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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


N/A
18 Years
75 Years
Not Enrolling
Male
Prostate Cancer

Thank you

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

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