Prostate Health Index for Prostate Cancer Diagnosis

Prostate Cancer Clinical Trial

— PHI-1  

Official title:

Value of Prostate Health Index for Prostate Cancer Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151356
• Other study ID #: 69HCL17_0203
• Status: Completed
• Start date: September 18, 2017
• Est. completion date: October 19, 2018

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: October 19, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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 vtPSA

Locations

Country	Name	City	State
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	CHU de Rennes	Rennes
France	Clinique Atlantis	Saint-Herblain
France	IUCT Oncopole de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)