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NCT Number: NCT01632930

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.

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Key information

Conditions

Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 month and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)

Other

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 outcomes

  1. Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2012
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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