An observational study in Prostate Cancer, sponsored by Kantonsspital Winterthur KSW. Completed at 1 site in Switzerland. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by Kantonsspital Winterthur KSW · Observational
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.
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 157 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Kantonsspital Winterthur KSW is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
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.
Time frame: 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
Time frame: 01.09.2015 - 30.03.2017
lesion volume (ml)
millilitre; size of suspected areas in prostate gland in MRI
Time frame: 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)
Time frame: 01.09.2015 - 30.03.2017
Prostate specific antigen (PSA)
ng per ml; enzyme secreted by the prostate gland
Time frame: 01.09.2015 - 30.03.2017
Digital rectal examination (DRE)
consistence of prostate gland
Time frame: 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.
Time frame: 01.09.2015 - 30.03.2017
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kantonsspital Winterthur KSW