Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

Civil Hospices of Lyon

Status: Completed

Conditions: Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01632930

2011.660

Details and patient eligibility

About

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.

Enrollment: 962 patients

Sex: Male

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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962 participants in 2 patient groups

Results of urinary PCA3 test will be available

Experimental group

Description:

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

Treatment:

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

Results of urinary PCA3 test will not be available

Active Comparator group

Description:

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

Treatment:

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