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Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

NCT01632930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 962

Last updated 2022-02-03

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-02
Primary Completion
2021-04-26
Completion
2021-04-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632930 on ClinicalTrials.gov