Application

Diagnostic test for predicting the recurrence of prostate cancer following prostatectomy using RNA biomarkers.

Key Benefits

• A panel of twenty-four RNA biomarkers significantly predicts clinical recurrence of prostate cancer after radical prostatectomy.
• Test helps determine if surgery was sufficient or if additional therapies will be needed in treatment of prostate cancer.
• Out-performs other genetic test on the market.
• Biomarker screening can be performed six to eight weeks following prostatectomy.

Market Summary

Prostate cancer is the most common cancer effecting men in the U.S. It is estimated that 1 out of 6 men will be diagnosed with the disease during the span of their life.  If the cancer is localized to the prostate, a prostatectomy is performed. Even with complete removal of the prostate, up to 40% of men will experience recurrence. The standard method for detecting recurrence is blood-based testing for prostate specific antigen (PSA) levels. However, the PSA screen is not accurate in diagnosing prostate cancer or its recurrence. Up to 75% of men with high PSA levels that get a follow up biopsy do not have prostate cancer, while 15% of men with normal PSA levels actually have the disease. A third of men over the age of 65, are over-diagnosed and receive unnecessary treatments as a result of abnormal PSA readings. The PSA test is unreliable because the protein levels increase as men age. PSA levels are also increased in men with benign tumors or infections. A more dependable screen is needed to diagnose prostate cancer and its recurrence.

Technical Summary

Prostate cancer recurrence is detected by screening for prostate specific antigen (PSA) levels. However, PSA testing cannot accurately confirm prostate cancer recurrence, sometimes leading to unnecessary, aggressive treatment. Emory researchers were able to identify a reliable panel of RNA biomarkers that accurately predicts clinical recurrence following prostatectomy. RNA was prepared from 100 prostate cancer patients from three independent sites. Of these patients, 49 had biochemical recurrence and 51 had no recurrence. Genome-wide RNA sequencing was performed on the RNA samples. Quantitative PCR confirmed the validity of the RNA biomarkers identified. Clinical parameters such as the age of the subject, PSA levels before surgery, prostate cancer stage, and a Gleason score was used to develop a clinical predictive score. Together with the gene predictive score, the clinical predictive score was correlated to determine if subjects were at risk of recurrence. The study identified 24 biomarker genes; 22 genes were protein coding genes and two were small RNA genes.

Developmental Stage

Clinical Correlation Data Available