Prostate Impendance Test Project

NCT03428087 | Unknown

• 1 other identifier: 151/2016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; PSA; Prostatic Biopsy; Impedance Test

Outcome Measures

Primary Outcomes (1)

• Impedance-based analysis based on phase-sensitive sensors

  during rectal examination

Study Arms (1)

patients undergoing prostatic biopsy

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In order to build a two-pronged analysis of areas of confidence and tolerance, it is necessary to examine a fair number of potentially ill subjects and compare them with healthy subjects (controls). Past experiences indicate that about 100 measurements in each grop can create a sufficiently dense and significant cluster to be able to trace besides the "boundries" of 50%, 75%, and 95% even a 95% confidence center of small size suitable to establish an adequate significance.

You may qualify if:

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

You may not qualify if:

• previous history of cancer
• BMI\>30
• patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

AOUP Ospedale cisanello

Pisa, Tuscany, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Tommaso Di Vico, Resident

CONTACT

3393642655; urologiapisa@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prostate Impedance Test (PROS.iT) Project in prostate cancer diagnosis: a cross-sectional observational study

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: February 9, 2018
• Study Start: July 1, 2017
• Primary Completion: February 2, 2018
• Study Completion: June 30, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

IT (1)