Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients (PROCEDE-2000)

Myriad Genetic Laboratories

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02209584

PROCEDE-2000

Details and patient eligibility

About

This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions when added to standard clinical-pathological parameters in men with newly diagnosed prostate cancer.

Enrollment: 274 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
• Clinically localized (no evidence on clinical or imaging studies of advanced disease.
• No hormonal therapy including LHRH agonist or antagonist, anti-androgen, 5-alpha reductase inhibitor, estrogens or exogenous androgens, when applicable.
• Sufficient amount of tissue remains from biopsy to perform genomic testing.

Exclusion criteria

• Patients with known history of hypogonadism will be excluded from the registry