Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

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

Official title:

Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632930
• Other study ID #: 2011.660
• Status: Completed
• Phase: N/A
• Start date: July 2, 2012
• Est. completion date: April 26, 2021

Study information

• Verified date: February 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 962
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Months and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	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 Benite
France	Hôpital de la Milétrie	Poitiers
France	Centre hospitalier de Thonon les bains	Thonon Les Bains
France	Centre Hospitalier de Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point		24 months
Secondary	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	12 months
Secondary	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	12, 24 and 60 months
Secondary	Cost-efficiency study	To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion	24 months