Plain English Summary
Background and study aims
The aim of this study is to investigate how well a new biomarker (a substance used as an indicator of the presence of prostate cancer) works to improve the detection of prostate cancer and reduce the number of negative prostate biopsies (where tissue is unnecessarily removed as it is not cancerous).
Who can participate?
Men from the participating institution scheduled for a prostate biopsy (removal of cancerous tissue), based on clinician decision.
What does the study involve?
One single blood sample was taken from those participating (which is already part of the standard care, for patients schedule for prostate biopsy). All patients will receive the appropriate treatment according to their condition and the study will have no influence of any kind on the choice of treatment offered to the patients.
What are the possible benefits and risks of participating?
Development of the new biomarker could improve detection of prostate cancer and reduce the number of negative prostate biopsies that are common with existing tests. This new biomarker can improve patient care by reducing the number of invasive and costly procedures. There are no known risks associated with this study.
Where is the study run from?
San Raffaele Hospital-Turro , Milan, Italy (Lead center).
Other centers: Hopital Henri Mondor, Paris, France; Fundacio Puigvert, Barcelona, Spain; University Hamburg-Eppendorf, Hamburg, Germany; Lister Hospital, Stevenage, UK
When is study starting and how long is it expected to run for?
Recruitment started in December 2011 and ended in March 2012. The study ran for 9 months.
Who is funding the study?
Beckman Coulter, Switzerland
Who is the main contact?
Ms Amy Sussman
sussman.amy@hsr.it
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gorgio Guazzoni
ORCID ID
Contact details
Department of Urology
San Raffaele Turro Hospital
Via Stamira d'Ancona 20
20127 Milan Italy
Milan
20127
Italy
+39 (0)226 436 431
sussman.amy@hsr.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2PROPSA
Study information
Scientific title
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
Acronym
Study hypothesis
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.
Ethics approval
Medical Ethics Committee, San Rafaele Hospital Milan, Italy, 08/04/2010, ref: 2PROPSA
Study design
Non-randomized observational multicenter trial
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prostate cancer
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
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)
Overall trial start date
01/05/2011
Overall trial end date
31/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
1250
Participant 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]
Recruitment start date
01/12/2011
Recruitment end date
31/03/2012
Locations
Countries of recruitment
France, Germany, Italy, Spain, United Kingdom
Trial participating centre
San Raffaele Turro Hospital
Milan
20127
Italy
Sponsor information
Organisation
Beckman Coulter Eurocenter (Switzerland)
Sponsor details
22
rue Juste-Olivier
Case Postale 1044
Nyon
CH-1260
Switzerland
+33 (0)563 558 959
jblanchet@beckmancoulter.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Beckman Coulter Eurocenter S.A. (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24361258