Condition category
Cancer
Date applied
10/11/2011
Date assigned
19/12/2011
Last edited
03/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.beckmancoulter.com

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24361258

Publication citations

Additional files

Editorial Notes