NCT02745496

Brief Summary

The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard). The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to the suspicious areas identified by MRI. The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within the prostate gland for guiding biopsies. Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better inform clinicians and patients to improve risk stratification and facilitate decision making on subsequent treatment. Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy, which could obviate the need for multiple biopsies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
603

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable prostate-cancer

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

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

5.7 years

First QC Date

March 4, 2016

Last Update Submit

June 24, 2021

Conditions

Prostate Cancer

Keywords

Image-guided biopsyTumour detectionDiagnosticBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen

    Number of prostate cancers detected by MP-MRI when compared to gold standard

    5 years from first recruitment

  • Number of clinically significant cancers detected by MP-MRI when compared to gold standard prostatectomy specimen

    The definition of clinically significant disease will be based on the pathologic assessment of radical prostatectomy (RP) specimen and will include the presence of any the following three prognostic factors: o Gleason grade \>= 7 with pattern 4 or/and 5 Maximum cancer focus size more than 6mm measured in the axial plane Presence of extracapsular extension (ECE)

    5 years from first recruitment

Secondary Outcomes (4)

  • Number of cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)

    5 years from first recruitment

  • Number of significant cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)

    5 years from first recruitment

  • Safety outcomes(death, post biopsy pain, bleeding, sepsis and hospitalization) of intervention (biopsy) in each of the two randomised groups.

    4 years from first recruitment

  • Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology to facilitate analysis of diagnostic accuracy of MRI in men suspected with target condition.

    5 years from first recruitment

Study Arms (2)

TRUS Biopsy

OTHER

Standard of Care Treatment

Procedure: TRUS Biopsy

TRUS/FUSION Biopsy

OTHER

Interventional Treatment

Procedure: TRUS/FUSION Biopsy

Interventions

TRUS BiopsyPROCEDURE

Standard of Care Treatment

TRUS Biopsy
TRUS/FUSION BiopsyPROCEDURE

Interventional Treatment

TRUS/FUSION Biopsy

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males between the age of 40-75 at referral
  • With at least 10 years life expectancy
  • With clinically localised PCa: Prostate Specific Antigen (PSA) ≤20 ng/ml
  • And/or abnormal Digital Rectal Examination (DRE) but \< T3 disease
  • Ability to informed consent

You may not qualify if:

  • Unable to give informed consent
  • Prior prostatic biopsy within 12 months
  • Contraindications to biopsy
  • Poor general health and life expectancy \< 10 years
  • Previous diagnosis of acute prostatitis within 12 months
  • History of prostate cancer
  • Prior transurethral prostatectomy
  • Contraindications to MRI (cardiac pacemakers, allergic reaction to gadolinium based contrast, renal function with baseline eGRF 30 ml/min, intracranial clips, claustrophobia)
  • Previous hip replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninewells Hospital and Medical School

Dundee, Tayside, DD5 4NT, United Kingdom

Location

Related Publications (2)

  • Wei C, Szewczyk-Bieda M, Bates AS, Donnan PT, Rauchhaus P, Gandy S, Ragupathy SKA, Singh P, Coll K, Serhan J, Wilson J, Nabi G. Multicenter Randomized Trial Assessing MRI and Image-guided Biopsy for Suspected Prostate Cancer: The MULTIPROS Study. Radiology. 2023 Jul;308(1):e221428. doi: 10.1148/radiol.221428.

    PMID: 37489992DERIVED

  • Szewczyk-Bieda M, Wei C, Coll K, Gandy S, Donnan P, Ragupathy SKA, Singh P, Wilson J, Nabi G. A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol. Trials. 2019 Nov 21;20(1):638. doi: 10.1186/s13063-019-3746-0.

    PMID: 31752954DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ghulam Nabi

    University of Dundee

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Surgical Uro-oncology

Study Record Dates

First Submitted

March 4, 2016

First Posted

April 20, 2016

Study Start

December 1, 2014

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)