Prostate Impendance Test Project

• Conditions: Prostatic Neoplasms; PSA; Prostatic Biopsy; Impedance Test

• Registration Number: NCT03428087
• Lead Sponsor: University of Pisa

Brief Summary

Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2018-02
• Primary Completion: 2018-02-02
• Study First Submitted: 2018-02-03
• Study First Submitted QC: 2018-02-03
• Study First Posted: 2018-02-09
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. age> 45 years
2. up of total PSA values beyond the normal range (> 4 ng / ml)
3. presence or absence of suspicious prostate nodule

Exclusion Criteria

1. previous history of cancer
2. BMI>30
3. patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impedance-based analysis based on phase-sensitive sensors	during rectal examination

Trial Locations

Locations (1)

AOUP Ospedale cisanello; 🇮🇹 Pisa, Toscana, Italy