[21] This multicenter international cohort included 5,302 patients with low-risk prostate cancer managed with active surveillance. Radical prostatectomy and radiation therapy, the standard treatments for prostate cancer, both frequently result in significant adverse events, including urinary and erectile dysfunction. 2016;13:205-15. The hallmarks of cancer include six biological capabilities that are typically acquired by human tumors during their development: 1) sustained proliferative signaling, 2) activation of local invasion and metastasis, 3) induction of angiogenesis, 4) evasion of growth suppressors, 5) resistance to cell death, and 6) unlimited replicative potential. Gleason pattern 3 disease (Gleason score 6, now known as Gleason grade group 1) does not metastasize. Lin K, Croswell JM, Koenig H, et al. 2014;33:930-9. 6. Data from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry demonstrates the increase in the use of active surveillance for patients with low-risk prostate cancer-from a low of 6.7% in the years from 1990 to 2009, to 40.4% in the period 2010 to 2013. J Clin Oncol. Active surveillance has emerged as a conservative approach that can mitigate overtreatment. Lancet Oncol. In contrast, those with a large prostate volume relative to their PSA level can be reassured that they are less likely to harbor aggressive disease. Catalona WJ, Smith DS, Ratliff TL, et al. Men with prostate cancer that has a very low risk of growing quickly or spreading may be offered active surveillance. Intermediate and longer-term outcomes from prospective active surveillance program for favorable-risk prostate cancer. Also, a small group of patients have molecular alterations that can cause progression to more aggressive disease; these men can be switched to immediate treatment if such progression is detected. Decipher genomic classifier measured on prostate biopsy predicts metastasis risk. Tosoian JJ, Mamawala M, Epstein JI, et al. In their molecular genetics, most Gleason pattern 3 cells resemble normal cells. https://www.nice.org.uk/guidance/cg175/resources/protocol-for-active-surveillance-19674477. 33. Active surveillance for prostate cancer This leaflet aims to answer any questions you may have about active surveillance (monitoring) of your prostate cancer. Ahmed H, Arya M, Emberton M, et al. Urology. According to the American Cancer Society, in 2016 an estimated 180,890 new cases of prostate cancer were diagnosed in the United States, making this disease the most common solid tumor in men. Many men diagnosed with prostate cancer don’t need to be treated right away. 2008;22:389-402. 2011;144:646-74. Active surveillance for the management of localized prostate cancer. All rights reserved. It is characterized by a routine protocol of close monitoring with digital rectal examination, periodic biopsy, and serial PSA testing. 2016;119:535-42. The high negative predictive value is particularly important in this population, and this figure has been confirmed by many groups. They have been agreed by our Expert Reference 2001;85:576-83. 2013;105:1050-8. Thirty percent of patients with newly diagnosed low-risk prostate cancer have an occult higher-grade cancer. Prostate cancer: protocol for active surveillance. 7. Correlation of vascular endothelial growth factor expression with fibroblast growth factor-8 expression and clinico-pathologic parameters in human prostate cancer. Reflecting this approach, the NCCN guidelines make a distinction between very-low-risk disease (defined as fulfilling the Epstein criteria), for which active surveillance is the recommended strategy, and low-risk disease (Gleason score of 6 but higher volume of cancer on biopsy), for which all therapies, including surgery and radiation, are considered options. Nat Rev Urol. Klein EA, Haddad Z, Yousefi K, et al. Financial Disclosure:The authors have no significant financial interest in or other relationship with the manufacturer of any product or provider of any service mentioned in this article. Oncology (Williston Park). In order to understand the natural history of surgically treated Gleason 6 prostate cancer, Eggener et al[17] conducted a multicenter study of 24,000 men with long-term follow-up. Klotz et al offered active surveillance to some men with a Gleason score ≤ 3+4 and/or a PSA level of 10 to 20 ng/mL, and with a life expectancy of less than 10 years. • What interventions (diet, exercise, micronutrients, pharmacologic agents) are able to reduce the risk of biological progression in men on active surveillance, and thus are warranted? Future research goals will be to integrate and correlate information obtained through multiparametric MRI and results of genomic biomarker assays. The caveat is that younger patients have a longer period of time in which to develop biological progression to higher-grade cancer. Urology. 