Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

Not Applicable

Completed

• 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)

• Registration Number: NCT01632930
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-06-29
• Study Start: 2012-07-02
• Study First Posted: 2012-07-03
• Primary Completion: 2021-04-26
• Study Completion: 2021-04-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 962

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Results of urinary PCA3 test will be available	urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)	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
Results of urinary PCA3 test will not be available	urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)	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

Primary Outcome Measures

Name	Time	Method
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point	24 months

Secondary Outcome Measures

Name	Time	Method
Cost-efficiency study	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	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	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

Trial Locations

Locations (10)

Centre Hospitalier Alpes Leman; 🇫🇷 Contamine-sur-Arve, France

CHU Angers; 🇫🇷 Angers, France

Hôpital du Bocage; 🇫🇷 Dijon, France

Hôpital Pitié-Salpêtrière,; 🇫🇷 Paris, France

Hôpital Tenon; 🇫🇷 Paris, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Hôpital de la Milétrie; 🇫🇷 Poitiers, France

Centre hospitalier de Thonon les bains; 🇫🇷 Thonon Les Bains, France

Centre Hospitalier de Valence; 🇫🇷 Valence, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France