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

Civil Hospices of Lyon

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Measurement of Prostate Health Index (PHI)

Study type: Observational

Funder types: Other

Identifiers

NCT03151356

69HCL17_0203

Details and patient eligibility

About

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.

Enrollment: 472 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

472 participants in 1 patient group

Patients

Description:

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

Treatment:

Device: Measurement of Prostate Health Index (PHI)