2011;185:869-75. Zlotta et al[10] confirmed this hypothesis when they prospectively compared tissue obtained during autopsy from prostate glands in both a Caucasian and an Asian population. 37. If you have low risk prostate cancer, Active Surveillance is increasingly being recommended as a management option for your disease, in order to avoid unnecessary and invasive treatments when it is clinically safe to do so. The effect of the USPSTF PSA screening recommendation on prostate cancer incidence patterns in the USA. Over 30% of men have prostate cancers that are so slow growing and “lazy” that Active Surveillance is a better choice than immediate local treatment with surgery or radiation. Clinical and molecular data support the absence of a metastatic phenotype for Gleason pattern 3 cancers. It is characterized by a routine protocol of close monitoring with digital rectal examination, periodic biopsy, and serial PSA testing. Active surveillance is a plan to monitor low and some intermediate-risk, localized prostate cancer. 22. Do low-grade and low-volume prostate cancers bear the hallmarks of malignancy? Any Gleason pattern 4 disease at baseline is associated with a significant increase in the risk of progression to metastatic disease. 4. After 18 years of follow-up, overall mortality and prostate cancer–specific mortality rates were higher in patients managed with watchful waiting than in those who received immediate treatment. Active surveillance is often recommended for low-risk prostate cancer (or intermediate-risk disease). Inoue LY, Trock BJ, Partin AW, et al. In contrast, according to the Cancer Care Ontario and ASCO guidelines, all men with low-risk prostate cancer are candidates for surveillance.[27,28]. Only 1 patient in the cohort died of prostate cancer; a pathology review reported Gleason 4+3 disease in this man instead of what was initially thought to be Gleason 3+3=6 disease. In those patients with an increase in prostate cancer volume or a new biopsy showing Gleason 3+4 disease but who still desire surveillance as a management option, and in those whose PSA doubling time is < 3 years, a multiparametric MRI should be performed. [4] The active surveillance strategy aimed to diagnose, observe, and act with the intention to cure only when essential. This is the decision to not treat prostate cancer right away, but instead to watch it closely. Active surveillance is a conservative management approach, conducted for those patients with "low-risk" or "favorable-risk" disease, which avoids long-term adverse effects on the patient's quality of life. Eggener SE, Scardino PT, Walsh PC, et al. 2017; 31(5):333-40, 345 (ISSN: 0890-9091) Garisto JD; Klotz L. Prostate cancer … 2015;113:382-9. There are variations in eligibility criteria and follow-up strategy, however. 44. The best estimate of the likelihood of grade progression (as distinct from disease reclassification due to more accurate or repeat sampling) is 1.2% to 2% per year. 2015;193:807-11. Oncologic outcomes for active surveillance cohorts have shown the long-term safety of this approach, with a cancer-specific mortality rate of 3% at 10 to 15 years. Gleason scores less than 7 are considered lower risk and might be appropriate for active surveillance. There has been a nearly 70% increase in new prostate cancer cases, mostly classified as low risk, that have been diagnosed in early stages as a consequence of prostate-specific antigen (PSA) screening. As defined by D'Amico, active surveillance is broadly appropriate for men with a Gleason score of 6 or less and a PSA level of less than 10 ng/mL. Novel tools to improve patient selection and monitoring on active surveillance for low-risk prostate cancer: a systematic review. Who Should Receive Active Surveillance in Prostate Cancer? [5] Over the following 10 years, more than 90% of patients with low-risk prostate cancer were managed with radical therapies (radical prostatectomy or radiation). 