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

Value of Prostate Health Index for Prostate Cancer Diagnosis

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Measurement of Prostate Health Index (PHI)

• Study Type: Observational
• Enrollment (Actual): 472

Contacts and Locations

Study Locations

• France
  • Créteil, France
    • CHU Mondor
  • Le Kremlin-Bicêtre, France
    • CHU Kremlin-Bicêtre
  • Lille, France
    • Clinique Louvière de Lille
  • Lyon, France
    • Hopital Edouard Herriot
  • Montpellier, France
    • Clinique Beau Soleil
  • Paris, France
    • Hôpital Tenon
  • Pierre-Bénite, France, 69495
    • Unité Médicale d'Oncologie et de Transfert - Service de Biochimie et Biologie Moléculaire - Centre Hospitalier Lyon-Sud
  • Rennes, France
    • CHU de Rennes
  • Saint-Herblain, France
    • Clinique Atlantis
  • Toulouse, France
    • IUCT Oncopole de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	When the results of all prostate biopsies will be available (approximately at 7 months after the beginning of the study)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 69HCL17_0203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No