About 15-17% of the prostate cancer population have been identified as having germline mutations. Genomic evaluation has identified more than 100 genes contributing to the risk of prostate malignancy. However, their cancers' clinical course and aggressiveness do not seem to differ. On average, these patients are diagnosed 6 to 7 years earlier than the general population. A small subset of patients with prostate cancer has a hereditary form of the disease. Though the exact etiology is unknown, genetic predisposition and family history are clearly associated with an increased risk of prostate cancer. Sixty-six percent of cases diagnosed are older than 65 years, and the average age of initial diagnosis is 66 years. Even though prostate cancer mortality has relatively less variation worldwide, the rates are exceptionally high among the Black population in the Caribbean and sub-Saharan Africa, intermediate in the US, and lowest in South Central Asia.
The incidence of prostate malignancy has a geographical variation, with the highest in Australia/New Zealand, North America, and parts of Europe, primarily due to the employment of prostate-specific antigen (PSA) testing and an aging population. However, 5-year relative survival is estimated to be 98.6%. It accounts for 14% of all new cancer diagnoses and 5.7% of cancer mortalities annually. In the US, the SEER (Surveillance, Epidemiology, and End Results) database estimated about 268,490 new cases and 34,500 deaths due to prostate malignancy in 2022. The International Agency for Research on Cancer (IARC) estimates that 1,414,259 new cases of prostate cancer are diagnosed worldwide yearly, resulting in a mortality of 375,304. This activity reviews the current status of the available risk-stratification biomarkers and those undergoing investigation. Prostatic risk stratification biomarkers are intended for use primarily in lower-risk and selected borderline patients with marginally elevated PSA levels (typically 4 ng/mL to 10 ng/mL) where an adverse finding would likely result in the avoidance of immediate further testing, prostatic imaging, biopsies, or other diagnostic procedures. In addition, it would have a high negative predictive value of at least 90%, be FDA (Food and Drug Administration) and CLIA (Clinical Laboratory improvement amendments) approved, and be recommended by the National Comprehensive Cancer Network (NCCN.) Such validated surrogate biomarkers can often prevent patients from undergoing lengthy clinical trials, unnecessary biopsies, expensive imaging tests, or other invasive tissue diagnostics to ascertain the clinical benefit of the therapy.Īn ideal biomarker should be highly sensitive and specific, easy to use and interpret, cost-effective, readily available, reproducible, and quantifiable from an easily extractable specimen. In this way, a biomarker can track the effectiveness of a treatment for a specific disease or condition. Instead of a clinical endpoint, surrogate biomarkers can potentially evaluate a particular patient's response to a new drug, procedure, or therapy and determine its utility for that individual. Several commercial risk-stratification biomarkers for patients with persistently elevated PSA levels and suspected prostate cancer are now available. These biomarkers could be proteins, DNA, mRNA, metabolites, prostate cancer cells or derivatives, exosomes, or measurements of various cell cycle processes like cellular proliferation or apoptosis. The Early Detection Research Network (EDRN) is the National Cancer Institute's initiative to identify, develop and validate future biomarkers and newer technologies for earlier and more accurate cancer diagnosis. When properly utilized, Biomarkers enable healthcare professionals to tailor various diagnostic modalities to the patient while avoiding unnecessary diagnostic procedures and overtreatment. It is a marker of an unhealthy process, condition, or disease. According to the National Cancer Institute (NCI), a biomarker is a biological molecule detected in blood, urine, other body fluids, or tissues. One of the best ways to screen, diagnose, stage, assess therapeutic response, and predict prostate cancer is to use various biomarkers in the serum or urine. However, due to the usually indolent course of the disease, the mortality rate is only 1 in 41 diagnosed men. One in eight men is estimated to develop prostate cancer during his lifetime. It is the second most commonly diagnosed malignancy and the fifth leading cause of cancer-related deaths in men. Prostate cancer is one of the most frequently detected cancers n males, comprising approximately 1.4 million cases worldwide.
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