11. The prostate is a small gland located below the bladder and in front of the rectum in men. Typically, Gleason pattern 3 disease lacks the common genetic aberrancies of a true cancer. 15. • Can risk stratification allow some patients to minimize the burden of follow-up? Bokhorst LP, Valdagni R, Rannikko A, et al. 25. 2015;68:123-31. [30] These are summarized in Table 3. The principle modality of active surveillance follow-up is a combination of serial PSA measurements and DREs. Not surprisingly, the 15-year prostate cancer–specific mortality rate was only 0.4%. Patient-specific meta-analysis of 2 clinical validation studies to predict pathologic outcomes in prostate cancer using the 17-gene genomic prostate score. Active surveillance for the management of localized prostate cancer (Cancer Care Ontario guideline): American Society of Clinical Oncology clinical practice guideline endorsement. 2016;70:954-60. Active Surveillance is risky for Gleason 3+4 prostate cancer. Prostate cancer arises from genetically altered prostate epithelium and slowly progresses over several decades. [22] The second of these large studies was the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) randomized clinical trial. Patients with low-risk prostate cancer should consider active surveillance, as opposed to surgery or radiation, which may be unnecessary, suggests Daniel A. Barocas, MD, lead author of a recently published study in theJournal of the American Medical Association,which compared differences in quality of life among patients who have undergone radical prostatectomy, … 41. [8] Active surveillance has emerged as a conservative approach that can mitigate overtreatment (Figure). 2015;33:3379-85. 1994;8:439-43. on active surveillance, and the role of prostate cancer biomarkers and imaging studies (MRI) for clinical decision making in patients with low-risk disease. However, my biopsy came back with 6 out of 14 cores showing positive for Gleason 6 type prostate cancer. 2015;67:627-36. 2012;367:203-13. In the group with low-risk disease, the metastasis-free survival rate at 10 and 15 years was 96% and 95%, respectively. 46. Also, more than 50% of the cancers in the Asian group had a Gleason score of 7 or greater. 2002;167:1664-9. Considering the slow progress of most prostate cancer, active surveillance is a reasonable choice for many men. Value of 3-Tesla multiparametric magnetic resonance imaging and targeted biopsy for improved risk stratification in patients considered for active surveillance. Steyn JH, Smith FW. Impact of race. 28. Radical treatment should be offered to most patients with upgraded disease. 10. Era specific biochemical recurrence-free survival following radical prostatectomy for clinically localized prostate cancer. [11] Ahmed et al[12] applied these oncologic principles in a review that described the different features of Gleason patterns 3 and 4, and concluded that most small Gleason pattern ≤ 3 lesions could be considered nonmalignant. 2016;195:313-20. Eur Urol. Overdetection trends were sustained until 2012, when the United States Preventive Services Task Force (USPSTF) assigned a grade of “D” to the use of PSA-based screening for prostate cancer (meaning that they recommended against the practice) for men of all ages (the USPSTF had already recommended against PSA-based screening in men aged ≥ 75 years in 2008). The HR of prostate cancer death was 1.7 per unit increase in cell cycle progression score.[47,48]. Eur Urol. The initial dilemma in the management of clinically localized prostate cancer stems from prostate cancer’s heterogeneity, as evidenced by its natural history. Racial variation in prostate cancer upgrading and upstaging among men with low-risk clinical characteristics. Do adenocarcinomas of the prostate with Gleason score <6 have the potential to metastasize to lymph nodes? Multiparametric MRI and biomarkers will likely expand the indications for surveillance-by identifying intermediate-risk patients with favorable-risk disease, and by reassuring low-risk patients that they are not harboring higher-risk cancer. N Engl J Med. NCCN clinical practice guidelines in oncology. [24] Patients randomized to active monitoring had their PSA level measured every 3 months