An observational study in Prostate Cancer, sponsored by Hospices Civils de Lyon. Completed at 10 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Hospices Civils de Lyon · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 472 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Patients addressed for prostate biopsies because of prostate cancer suspicion: serum total Prostate Specific Antigen ≥ 4 ng/mL and/or abnormal digital rectal examination and/or first degree familial history of prostate cancer.
Exclusion Criteria:
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
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).
Time frame: When the results of all prostate biopsies will be available (approximately at 7 months after the beginning of the study)
Plan to share: No
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon