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Prostate Health Index for Prostate Cancer Diagnosis

NCT03151356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 472

Last updated 2019-08-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2018-09-19
Completion
2018-10-19

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03151356 on ClinicalTrials.gov