during the first year and every 6 to 12 months thereafter. Wilt TJ, Brawer MK, Jones KM, et al. At 5 and 10 years of follow-up, 52% and 73%, respectively, had discontinued active surveillance. Nat Rev Urol. A risk of active surveillance is that it can give the cancer a chance to grow or spread. Long-term monitoring is based on PSA measurement and DRE every 6 months, with successive prostate biopsies and/or MRI every 3 to 5 years. Thus, in the absence of higher-grade cancer, there is little indication for treatment in most patients. Pessoa et al[41] published the results of a prospective cohort study that enrolled 105 patients with low-risk, low-grade, localized prostate cancer who were candidates for active surveillance; the men subsequently underwent multiparametric MRI. Prevalence of prostate cancer on autopsy: cross-sectional study on unscreened Caucasian and Asian men. 20. 47. 1982;54:679-81. 2. Radical prostatectomy versus observation for localized prostate cancer. J Natl Cancer Inst. 10-Year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. Pessoa RR, Viana PC, Mattedi RL, et al. Gleason patterns 3 and 4 are dramatically different genetically. 8. This epidemiologic phenomenon resulted in the overdetection and overtreatment of insignificant disease, raising the risk of unnecessary morbidity and impairment of men’s health-related quality of life. Evidence indicates that these genomic assays can detect the presence of molecular alterations associated with higher-grade cancer on biopsies that demonstrate microfocal Gleason 6 disease. Eur Urol. [20] A total of 1,298 men were included in this cohort; the median follow-up was 5 years. There has been a nearly 70% increase in new prostate cancer cases, mostly classified as low risk, that have been diagnosed in early stages as a consequence of prostate-specific antigen (PSA) screening. Further, “active monitoring,” while more intensive than “watchful waiting,” did not include serial biopsies or predefined indications for intervention. 32. 13. Active surveillance is often used to mean monitoring the cancer closely. Active Surveillance for prostate cancer What is prostate cancer? [Epub ahead of print]. N Engl J Med. 2001;166:416-9. Cuzick J, Berney DM, Fisher G, et al. 2010;28:126-31. Active Surveillance for Prostate Cancer: How to Do It Right. Prostate Cancer Prostatic Dis. J Clin Oncol. [40] A combination of conventional anatomical and functional MRI is known as multiparametric MRI. Active surveillance protocols have evolved in recent years. Similarly, advances in genetic analysis have led to the discovery of new biomarkers that may predict outcomes of prostate cancer and response to therapy. [25] Currently, definitive criteria for the selection of patients for active surveillance are lacking. • Can the widespread adoption of surveillance for low-risk disease rehabilitate prostate cancer screening? [3] The rapid adoption of PSA screening in North America and Europe dramatically increased the incidence of prostate cancer that was identified, much of which was microfocal low-grade disease. J Urol. Validation of an RNA cell cycle progression score for predicting death from prostate cancer in a conservatively managed needle biopsy cohort. © 2021 MJH Life Sciences™ and Cancer Network. Morash C, Tey R, Agbassi C, et al. PSA screening caused an increase in newly diagnosed cases of low-risk prostate cancer, leading to overtreatment. COPYRIGHT © 2002 - 2021 DIGITAL SCIENCE PRESS, INC. Login to update email address, newsletter preferences and use bookmarks. Young age has not been demonstrated to be a risk factor for progression. J Urol. Almost 80% of cases are detected at clinically localized stage III,[3] and more than half are expected to be low-risk tumors. Active surveillance now represents the primary treatment recommended in evidence-based guidelines for most men with low-risk prostate cancer. [9] Given its features of multifocality and tumor heterogeneity, the course of prostate cancer is difficult to predict. Radical prostatectomy or watchful waiting in early prostate cancer. Eur Urol. While confidence in conservative management for low-risk disease has increased significantly as the cohorts have matured, many unanswered questions remain. Brand TC, Zhang N, Crager MR, et al. Recently, the Prostate Cancer Research International Active Surveillance (PRIAS) study reported data after 10 years of follow-up. BJU Int. Sundi D, Faisal FA, Trock BJ, et al. 30. National Institute for Health and Care Excellence. Version 2.2017. https://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. 