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Diagnosis of Gleason 6 prostate cancer can leave uncertainty about the presence of undetected aggressive disease. To reduce overdiagnosis and overtreatment of indolent disease, a noninvasive and easy-to-administer test is needed to better stratify risk in patients with clinically insignificant disease. For men on active surveillance, such an assay must also be able to help accurately inform whether a prostate biopsy is warranted, and it must be able to more closely monitor patients with non-aggressive disease. Objective: To evaluate the performance of a novel, serum-based multiplexed autoantibody assay plus age versus PSA for discriminating high-grade prostate cancer (Gleason Score 7 or greater) from Gleason 6 among patients who have positive biopsies. Methods: Using retrospective serum samples, the autoantibody assay results were compared with biopsy outcomes in 377 patients (an autoantibody-binding peptide discovery study of 146 samples, a training set of 231 total samples (90 + 141) and a validation cohort comprised of approximately 1/3-2/3 1000X protocol involving a total of 231 samples (90 + 141)) with prostate cancer (Gleason 6 or greater). Samples were sourced from two academic sites and one community clinical facility in the United States. Eligible participants included men aged 40 years or older undergoing a prostate biopsy due to suspicious digital rectal examination finding and/ or elevated PSA level. Results: Among the 377 men (median age 63.2 years; median PSA 7.4 ng/mL), the autoantibody assay plus Age showed better discrimination (Area Under the Curve (AUC) 0.83, 95% CI 0.76-0.90) than PSA alone (AUC 0.60, 95% CI 0.52-0.68) (P =0.001) for separating Gleason Score 7 or greater from Gleason Score 6 in prostate cancer positive patients. For detected Gleason Score 7 or higher test with 95% sensitivity, 24.4% of total biopsies could have been avoided, missing only 3.9% or six (6) patients with Gleason Score 7 disease. Of these six (6) patients whose cancers were missed, a sub-analysis revealed five were Gleason 7 (3+4) and only one was Gleason 7 (4+3). Conclusion: This study evaluated a novel, cancer-specific biomarker assay based on autoantibody signatures that could be used as a noninvasive risk assessment aid for men with non-aggressive disease who are not receiving treatment. When results of this assay are combined with traditional clinical risk factors, risk stratification for high-grade prostate cancer and biopsy decision making are improved compared to current methods in clinical practice. We hypothesize patients with Gleason Score 6 will exhibit the greatest benefits from employing the assay as they may likely avoid both unnecessary prostate biopsy and subsequent overtreatment. We further hypothesize the assay will thus significantly reduce costs to the healthcare system while further improving patient’s quality of care. Providers and their patients diagnosed with indolent prostate cancer may consider using this novel assay prior to proceeding with prostate biopsy or other treatments. Correspondence to: Amanda L. Fish, MBA, CPHQ, Global Leader, Key Opinion, Leader Engagement and Strategic Partnerships, Armune BioScience, Inc., USA, Tel: 404.308.4682; E-mail: Amanda.Fish@Armune.com Received: October 01, 2017; Accepted: October 18, 2017; Published: October 21, 2017 Introduction Low risk and many cases of low-intermediate risk prostate cancer are indolent, have little or no metastatic potential, and do not pose a threat to the patient in his lifetime [1]. Active Surveillance is increasingly accepted as a treatment option for favorable-risk prostate cancer as it may reduce the risk of overtreatment of clinically insignificant prostate Wang X (2017) Improved risk assessment using a novel cancer-specific biomarker assay derived from autoantibody signatures for men with non-aggressive prostate cancer who are not receiving treatment Volume 1(1): 2-6 Biomed Res Rev, 2017 doi: 10.15761/BRR.1000103 cancer while retaining the option for definitive therapy for patients who are reclassified over time as higher risk [2]. Active surveillance protocols have evolved in recent years. There are variations between the protocols of different institutions, and a standardized protocol does not yet exist. The principle modality of active surveillance follow-up is a combination of serial prostatespecific antigen (PSA) measurements and digital rectal exams (DRE). An unmet need among physicians and patients using the active surveillance approach has been a means of avoiding the 25% to 30% risk of misclassification inherent in a systematic biopsy-based diagnostic strategy [1]. Given variation among the recommendations and associated controversy with PSA-based prostate cancer screening, clinicians are encouraged to balance harms and benefits from screening to prevent negative physical and psychological side effects from diagnosis and therapy [3]. Whilst PSA remains the first-line biomarker option for the detection of prostate cancer, significant research efforts on novel serum, urine and tissue biomarkers to identify patients at risk for intermediateor high-risk prostate cancer are underway. However, unlike the serum-based novel multiplexed autoantibody assay described herein, many of these other biomarkers are based in some way on measurement of PSA [4]. Following a prostate cancer diagnosis, patients are faced with a multitude of care options, the advisability of which is influenced by patient factors and by cancer severity or aggressiveness. The ability to categorize patients based on cancer aggressiveness is invaluable for facilitating care decisions. Recently, the American Urological Association (AUA) in conjunction with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO) issued guidelines recommending active surveillance for patients for very low-risk and most low-risk localized prostate cancer patients [5]. That said, a novel autoantibody assay that can assist in the assessment of cancer severity and subsequent risk group would likely be clinically useful. Building on the advances in genomics and proteomics, and specifically the discovery that patients with cancer produce detectable autoantibodies against antigens in their tumors, suggests that these biomarkers could have diagnostic and prognostic value [6]. Researchers have identified a panel of eight peptides that are recognized by autoantibodies generated by the immune system in response to the presence of prostate cancer, and developed an algorithm that can be used to indicate a relatively high or low risk of prostate cancer, particularly for patients with intermediate (4.0 to 10 ng/mL) PSA levels [4]. These cancer-specific, non-PSA blood tests known as Apifiny® and Apifiny® PRO in a variety of clinical studies [4,7] have provided insights into the presence and aggressive prostate cancer risk in patients being considered for initial or repeat biopsy. The aim of this study was to validate the performance of this expanded serum-based multiplexed autoantibody assay in the risk stratification of men with non-aggressive disease who are not receiving treatment. Thus, researchers examined the performance of the 8 Apifiny® peptides when used in combination with an extended set of up to 13 new autoantibody-binding peptides plus age compared to PSA in discriminating high-grade prostate cancer (Gleason Score 7 or greater) from Gleason 6 among patients who have positive biopsies [8]. Materials and methods

biomedical research and reviews

Improved risk assessment using a novel cancer-specific biomarker assay derived from autoantibody signatures for men with non-aggressive prostate cancer who are not receiving treatment