Trial Information
Predictive Value of Prostate-specific Antigen Isoform p2psa and Its Derivates, %p2psa and Prostate Health Index in the Detection of Prostate Cancer and in Predicting Aggressive Disease: a Prospective Study
Inclusion Criteria:
- Men aged 18-75
- Total serum PSA of 2.0-10 ng/ml at entry and/or suspicious digital rectal examination
- Patients suitable for prostate biopsy
Exclusion Criteria:
- History of PCa
- Previous prostate biopsy or prostatic surgery
- History of acute urinary retention within 3 months prior
- Use of any investigational or marketed 5ARI, anabolic steroids or any drug with
anti-androgenic properties within 12 months prior to screening.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
diagnosis of prostate cancer
Outcome Description:
Analyzing the predictive value of %p2PSA and PHI in comparison with standard test (tPSA, fPSA, %fPSA, PSA density, DRE) in the diagnosis of prostate cancer.
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
Italy: University of Perugia
Study ID:
propsa12
NCT ID:
NCT01672411
Start Date:
April 2012
Completion Date:
December 2012
Related Keywords:
- Prostate Cancer
- prostate cancer, PSA, markers, diagnosis, prognosis, pro-PSA
- Prostatic Neoplasms