Prostate Impendance Test Project

Prostatic Neoplasms Clinical Trial

— PROSIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03428087
• Other study ID #: 151/2016
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2018
• Last updated: February 15, 2018
• Start date: July 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2018
• Source: University of Pisa
• Contact: Tommaso Di Vico, Resident
• Phone: 3393642655
• Email: urologiapisa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Impedance Test
• Prostatic Biopsy
• Prostatic Neoplasms
• PSA

Locations

Country	Name	City	State
Italy	AOUP Ospedale cisanello	Pisa	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impedance-based analysis based on phase-sensitive sensors		during rectal examination