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

Kantonsspital Winterthur KSW

Status: Completed

Conditions: Prostate Cancer

Treatments: Diagnostic Test: MRI-TRUS fusion prostate biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03615131

2016-01098

Details and patient eligibility

About

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.

Full 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).

Enrollment: 157 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

157 participants in 1 patient group

MRI-TRUS fusion prostate biopsy

Description:

Single Arm Study, MRI and Prostate-Biopsy on same patient, individual patient acts as own control for intervention

Treatment:

Diagnostic Test: MRI-TRUS fusion prostate biopsy