A new molecular test from bioTheranostics, San Diego—the Prostate Cancer Index—is a strong predictor of prostate cancer recurrence and may improve upon the current standard of care for assessing risk of recurrence and metastasis in patients with prostate cancer, according to a study published online in the Proceedings of the National Academy of Sciences.
The Prostate Cancer Index (PCI), currently in development, is a 32-gene signature designed to predict prostate-specific antigen (PSA) recurrence. In the study, conducted in collaboration with Massachusetts General Hospital, the PCI was validated in an independent, blinded set of 270 radical prostatectomy tumor samples.
“In the United States, more than 240,000 men are diagnosed with prostate cancer each year, and it is the second leading cause of cancer mortality in men,” says Richard Ding, CEO, bioTheranostics, adding that the validation study, which strongly supports the use of PCI as a prognostic molecular marker for prostate cancer recurrence, is important because the management of prostate cancer is challenging due to the variable nature of the disease. “Our new PCI test may help physicians make post-operative treatment selections, and has the potential to impact decision-making at the biopsy stage, where patients and physicians must weigh the benefits of currently available therapies against the potential morbidity of the treatments.”
Results showed that the PCI was prognostic for risk of PSA recurrence and had added value over standard clinical prognostic markers such as Gleason score, pathologic tumor stage, surgical margin status, and presurgery PSA levels (P = 0.0057), according to the company. Surgical margin status was the only other factor with significant prognostic value.
The study also showed that the PCI could stratify patients based on the risk of PSA recurrence and the development of metastatic disease. The categories defined by the index significantly stratified patients based on risk of metastasis: the 10-year probability of metastasis was 14% in the high-risk group, and 0% in the low-risk group (P = 0.0006).
Ding said the ability of the PCI to accurately determine the risk of recurrence addresses an important unmet need in the management of prostate cancer. “A key clinical need is to identify patients with slow-growing or aggressive disease to aid in treatment decisions,” he says. “The PCI is the newest test in our suite of molecular diagnostic, prognostic, and predictive tests for cancer that provide valuable information for physicians and patients, helping them to select the right therapy at the right time.”
The study is titled “Development and Validation of a 32-gene Prognostic Index for Prostate Cancer Progression.”