Prostate Health Index for Prostate Cancer Diagnosis
Prostate Health Index for Prostate Cancer Diagnosis
Prostate biopsies are the gold standard for prostate cancer (PCa) diagnosis. They are
 performed according to the results of the measurement of prostate-specific antigen (PSA) in
 the serum of patients with PCa suspicion. More than half of the prostate biopsies reveal
 eventually negative because of the poor specificity of prostate-specific antigen assay. The
 Prostate Health Index (PHI) is a new diagnostic tool that has been described as a good
 predictor of prostate biopsy outcome. No large study has been performed so far in France.
 This study aim to evaluate Prostate Health Index diagnostic performances in a large
 multicentric French cohort of patients undergoing prostate biopsies because of clinical
 and/or biological suspicion of prostate cancer.

 Prostate Health Index will be measured in patients directed to prostate biopsies according to
 usual practices. Inclusion of 400 patients within 6 months in 12 French centers is expected.
 The ability of Prostate Health Index to predict prostate cancer at biopsy will be evaluated
 in terms of intrinsic and extrinsic diagnostic performances including sensitivity,
 specificity, predictive values, diagnostic accuracy, area under receiver operating curves and
 decision curve analyses.
Inclusion Criteria:

 -  Man ≥ 18 years old

 -  Addressed for prostate biopsy because of serum total Prostate Specific Antigen ≥ 4
 ng/mL and/or abnormal digital rectal examination and/or first degree familial history
 of prostate cancer

 -  Agreeing to participate to the study

 Exclusion Criteria:

 -  Personal history of positive prostate biopsy (evidence of prostate cancer)

 -  Personal history or evidence of prostate cancer based on clinical data (highly
 suspicious digital rectal examination (≥cT3) and/or serum total PSA ≥ 20 ng/mL and/or
 evidence for lymph node or bone metastases (retroperitoneal lymph nodes, bone lesions
 …)

 -  Evidence for synchronous non-prostate cancer (current active treatment)

 -  Adult protected by law