Biparametric MRI for Detection of Significant Prostate Cancer

NCT02584179 | Completed DMC

• 1 other identifier: Herlev-MR-Prost-BP
• Study Type: interventional
• Target: 1,063
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to develop a new diagnostic approach to improve the diagnosis of men suspicious of having significant prostate cancer (sPCa). The current diagnostic technique (standard transrectal ultrasound-guided biopsies \[TRUS-bx\]) rely on multiple prostate biopsy cores (10-12 samples) and if negative repeated biopsy sessions. This increases both patient complications (severe infections, bleeding and anxiety) and the diagnosis of insignificant cancer causing overtreatment. Still, significant cancers are missed. In addition, worldwide antibiotic-resistant bacteria increase, while effective antibiotics are declining. Thus, a noninvasive diagnostic tool to improve selection of men with clinically suspicion of PCa who need a biopsy from those who can avoid one is strongly needed. Previous studies in our department show that MRI in a selected patient cohort with prior negative TRUS-bx can improve the detection rate of clinically significant PCa and allows for a more accurate assessment of cancer stage and aggressiveness. However, the value of an MRI used as a first-line tool in the diagnostic examination of men in suspicion of PCa is uncertain. Furthermore, a full scale MRI prostate examination recommended by the European Society of Urogenital Radiology includes intravenous contrast-media and multiple sequences. This is both time-consuming and cost full, which reduces its feasibility for more widespread clinical implementation. We believe that a simpler, faster biparametric MRI (bpMRI) using less scan sequences and circumvents intravenous contrast-media and anti-peristaltic drugs would decrease image acquisition time, reduce costs and is sufficient to preserve diagnostic accuracy for sPCa detection in biopsy-naive men. Consequently, we will include biopsy-naive men in a protocol-based research project. The objective is to assess the diagnostic accuracy of bpMRI to rule out sPCa and whether a bpMRI can be used as a diagnostic non-invasive screening tool to 1) improve the diagnosis of sPCa 2) assess cancer aggressiveness 3) increase precision of biopsies and 4) reduce the number of biopsy sessions and cores. We evaluate the clinical significance of the detected cancers and whether bpMRI could be used as a triage test to improve the diagnosis of sPCa and aid in the determination of which men could safely avoid unnecessary biopsies. This new diagnostic approach has the potential to significantly reduce patient hazards and complications. We aim to reach 1000 included men. We believe that bpMRI used in the clinical decision-making has the potential to change the future management of PCa. However, we still miss the scientific evidence to substantiate its preliminary promising results before this technique can be widely used to benefit all men. This large research project is to the best of our knowledge powered to include the largest patient sample size published within this field.

Conditions

Prostate Cancer

Keywords

mpMRI, significant cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of a bp-MRI in detection and ruling out significant PCa in biopsy-naive men

  All included men undergo bp-MRI at inclusion followed by diagnostic standard TRUS biopsies (current diagnostic standard). Men with any suspicious lesions on bpMRI undergo additional bpMRI-guided biopsies (bpMRI-bx) using bpMRI-TRUS image fusion based software. BpMRI suspicion scores and biopsy results ( detection of any PCa and sPCa) from standard TRUS-bx and bpMRI-bx are compared using combined biopsy results as standard reference. Sensitivity and negative predictive value of bpMRI to detect and rule out sPCa will be determined

  24 months

Study Arms (1)

Biparametric MRI before biopsy

EXPERIMENTAL

Biparametric MRI is a reduced Multiparametric MRI using less scan sequences and no intravenous contrast. All men will have standard transrectal ultrasound guided biopsies

Device: Biparametric MRI before biopsy

Interventions

Biparametric MRI before biopsy DEVICE

All included men with suspicious lesions on bpMRI will have bpMRI targeted biopsies in addition to standard TRUS-bx.

Also known as: BpMRI

Biparametric MRI before biopsy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 85 years.
• Clinical suspicion of PCa based on: serum level of prostate-specific-antigen (PSA) from 2.5 ng/ml in two consecutive measurements and/or abnormal diagital rectal examination (DRE).
• Mental status: Patients must be able to understand the objective of the study.
• Informed consent: The patient must sign the local Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.

You may not qualify if:

• Previous prostate biopsies.
• Previous diagnosis of PCa.
• Acute prostatitis.
• Contraindications to MRI (cardiac pacemaker, claustrophobia etc).
• Infection (temperature \> 38 degrees Celsius)
• Hip replacement surgery or other metal implants in the pelvic area.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Henrik Thomsen, MD

  Herlev Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark

  STUDY CHAIR

• Lars Boesen, MD, PhD

  Deptartment of Urology, Herlev Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand. med.

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: October 22, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)