An observational study in Prostatic Neoplasms, PSA and Prostatic Biopsy, sponsored by University of Pisa. Status unknown at 1 site in Italy. Open to male participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by University of Pisa · Observational
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.
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.
Exclusion Criteria:
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.
Impedance-based analysis based on phase-sensitive sensors
Time frame: during rectal examination
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University of Pisa