Prostate Impendance Test Project (PROSIT)

Prostate Impendance Test Project (PROS.IT) in Prostate Cancer Diagnosis: a Cross-sectional Observational Study

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Tommaso Di Vico, Resident; Phone Number: 3393642655; Email: urologiapisa@gmail.com

Study Locations

• Italy
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • Recruiting
      • AOUP Ospedale cisanello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Impedance-based analysis based on phase-sensitive sensors	during rectal examination

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): February 2, 2018
• Study Completion (ANTICIPATED): June 30, 2018

Study Registration Dates

• First Submitted: February 3, 2018
• First Submitted That Met QC Criteria: February 3, 2018
• First Posted (ACTUAL): February 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 151/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No