Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01632930
First received: June 29, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. Overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. In this population, there is no consensus recommendation on how to care, leading to repeated invasive biopsies, potential sources of complications.

The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the positivity of prostate biopsies, especially in patients who had at least one negative biopsy. Proposed in clinical practice in France as a commercial kit, it is expensive and is not covered by health insurance. It is therefore essential to assess the medical and economic impact of its introduction into medical practice.

The investigators propose to set up a study of high standard of proof, multicenter, based on recruitment of patients treated in hospitals. This working hypothesis is that the availability of the PCA3 test results would reduce the number of invasive biopsies performed incorrectly in patients already had at least one negative biopsy, thus improving the diagnostic strategy of prostate cancer.


Condition Intervention
Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination
Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical impact of availability of PCA3 test results [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine whether availability of PCA3 test results influences patient management in terms of physical examinations, , PSA testing, prostate ultrasonography, prostate MRI and delay in performing these tests

  • Diagnostic performances of urinary PCA3 test [ Time Frame: 12, 24 and 60 months ] [ Designated as safety issue: No ]
    Intrinsic performances of PCA3 test in predicting prostate biopsy results in term of sensitivity, specificity and area under ROC curves

  • Cost-efficiency study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion


Estimated Enrollment: 900
Study Start Date: July 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Results of urinary PCA3 test will be available
In this arm, physicians will have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion is likely to be influenced by urinary PCA3 test results
Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
urinary PCA3 test will be performed in patients before they undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination. Patients with negative biopsies will be definitively enrolled in the study. The physician in charge will have knowledge of PCA3 test results and will be asked to determine the subsequent follow-up taking these results into account.
Active Comparator: Results of urinary PCA3 test will not be available
In this arm, physicians will not have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion will therefore not be influenced by urinary PCA3 test results
Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
urinary PCA3 test will be performed in patients before they undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination. Patients with negative biopsies will be definitively enrolled in the study. The physician in charge will have knowledge of PCA3 test results and will be asked to determine the subsequent follow-up taking these results into account.

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients ≥ 18 year-old
  • patients who undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination
  • patients who gave informed consent

Exclusion Criteria:

  • no informed consent
  • medical history of or current significant prostate cancer
  • medical history of or current extra-prostatic cancer
  • high risk of loss of follow-up
  • clinically obvious prostate cancer (clinical stage ≥ T3, PSA ≥ 50 ng/ml, lymph node involvement, osteolytic bone metastases)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632930

Contacts
Contact: Virginie VLAEMINCK-GUILLEM, MD, PhD 4 78 86 29 92 ext +33 virginie.vlaeminck-guillem@chu-lyon.fr
Contact: Valérie Plattner 4 72 11 52 13 ext +33

Locations
France
CHU Angers Recruiting
Angers, France, 49933
Contact: Rahmene AZZOUZI, Dr    2 41 35 35 18 ext +33    arazzouzi@chu-angers.fr   
Principal Investigator: Rahmene AZZOUZI, Dr         
Hôpital privé des Pays de Savoie Not yet recruiting
Annemasse, France
Contact: Mikael HOCH, PH    450822760 ext +33    mhoch@ch-alpes-leman.fr   
Principal Investigator: Mikael HOCH, PH         
Hôpital de la Cavale blanche Recruiting
Brest, France, 29609
Contact: Antoine VALERI, Pr    2 98 34 71 69 ext +33    Antoine.Valeri@univ-brest.fr   
Principal Investigator: Antoine VALERI, Pr         
Centre Hospitalier Alpes Leman Not yet recruiting
Contamine-sur-Arve, France
Contact: Emilie ADAM, PH       emi.ad@hotmail.fr   
Principal Investigator: Emilie ADAM, PH         
Hôpital du Bocage Recruiting
Dijon, France, 21079
Contact: Luc CORMIER, Pr    3 80 29 35 80 ext +33    luc.cormier@chu-dijon.fr   
Principal Investigator: Luc CORMIER, Pr         
Hôpital Edouard Herriot Recruiting
Lyon, France
Contact: Marc Marc COLOMBEL, Pr    4 72 11 91 91 ext +33    marc.colombel@chu-lyon.fr   
Principal Investigator: Marc COLOMBEL, Pr         
Hôpital Pitié-Salpêtrière, Recruiting
Paris, France, 75013
Contact: Marc Olivier BITKER, Pr    1 42 17 71 11 ext +33    mo.bitker@psl.aphp.fr   
Principal Investigator: Marc Olivier BITKER, Pr         
Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Olivier CUSSENOT, Pr    1 56 01 64 95 ext +33    olivier.cussenot@tnn.aphp.fr   
Principal Investigator: Olivier CUSSENOT, Pr         
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: Alain RUFFION, Pr    4 72 67 88 09 ext +33    alain.ruffion@chu-lyon.fr   
Principal Investigator: Alain RUFFION, Pr         
Hôpital de la Milétrie Recruiting
Poitiers, France, 86000
Contact: Jacques IRANI, Pr    5 49 44 44 77 ext +33    j.irani@chu-poitiers.fr   
Principal Investigator: Jacques IRANI, Pr         
Centre hospitalier de Thonon les bains Not yet recruiting
Thonon Les Bains, France
Contact: Jean-luc LANDRY, PH       j-landry@ch-hopitauxduleman.fr   
Principal Investigator: Jean-Luc LANDRY, PH         
Centre Hospitalier de Valence Recruiting
Valence, France
Contact: Maximilien GORIS GBENOU, PH    475757576 ext +33    mgoris@ch-valence.fr   
Principal Investigator: Maximilien GORISGBENOU, PH         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01632930     History of Changes
Other Study ID Numbers: 2011.660
Study First Received: June 29, 2012
Last Updated: April 30, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Hospices Civils de Lyon:
diagnosis
prostate cancer
urine
medical economics

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

ClinicalTrials.gov processed this record on July 26, 2014