy

  • Proportion of men who go on to definitive treatment for prostate cancer

    After treatment decision, at an expected average of 30 days post-biopsy

  • Cancer core length of the most involved biopsy core (maximum cancer core length)

    When histology results available, at an expected average of 30 days post-biopsy

  • Proportion of men with post-biopsy adverse events

    30 days post biopsy

  • +4 more secondary outcomes

Study Arms (2)

MRI-arm

EXPERIMENTAL

Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken.

Device: MRIProcedure: MRI-targeted biopsy

TRUS-biopsy arm

ACTIVE COMPARATOR

Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy

Procedure: TRUS-biopsy

Interventions

MRIDEVICE

This will be a multi-parametric MRI of the prostate

MRI-arm
MRI-targeted biopsyPROCEDURE

This will be a biopsy targeted to suspicious areas on the MRI

MRI-arm
TRUS-biopsyPROCEDURE

This will be a standard 12 core trans-rectal prostate biopsy

TRUS-biopsy arm

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
  • Serum PSA ≤ 20ng/ml within the previous 3 months
  • Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
  • 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 glomerular filtration rate ≤ 50mls/min)
  • Contraindication to prostate biopsy
  • Men in whom artifact would reduce the quality of the MRI
  • 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 (1)

University College Hospitals

London, United Kingdom

Location

Related Publications (2)

  • Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.

    PMID: 29552975DERIVED

  • Kasivisvanathan V, Jichi F, Klotz L, Villers A, Taneja SS, Punwani S, Freeman A, Emberton M, Moore CM. A multicentre randomised controlled trial assessing whether MRI-targeted biopsy is non-inferior to standard transrectal ultrasound guided biopsy for the diagnosis of clinically significant prostate cancer in men without prior biopsy: a study protocol. BMJ Open. 2017 Oct 12;7(10):e017863. doi: 10.1136/bmjopen-2017-017863.

    PMID: 29025845DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Caroline Moore, MD FRCS

    University College Hospital London and University College London

    STUDY CHAIR

  • Mark Emberton, MD FRCS

    University College Hospital London and University College London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 5, 2015

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

GB(1)