Clinical trial NCT03151356: Prostate Health Index for Prostate Cancer Diagnosis
Official title: Value of Prostate Health Index for Prostate Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 472
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Intrinsic performances of Prostate Health Index in predicting prostate biopsy outcome
timeFrame: When the results of all prostate biopsies will be available (approximately at 7 months after the beginning of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHU Mondor
city: Le Kremlin-Bicêtre
country: France
facility: CHU Kremlin-Bicêtre
city: Lille
country: France
facility: Clinique Louvière de Lille
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Paris
country: France
facility: Hôpital Tenon
city: Pierre-Bénite
country: France
facility: Unité Médicale d'Oncologie et de Transfert - Service de Biochimie et Biologie Moléculaire - Centre Hospitalier Lyon-Sud
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Herblain
country: France
facility: Clinique Atlantis
city: Toulouse
country: France
facility: IUCT Oncopole de Toulouse
Study officials:
References: