Prostate Health Index for Prostate Cancer Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-18

Study Completion Date

2018-10-19

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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients addressed for prostate biopsies because of clinical and/or biological suspicion of prostate cancer.

Measurement of Prostate Health Index (PHI)

Intervention Type DEVICE

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

Interventions

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Measurement of Prostate Health Index (PHI)

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No