Biparametric MRI for Detection of Significant Prostate Cancer

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

Interventions

DEVICE

Biparametric MRI before biopsy

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

Sponsors & Collaborators

• Herlev Hospital

  lead OTHER

Principal Investigators

• Henrik Thomsen, MD · Herlev Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark

• Lars Boesen, MD, PhD · Deptartment of Urology, Herlev Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2017-06-30

Completion

2018-12-01

Countries

• Denmark

Study Locations