Predictive Value of Prostate-specific Antigen Isoform p2psa and Its Derivates in the Diagnosis of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672411
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : February 26, 2013
Information provided by (Responsible Party):
Luigi Mearini, University Of Perugia

Brief Summary:

In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of 214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have been developed in order to identify PCa while it is still confined to the prostate gland.

The two most commonly used tests are digital rectal examination and serum prostate-specific antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels may change as result of physical activity, sexual activity, in the presence of benign prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of PCa.

A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering prostate biopsy and large programs for the early detection of prostate cancer have shown that almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml; moreover, the levels of free and bound PSA have been assessed, together with PSA density (the rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem to have some validity for detecting prostate cancer.

Recent studies have shown that other new biomarkers could be used in the diagnosis of early prostate cancer as they showed a higher sensitivity and specificity. In the last two years, several investigators showed that PSA isoform [−2] proPSA (p2PSA) and its derivatives, namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA / free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa aggressiveness at biopsy.

The aim of this study is to confirm the diagnostic and prognostic predictive value of prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.

Condition or disease
Prostate Cancer

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. diagnosis of prostate cancer [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures :
  1. prognosis of prostate cancer [ Time Frame: 6 months ]
    Analyzing the predictive value of %p2PSA and PHI in comparison with standard test (tPSA, fPSA, %fPSA, PSA density, DRE) in the evaluation of aggressiveness of prostate cancer, based on Gleason score groups at biopsy (low risk 4-6, Intermediate risk =7, high risk >=8).

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Urological outpatient clinics of one tertiary university high volume department of urology

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01672411

University of Perugia - Urology Dept
Perugia, Italy, 06100
Sponsors and Collaborators
University Of Perugia

Responsible Party: Luigi Mearini, Dr, University Of Perugia Identifier: NCT01672411     History of Changes
Other Study ID Numbers: propsa12
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Luigi Mearini, University Of Perugia:
prostate cancer, PSA, markers, diagnosis, prognosis, pro-PSA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases