Prostate Impendance Test Project (PROSIT)

University of Pisa

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03428087

151/2016

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

patients undergoing prostatic biopsy

Description:

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.