Prostate Health Index for Prostate Cancer Diagnosis

NCT03151356 | Completed

• 1 other identifier: 69HCL17_0203
• Study Type: observational
• Target: 472
• Locations: 1 country
• Sites: 10

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Patients

Patients addressed for prostate biopsies because of clinical and/or biological suspicion of prostate cancer.

Device: Measurement of Prostate Health Index (PHI)

Interventions

Measurement of Prostate Health Index (PHI) DEVICE

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (10)

CHU Mondor

Créteil, France

Location

CHU Kremlin-Bicêtre

Le Kremlin-Bicêtre, France

Location

Clinique Louvière de Lille

Lille, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Clinique Beau Soleil

Montpellier, France

Location

Hôpital Tenon

Paris, France

Location

Unité Médicale d'Oncologie et de Transfert - Service de Biochimie et Biologie Moléculaire - Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

CHU de Rennes

Rennes, France

Location

Clinique Atlantis

Saint-Herblain, France

Location

IUCT Oncopole de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 12, 2017
• Study Start: September 18, 2017
• Primary Completion: September 19, 2018
• Study Completion: October 19, 2018
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)