Clinical trial NCT03615131: Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer
Official title: Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
mpMRI-TRUS fusion biopsy
PIRADS
Gleason score
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 157
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Gleason score (minimum 2 to maximum of 10)
timeFrame: 01.09.2015 - 30.03.2017
measure: ISUP (International Society of Urological Pathology) Grading Group (Grade 1 to Grade 5)
timeFrame: 01.09.2015 - 30.03.2017
measure: lesion volume (ml)
timeFrame: 01.09.2015 - 30.03.2017
measure: PI-RADS v2 (Prostate Imaging Reporting and Data System Version 2) score (1 - 5)
timeFrame: 01.09.2015 - 30.03.2017
measure: Prostate specific antigen (PSA)
timeFrame: 01.09.2015 - 30.03.2017
measure: Digital rectal examination (DRE)
timeFrame: 01.09.2015 - 30.03.2017
measure: Prostate specific antigen - density
timeFrame: 01.09.2015 - 30.03.2017
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Klinik für Urologie Kantonsspital Winterthur
state: Zürich
Study officials:
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