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

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: MRI-TRUS fusion prostate biopsy

• Registration Number: NCT03615131
• Lead Sponsor: Kantonsspital Winterthur KSW

Brief Summary

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-30
• Status Verified: 2018-08
• Study First Posted: 2018-08-03
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 157

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI-TRUS fusion prostate biopsy	MRI-TRUS fusion prostate biopsy	Single Arm Study, MRI and Prostate-Biopsy on same patient, individual patient acts as own control for intervention

Primary Outcome Measures

Name	Time	Method
Gleason score (minimum 2 to maximum of 10)	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.
ISUP (International Society of Urological Pathology) Grading Group (Grade 1 to Grade 5)	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
lesion volume (ml)	01.09.2015 - 30.03.2017	millilitre; size of suspected areas in prostate gland in MRI
PI-RADS v2 (Prostate Imaging Reporting and Data System Version 2) score (1 - 5)	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)
Prostate specific antigen (PSA)	01.09.2015 - 30.03.2017	ng per ml; enzyme secreted by the prostate gland
Digital rectal examination (DRE)	01.09.2015 - 30.03.2017	consistence of prostate gland
Prostate specific antigen - density	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.

Trial Locations

Locations (1)

Klinik für Urologie Kantonsspital Winterthur; 🇨🇭 Winterthur, Zürich, Switzerland