Prostate Health Index for Prostate Cancer Diagnosis

Study Overview
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Brief Summary
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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.

Official Title
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Value of Prostate Health Index for Prostate Cancer Diagnosis

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Measurement of Prostate Health Index (PHI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients addressed for prostate biopsies because of clinical and/or biological suspicion of prostate cancer. | Device: Measurement of Prostate Health Index (PHI)<br>* Use of a diagnostic tool to predict prostate biopsy outcome: measurement of total and free PSA as well as the [-2]proPSA and calculation of The Prostate Health Index according to the following formula: Prostate Health Index (PHI) = [p2PSA /fPSA] x √tPSA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrinsic performances of Prostate Health Index in predicting prostate biopsy outcome | Area under receiver operating curve (ROC) analysis; the ROC curve will be constructed from the values of the sensitivity and specificity of Prostate Health Index by comparison to the gold standard, i.e. prostate biopsy outcome (cancer or not). | When the results of all prostate biopsies will be available (approximately at 7 months after the beginning of the study) |