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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615131
• Other study ID #: 2016-01098
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: March 30, 2017

Study information

• Verified date: August 2018
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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.

Locations

Country	Name	City	State
Switzerland	Klinik für Urologie Kantonsspital Winterthur	Winterthur	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	lesion volume (ml)	millilitre; size of suspected areas in prostate gland in MRI	01.09.2015 - 30.03.2017
Primary	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
Primary	Prostate specific antigen (PSA)	ng per ml; enzyme secreted by the prostate gland	01.09.2015 - 30.03.2017
Primary	Digital rectal examination (DRE)	consistence of prostate gland	01.09.2015 - 30.03.2017
Primary	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