Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer

August 20, 2018 updated by: Kantonsspital Winterthur KSW

Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:

The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Materials and Methods: This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy).

Study Type

Observational

Enrollment (Actual)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zürich
      • Winterthur, Zürich, Switzerland, 8401
        • Klinik für Urologie Kantonsspital Winterthur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Men with a suspicious prostate cancer screening for the early detection of prostate cancer (PSA> 4 ng / ml, PSA velocity> 0.75 ng / ml / y or pathological DRE) or a planned re-biopsy in the context of active surveillance with known very-low-risk prostate cancer.

Description

Inclusion Criteria:

  • Patients with mRI-TRUS Fusion prostate biopsy
  • age > 18y
  • elevated PSA
  • suspicious DRE (digital rectal examination)
  • patients with prostate cancer under active surveillance

Exclusion Criteria:

  • age < 18y
  • treated prostate cancer (Radiotherapy, antiandrogens therapy, brachytherapy, HIFU).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MRI-TRUS fusion prostate biopsy
Single Arm Study, MRI and Prostate-Biopsy on same patient, individual patient acts as own control for intervention
Diagnostic test: MRI-TRUS fusion prostate biopsy
First an advanced MRI prostate image is obtained, annotated and recorded by the Radiology of the Kantonsspital Winterthur. Next, using special fusion technology, the recorded MRI image is fused with a live transrectal ultrasound by the Urologist who performs a MRI/TRUS fusion biopsy.
Other Names:
  • MRI prior to biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gleason score (minimum 2 to maximum of 10)
Time Frame: 01.09.2015 - 30.03.2017

Histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure.

Pattern 1 - corresponds to a well differentiated carcinoma. Pattern 2 - corresponds to a moderately differentiated carcinoma. Pattern 3 - invade the surrounding tissue or having an infiltrative pattern; corresponds to a moderately differentiated carcinoma.

Pattern 4 - corresponds to a poorly differentiated carcinoma. Pattern 5 - corresponds to an anaplastic carcinoma.

The pathologist then sums the pattern-number of the primary and secondary grades to obtain the final Gleason score.

Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.
01.09.2015 - 30.03.2017
ISUP (International Society of Urological Pathology) Grading Group (Grade 1 to Grade 5)
Time Frame: 01.09.2015 - 30.03.2017

New grading system for histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure

Grade Group 1 (Gleason score ≤6) - Only individual discrete well-formed glands Grade Group 2 (Gleason score 3+4=7) - Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands Grade Group 3 (Gleason score 4+3=7) - Predominantly poorly-formed/fused/cribriform glands with a lesser component of well-formed glands Grade Group 4 (Gleason score 8)

  • Only poorly-formed/fused/cribriform glands or
  • Predominantly well-formed glands with a lesser component lacking glands or
  • Predominantly lacking glands with a lesser component of well-formed glands Grade Group 5 (Gleason scores 9-10) - Lacks gland formation (or with necrosis) with or without poorly-formed/fused/cribriform glands
01.09.2015 - 30.03.2017
lesion volume (ml)
Time Frame: 01.09.2015 - 30.03.2017
millilitre; size of suspected areas in prostate gland in MRI
01.09.2015 - 30.03.2017
PI-RADS v2 (Prostate Imaging Reporting and Data System Version 2) score (1 - 5)
Time Frame: 01.09.2015 - 30.03.2017

Radiological grading system of prostate lesions in mpMRI

The PI-RADS v2 system is designed to standardize image acquisition and reporting, and to be used by medical professionals in the initial evaluation of patients to assess the risk of clinically significant prostate cancer that may require biopsy and treatment.

The scale is based on a score "Yes" or "No" for Dynamic Contrast-Enhanced (DCE) parameter, and from 1 to 5 for T2-weighted (T2W) and Diffusion-weighted imaging (DWI). The score is given for each lesion, with 1 being most probably benign and 5 being highly suspicious of malignancy:

PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2: low (clinically significant cancer is unlikely to be present) PI-RADS 3: intermediate (clinically significant cancer is equivocal) PI-RADS 4: high (clinically significant cancer is likely to be present) PI-RADS 5: very high (clinically significant cancer is highly likely to be present)
01.09.2015 - 30.03.2017
Prostate specific antigen (PSA)
Time Frame: 01.09.2015 - 30.03.2017
ng per ml; enzyme secreted by the prostate gland
01.09.2015 - 30.03.2017
Digital rectal examination (DRE)
Time Frame: 01.09.2015 - 30.03.2017
consistence of prostate gland
01.09.2015 - 30.03.2017
Prostate specific antigen - density
Time Frame: 01.09.2015 - 30.03.2017
ng per ml per ml; The relationship of the prostate specific antigen level to the size and weight (volume) of the prostate.
01.09.2015 - 30.03.2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Winterthur KSW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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