ClinicalTrials.gov
ClinicalTrials.gov Menu

Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01632930
Recruitment Status : Active, not recruiting
First Posted : July 3, 2012
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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 or disease Intervention/treatment Phase
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) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 962 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
Actual Study Start Date : July 2, 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Medical impact of availability of PCA3 test results [ Time Frame: 12 months ]
    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

  2. Diagnostic performances of urinary PCA3 test [ Time Frame: 12, 24 and 60 months ]
    Intrinsic performances of PCA3 test in predicting prostate biopsy results in term of sensitivity, specificity and area under ROC curves

  3. Cost-efficiency study [ Time Frame: 24 months ]
    To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632930


Locations
France
CHU Angers
Angers, France, 49933
Hôpital privé des Pays de Savoie
Annemasse, France
Hôpital de la Cavale blanche
Brest, France, 29609
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, France
Hôpital du Bocage
Dijon, France, 21079
Hôpital Edouard Herriot
Lyon, France
Hôpital Pitié-Salpêtrière,
Paris, France, 75013
Hôpital Tenon
Paris, France, 75020
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Hôpital de la Milétrie
Poitiers, France, 86000
Centre hospitalier de Thonon les bains
Thonon Les Bains, France
Centre Hospitalier de Valence
Valence, France
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01632930     History of Changes
Other Study ID Numbers: 2011.660
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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