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ISRCTN
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ISRCTN04707454
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ClinicalTrials.gov identifier
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Public title
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Use of [-2]proPSA for the detection of prostate cancer in patients who are candidate for prostatic biopsy
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Scientific title
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Evaluation of the of the sensitivity, specificity and diagnostic accuracy of the [-2]proPSA biomarker and its derivatives for the detection of prostate cancer and determination of the relationship with prostate cancer characteristics at biopsy
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Acronym
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N/A
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Serial number at source
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2PROPSA
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Study hypothesis
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The two most commonly used tests for prostate cancer detection are digital rectal examination and serum prostate-specific antigen (PSA) level. In the last two decades, PSA has considerably improved our ability to detect prostate cancer (PCa). However, this marker has some limitations in sensitivity and specificity for prostate cancer detection leading to false negative and false positive results. Thus, in the recent years, several promising biomarkers have been studied in order to improve PSA specificity in the early detection of PCa. Preliminary reports have shown that some PSA precursors such as [-2]proPSA may be more specific than total PSA or free PSA in predicting the presence of PCa especially in the PSA range between 2 and 10 ng/mL. The goal of this trial is to test the ability of [-2]proPSA and its derivatives in discriminating between patients with or without PCa within a prospectively collected, multicentric, European, large and contemporary cohort of candidates for a prostate biopsy.
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Lay summary
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Lay summary under review
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Ethics approval
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Medical Ethics Committee, San Rafaele Hospital Milan, Italy, 8 April 2010, ref: 2PROPSA
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Study design
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Non-randomized observational multicenter trial
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Countries of recruitment
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France, Germany, Italy, Spain, United Kingdom
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Disease/condition/study domain
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Prostate cancer detection
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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]
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Anticipated start date
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01/05/2011
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Anticipated end date
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31/03/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1250
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Interventions
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For each patients included, as part of the standard care at each institution, blood will be drawn and serum (blood centrifuged and serum collected) will be prepared within 3 hours of the blood draw. The serum samples will be coded so that no patients name or details will be recorded. The serum samples will be then frozen at -20°C or -70°C. The samples will be then sent to Hospital San Rafaele in Milan for the determination of the PSA, fPSA and [-2]proPSA serum concentrations and calculation of the prostate health index (phi). The patients clinical information including diagnostic will be collected and coded at each institution and sent to the data manager at Hospital San Rafaele. The statistical analysis will be then performed at Hospital San Rafaele in Milan on the complete data set including laboratory information (PSA, fPSA, [-2]proPSA, phi) and clinical information. The performance of the new diagnostic test will be assessed in comparison with currently used test such as tPSA or %fPSA using ROC curve analysis, univariate and multivariante logistic regression and determination of gain in clinical specificity at a given sensitivity. Each patients included in the trail will be followed at each intitution for a period of 6 months following the initial blod draw.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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1. Determine a -2proPSA (and its derivatives) cut-off value to be used in clinical practice
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)
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Sources of funding
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Beckman Coulter Eurocenter S.A. (Switzerland)
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Trial website
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Publications
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Contact name
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Prof
Gorgio
Guazzoni
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Address
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Department of Urology
San Raffaele Turro Hospital
Via Stamira d'Ancona 20
20127 Milan Italy
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City/town
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Milan
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Zip/Postcode
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20127
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Country
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Italy
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Tel
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+39 (0)226 436 431
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Fax
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+39 (0)226 433 442
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Email
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sussman.amy@hsr.it
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Sponsor
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Beckman Coulter Eurocenter (Switzerland)
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Address
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22, rue Juste-Olivier
Case Postale 1044
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City/town
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Nyon
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Zip/Postcode
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CH-1260
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Country
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Switzerland
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Tel
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+33 (0)563 558 959
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Fax
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+33 (0)563 558 959
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Email
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jblanchet@beckmancoulter.com
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Sponsor website:
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http://www.beckmancoulter.com
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Date applied
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10/11/2011
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Last edited
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19/12/2011
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Date ISRCTN assigned
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19/12/2011
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