New data shows ProMark accurately predicts aggressive prostate cancer, pathology outcomes
ProMark has potential to transform prostate cancer care by aiding doctors and patients with appropriate treatment assessment
CAMBRIDGE, Massachusetts, June 2, 2014 – Today, for the first time, Metamark presents results from the clinical validation study that showed ProMark™, the first and only proteomic-based imaging biopsy test, achieved its primary endpoint by accurately differentiating between aggressive and non-aggressive forms of prostate cancer at early stages of disease. ProMark™ was shown to predict which patients have low-risk disease with a sensitivity of 90 percent or better, confidently identifying patients who are appropriate for active surveillance or need aggressive therapy. The data is being presented at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO).
"These results reinforce ProMark™ as a critical tool that has the potential to improve prostate cancer care by fulfilling the unmet need for more precise prognostic testing, which may benefit a significant number of the more than 200,000 men in the U.S. diagnosed annually who may be appropriate for active surveillance," said Fred Saad, M.D., F.R.C.S., Professor and Chief, Division of Urology, Director of Urologic Oncology, University of Montreal Hospital Center. "ProMark™ offers the oncology healthcare community a novel prognostic option to help confidently differentiate patients with more aggressive cancers from those with less aggressive disease, thereby enabling more personalized treatment decisions for our patients."
The results being presented are a culmination of three clinical studies. The first study identified 12 biomarkers that predicted both lethal outcome and prostate cancer pathology, and of those, eight were targeted in a clinical development biopsy study as the final subset for the ProMark™ test.
The third, blinded clinical validation study of ProMark™, which analyzed 274 prostate cancer biopsies, accurately predicted the overall prostate cancer pathology for patients with biopsy Gleason grades of 3+3 (=6) or 3+4 (=7). Quantitative measurements on the biopsy samples allowed researchers to successfully identify ProMark™ risk scores for 'favorable' cases (surgical Gleason score 3+3 or 3+4; organ-confined disease [=4+3), more likely in need of aggressive therapy, with an AUC of 0.69 (0.61-0.74; p END
"These results reinforce ProMark™ as a critical tool that has the potential to improve prostate cancer care by fulfilling the unmet need for more precise prognostic testing, which may benefit a significant number of the more than 200,000 men in the U.S. diagnosed annually who may be appropriate for active surveillance," said Fred Saad, M.D., F.R.C.S., Professor and Chief, Division of Urology, Director of Urologic Oncology, University of Montreal Hospital Center. "ProMark™ offers the oncology healthcare community a novel prognostic option to help confidently differentiate patients with more aggressive cancers from those with less aggressive disease, thereby enabling more personalized treatment decisions for our patients."
The results being presented are a culmination of three clinical studies. The first study identified 12 biomarkers that predicted both lethal outcome and prostate cancer pathology, and of those, eight were targeted in a clinical development biopsy study as the final subset for the ProMark™ test.
The third, blinded clinical validation study of ProMark™, which analyzed 274 prostate cancer biopsies, accurately predicted the overall prostate cancer pathology for patients with biopsy Gleason grades of 3+3 (=6) or 3+4 (=7). Quantitative measurements on the biopsy samples allowed researchers to successfully identify ProMark™ risk scores for 'favorable' cases (surgical Gleason score 3+3 or 3+4; organ-confined disease [=4+3), more likely in need of aggressive therapy, with an AUC of 0.69 (0.61-0.74; p END