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

University of Dundee

Status

Completed

Conditions

Prostate Cancer

Treatments

Procedure: TRUS Biopsy

Procedure: TRUS/FUSION Biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02745496

MULTIPROS Study

Details and patient eligibility

About

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.

Full description

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.

Enrollment

603 patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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