Clinical trial NCT01632930: Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
Official title: Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination
Keywords: diagnosis
prostate cancer
urine
medical economics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 962
Sex: MALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
timeFrame: 24 months
Secondary outcomes:
measure: Medical impact of availability of PCA3 test results
timeFrame: 12 months
measure: Diagnostic performances of urinary PCA3 test
timeFrame: 12, 24 and 60 months
measure: Cost-efficiency study
timeFrame: 24 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Contamine-sur-Arve
country: France
facility: Centre Hospitalier Alpes Leman
city: Dijon
country: France
facility: Hôpital du Bocage
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière,
city: Paris
country: France
facility: Hôpital Tenon
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Hôpital de la Milétrie
city: Thonon Les Bains
country: France
facility: Centre hospitalier de Thonon les bains
city: Valence
country: France
facility: Centre Hospitalier de Valence
Study officials:
References: