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Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

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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

June 29, 2012
July 3, 2012
August 22, 2017
July 2, 2012
June 2020   (Final data collection date for primary outcome measure)
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point [ Time Frame: 24 months ]
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01632930 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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
  • 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
  • Cost-efficiency study [ Time Frame: 12 months ]
    To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion
Not Provided
Not Provided
 
Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
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.
  • 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
    Intervention: Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
  • 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
    Intervention: Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
962
650
November 2020
June 2020   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
18 Months and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01632930
2011.660
No
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP