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Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer

NCT02745496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2021-06-25

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

TRUS Biopsy

Standard of Care Treatment

PROCEDURE

TRUS/FUSION Biopsy

Interventional Treatment

Sponsors & Collaborators

  • NHS Tayside

    collaborator OTHER_GOV

  • Prostate Cancer UK

    collaborator OTHER

  • Tayside Clinical Trials Unit

    collaborator UNKNOWN

  • Health Informatics Centre

    collaborator UNKNOWN

  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV

  • University of Dundee

    lead OTHER

Principal Investigators

  • Ghulam Nabi · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2020-08-31
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02745496 on ClinicalTrials.gov