Prostate Health Index for Prostate Cancer Diagnosis (PHI-1)
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|ClinicalTrials.gov Identifier: NCT03151356|
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : August 14, 2019
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: Measurement of Prostate Health Index (PHI)|
|Study Type :||Observational|
|Actual Enrollment :||472 participants|
|Official Title:||Value of Prostate Health Index for Prostate Cancer Diagnosis|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||September 19, 2018|
|Actual Study Completion Date :||October 19, 2018|
Patients addressed for prostate biopsies because of clinical and/or biological suspicion of prostate cancer.
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
- Intrinsic performances of Prostate Health Index in predicting prostate biopsy outcome [ Time Frame: When the results of all prostate biopsies will be available (approximately at 7 months after the beginning of the study) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151356
|Le Kremlin-Bicêtre, France|
|Clinique Louvière de Lille|
|Hôpital Edouard Herriot|
|Clinique Beau Soleil|
|Unité Médicale d'Oncologie et de Transfert - Service de Biochimie et Biologie Moléculaire - Centre Hospitalier Lyon-Sud|
|Pierre-Bénite, France, 69495|
|CHU de Rennes|
|IUCT Oncopole de Toulouse|