Prostatic Neoplasms Clinical Trial
— PROSITOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | AOUP Ospedale cisanello | Pisa | Toscana |
Lead Sponsor | Collaborator |
---|---|
University of Pisa |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impedance-based analysis based on phase-sensitive sensors | during rectal examination |
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