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

NCT03615131 | Completed

• 1 other identifier: 2016-01098
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; mpMRI-TRUS fusion biopsy; PIRADS; Gleason score

Outcome Measures

Primary Outcomes (7)

• Gleason score (minimum 2 to maximum of 10)

  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)

  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)

  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)

  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)

  ng per ml; enzyme secreted by the prostate gland

  01.09.2015 - 30.03.2017

• Digital rectal examination (DRE)

  consistence of prostate gland

  01.09.2015 - 30.03.2017

• Prostate specific antigen - density

  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

Study Arms (1)

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

Interventions

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.

Also known as: MRI prior to biopsy

MRI-TRUS fusion prostate biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Klinik für Urologie Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Prostate biopsies without DNA evaluation

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2015
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)