Beckman Coulter’s <i>phi</i> Named in NCCN Guidelines as a Recommended Diagnostic Test for Early Prostate Cancer Detection

Beckman Coulter's Prostate Health Index (phi)* has been recommended by the National Comprehensive Cancer Network (NCCN) as a blood test to improve specificity for prostate cancer detection in its recently updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer Early Detection. Inclusion in the NCCN Guidelines recognizes the benefit and clinical utility of phi for better prostate cancer diagnosis and for the reduction of unnecessary biopsies.

"It is exciting to see phi recommended in the NCCN Guidelines. I started offering phi to my patients this year and it has proven to be a valuable addition to our shared decision making process," said William Catalona, MD, principal investigator on the Prostate Health Index clinical study, and urologist at Northwestern Medicine and director of the Clinical Prostate Cancer Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago.

Approved for use by the FDA in men with PSA values between 4 and 10 ng/mL, the Prostate Health Index (phi) is a simple, non-invasive blood test that is three times more specific in detecting prostate cancer1 than PSA alone, decreasing the need for many men with elevated PSA levels to undergo a biopsy in order to achieve a reliable diagnosis.

Following the initial testing to detect prostate cancer — PSA and digital rectal exam (DRE) — the guidelines recommend the use of phi to further define the probability of cancer before undergoing biopsy or a repeat biopsy.2 It is recommended that tests which improve specificity, such as phi, be considered for patients who have a higher risk of cancer, despite a negative biopsy.3 The new version of the guidelines is designed to reduce unnecessary testing and over-diagnosis.

"The NCCN provides physicians with useful guidelines for prostate cancer detection and treatment," said Dr. Stacy Loeb, assistant professor at the Department of Urology and Population Health at NYU Langone Medical Center in New York City and phi pivotal study investigator. "The inclusion of phi addresses the need for a test with increased specificity for clinically significant prostate cancer."

NCCN, a not-for-profit alliance of 25 of the world's leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.

* The Prostate Health Index is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA 4.0 to 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.

1 Beckman Coulter U.S. Prostate Cancer Pivotal Study Report
2 NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer Early Detection. Version 1.2014 (PROSD-3)
3 NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer Early Detection. Version 1.2014 (PROSD-4)