Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

NCT ID: NCT01632930

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 962 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-02
• Study Completion Date: 2021-04-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Results of urinary PCA3 test will be available

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Results of urinary PCA3 test will not be available

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Months
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

France

Other Identifiers

2011.660

Identifier Type: -

Identifier Source: org_study_id