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Completed

NCT Number: NCT03615131

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Klinik für Urologie Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MRI-TRUS fusion prostate biopsy

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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

  3. lesion volume (ml)

    Time frame: 01.09.2015 - 30.03.2017

    millilitre; size of suspected areas in prostate gland in MRI

  4. 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)

  5. Prostate specific antigen (PSA)

    Time frame: 01.09.2015 - 30.03.2017

    ng per ml; enzyme secreted by the prostate gland

  6. Digital rectal examination (DRE)

    Time frame: 01.09.2015 - 30.03.2017

    consistence of prostate gland

  7. 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.

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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