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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
962
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.
CHU Angers
Angers, France
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, France
Hôpital du Bocage
Dijon, France
Hôpital Edouard Herriot
Lyon, France
Hôpital Pitié-Salpêtrière,
Paris, France
Hôpital Tenon
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Hôpital de la Milétrie
Poitiers, France
Centre hospitalier de Thonon les bains
Thonon-les-Bains, France
Centre Hospitalier de Valence
Valence, France
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
Time frame: 24 months
Medical impact of availability of PCA3 test results
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
Time frame: 12 months
Diagnostic performances of urinary PCA3 test
Intrinsic performances of PCA3 test in predicting prostate biopsy results in term of sensitivity, specificity and area under ROC curves
Time frame: 12, 24 and 60 months
Cost-efficiency study
To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion
Time frame: 24 months
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