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Prostate Health Index for Prostate Cancer Diagnosis (PHI-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151356
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment
Prostate Cancer Device: Measurement of Prostate Health Index (PHI)

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Study Type : Observational
Actual Enrollment : 472 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients
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




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
CHU Mondor
Créteil, France
CHU Kremlin-Bicêtre
Le Kremlin-Bicêtre, France
Clinique Louvière de Lille
Lille, France
Hôpital Edouard Herriot
Lyon, France
Clinique Beau Soleil
Montpellier, France
Hôpital Tenon
Paris, France
Unité Médicale d'Oncologie et de Transfert - Service de Biochimie et Biologie Moléculaire - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
CHU de Rennes
Rennes, France
Clinique Atlantis
Saint-Herblain, France
IUCT Oncopole de Toulouse
Toulouse, France
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03151356    
Other Study ID Numbers: 69HCL17_0203
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases