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Completed

NCT Number: NCT02745496

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

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.

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Key information

Conditions

Prostate Cancer Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ninewells Hospital and Medical School

Dundee, Tayside, DD5 4NT, United Kingdom

About this study

There is preliminary evidence suggesting that MultiParametric Magnetic Resonance Imaging (MP-MRI) can be a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Gleason grade (GG) is a critical predictor of the aggressiveness of PCa, but in up to one in three men, the histology of radical prostatectomy specimens is different from the histology of Transrectal Ultrasound (TRUS)-guided biopsies. This discrepancy contributes to- and is a sign of- poor risk stratification of men with localised PCa.

The research aims to answer the following questions:

  • Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI?
  • How reliable is pre-biopsy MP-MRI in correctly predicting aggressive disease?

The investigators envisage that MP-MRI information will reduce unnecessary biopsies and over-detection of indolent PCa, while improving the detection of aggressive disease.

Primary Objectives

  • To determine whether using MP-MRI can improve cancer detection and characterization of prostate cancer

Secondary Objectives

  • To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative biopsies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

TRUS Biopsy

Procedure

Standard of Care Treatment

TRUS/FUSION Biopsy

Procedure

Interventional Treatment

Primary outcomes

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

    Time frame: 5 years from first recruitment

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

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

    Time frame: 5 years from first recruitment

    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)

Secondary outcomes

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

    Time frame: 5 years from first recruitment

    Number of cancer detected in each randomised group

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

    Time frame: 5 years from first recruitment

    Number of significant cancer detected in each randomised group

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

    Time frame: 4 years from first recruitment

    Number of participants with deaths, side effects (post biopsy pain, bleeding, sepsis and hospitalization) in each of the two randomised groups.

  4. 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.

    Time frame: 5 years from first recruitment

    Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • Health Informatics Centre
  • NHS Tayside
  • Prostate Cancer UK
  • Tayside Clinical Trials Unit

Registry information

Official study title

Multiparametric Magnetic Resonance Imaging Characterization and Guided Biopsy of the Prostate in Men Suspected of Having Prostate Cancer

Acronym: MULTIPROS

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2016
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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