Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing

This is a multicenter, retrospective, observational study in men diagnosed with localized PrCa who had Prolaris testing prior to the treatment decision. The study will collect demographic, clinical, pathologic, and Prolaris test data from medical records and Myriad's Prolaris database.

The primary objective of this study is to evaluate the rate of BCR or metastasis, whichever occurs first, among Prolaris-tested men who were at low risk of DSM (≤3.2%), who also met NCCN low-risk criteria, and who were initially treated with AS.

The secondary objectives of the study are to evaluate the frequency of AS selection among all men who had low DSM risk, as determined by Prolaris testing and AS durability among Prolaris-tested men with low DSM risk who selected and initiated this treatment.

Inclusion criteria

• Diagnosed with localized PrCa at participating sites between January 1, 2013 and August 1, 2017.
• Have undergone Prolaris testing and have a CCR score with estimated DSM risk ≤3.2%.
• Have NCCN low-risk disease2.

Exclusion criteria

• Received any therapy other than 5α-reductase inhibitor (5-ARI) prior to diagnostic biopsy.
• Over 80 years of age at diagnosis.
• History of hypogonadism at the time of diagnosis.
• Co-occurring malignancy, excluding non-melanoma skin cancer.
• Enrolled in another investigational study.