se of [-2]proPSA for the detection of prostate cancer in patients who are candidate for prostatic biopsy

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN04707454
• Lead Sponsor: Beckman Coulter Eurocenter (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-19
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1250

Inclusion Criteria

1. Male patients older than 45 years old
2. Negative/positive digital rectal examination
3. Patients subjected to previous prostate biopsy will be included and analyzed in a nested case control study
4. Patients treated with drugs that may alter serum PSA levels (Finasteride and Dutasteride) will be included and analysed later in a nested case control study

Exclusion Criteria

1. Patients with bacterial acute prostatitis and with a positive sperm culture in the last three months prior to biopsy
2. Patients subjected to previous endoscopic surgery of the prostate (TransUrethral Resection of the Prostate [TURP] or Holmium-laser Enucleomorcellation of the Prostate [HoLEP]

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the specificity, sensitivity and diagnostic accuracy of -2proPSA and its derivatives (index text) in determining the presence of PCa at prostate biopsy and to compare them with those of total and free PSA (referenced text). Thus, we will quantify the number of prostate biopsies that can be spared using -2proPSA in the prostate biopsy decision path.

Secondary Outcome Measures

Name	Time	Method
1. Determine a -2proPSA (and its derivatives) cut-off value to be used in clinical practice<br>2. Determine the relationship between -2proPSA (and its derivatives) and PCa characteristics at biopsy (e.g. Gleason grade, % of cores involved, % of involvement of a single core)