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

NCT ID: NCT02745496

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 603 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2020-12-31

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.

Detailed 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:

1. Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI?

2. 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRUS Biopsy

Standard of Care Treatment

Group Type: OTHER

TRUS Biopsy

Intervention Type: PROCEDURE

Standard of Care Treatment

TRUS/FUSION Biopsy

Interventional Treatment

Group Type: OTHER

TRUS/FUSION Biopsy

Intervention Type: PROCEDURE

Interventional Treatment

Interventions

TRUS Biopsy

Standard of Care Treatment

Intervention Type: PROCEDURE

TRUS/FUSION Biopsy

Interventional Treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

NHS Tayside

OTHER_GOV

Sponsor Role: collaborator

Prostate Cancer UK

OTHER

Sponsor Role: collaborator

Tayside Clinical Trials Unit

UNKNOWN

Sponsor Role: collaborator

Health Informatics Centre

UNKNOWN

Sponsor Role: collaborator

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Ghulam Nabi

Professor in Surgical Uro-oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghulam Nabi

Role: STUDY_DIRECTOR

University of Dundee

Locations

Ninewells Hospital and Medical School

Dundee, Tayside, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37489992 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31752954 (View on PubMed)

Other Identifiers

MULTIPROS Study

Identifier Type: -

Identifier Source: org_study_id