Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
N/A
18 Months
N/A
18 Months
N/A
Not Enrolling
Male
Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination
Male
Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination
Trial Information
Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
Outcome Time Frame:
12 months
Safety Issue:
No
Authority:
France: The Commission nationale de l’informatique et des libertés
Study ID:
2011.660
NCT ID:
NCT01632930
Start Date:
June 2012
Completion Date:
December 2019
Related Keywords:
- Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination
- diagnosis
- prostate cancer
- urine
- medical economics
- Prostatic Neoplasms
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