48. 31. 2015;67:451-7. Further investigation is needed to determine progression factors in this subgroup of patients with Gleason 7 prostate cancer. 2015;85:155-60. This likely reflects the fact that 25% of the cohort had intermediate- or high-risk disease, for which conservative management is clearly associated with an increased risk of progression. Newcomb LF, Thompson IM Jr, Boyer HD, et al; Canary PASS Investigators. Advanced Prostate Cancer Consensus Conference (APCCC), American Society of Clinical Oncology (ASCO), ANZUP Mini Annual Scientific Meeting (ASM), European Society for Medical Oncology (ESMO), International Bladder Cancer Network (IBCN), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), International Kidney Cancer Symposium (IKCS), A Step Towards Personalized Medicine: PSMA PET Imaging in Prostate Cancer, Contemporary Treatment Strategies For Androgen Deprivation Therapy In Prostate Cancer, COVID-19 and Genitourinary Cancers Videos, Large Urology Group Practice Association (LUGPA), Precision Medicine: PSMA Targeted Therapies in Progressive Metastatic Prostate Cancer Videos, Advances in Nuclear Medicine, PET, and Theranostics, Cardiovascular Disease in Men with Prostate Cancer, Nocturia & Lower Urinary Tract Conditions, 2021 European International Kidney Cancer Symposium (EIKCS), http://www.ncbi.nlm.nih.gov/pubmed/28512731. Br J Cancer. [19] This single-arm cohort study included 993 men, 740 with low-risk disease (Gleason score ≤ 6 and serum PSA level ≤ 10 ng/mL) and 253 with intermediate-risk disease (serum PSA ≤ 15 ng/mL or a Gleason score of 7 [3+4]) who had significant comorbidity or a life expectancy of less than 10 years. With AS being offered more often and more patients being included in AS studies, the aim of this paper is to describe AS from a legal perspective. This is a 22-marker genomic test that is based on RNA expression and that utilizes tissue from a prostate biopsy. Br J Cancer. An additional series from the Hopkins pathology group examined cases with a Gleason score of ≤ 6 from radical prostatectomy databases from four large academic centers. Application of the Epstein criteria for prediction of clinically insignificant prostate cancer in Korean men. Predicting 15-year prostate cancer specific mortality after radical prostatectomy. This is because most prostate cancers grow slowly and are unlikely to spread outside of the prostate. “There’s no one way to select candidates for active surveillance,” says urologist and molecular biologist Chris Barbieri, M.D., Ph.D., who treats men with all kinds of prostate cancer and works with several hundred patients currently on active surveillance. The article is written by Garisto and Klotz. Active surveillance in younger men with prostate cancer. There were no differences with respect to risk of definitive treatment or risk of biochemical recurrence after delayed radical prostatectomy. This prospective study compared radical prostatectomy vs watchful waiting in early prostate cancer. • How can we optimally identify the  “wolves in sheep’s clothing”-ie, those low-grade cases that harbor higher-grade cancer? After 20 years of experience with this approach, active surveillance has become widely adopted around the world. 2017 May 15 [Epub], PubMed http://www.ncbi.nlm.nih.gov/pubmed/28512731. 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. There was a difference in the metastasis rate favoring radical treatment. J Clin Oncol. Because of the very favorable experience with active surveillance in Gleason 6 cancer, and the significantly higher rate of progression seen with Gleason 7 disease, most groups now take a middle-of-the-road approach, offering active surveillance to most patients with Gleason 6 disease regardless of cancer volume, and being very selective about offering it to patients with Gleason 7 disease. [36] Finding small amounts of low-grade cancer in a young man in no way means that his disease is destined to progress to significant cancer. For example, the Johns Hopkins program used stringent eligibility criteria, according to which inclusion is based on the Epstein criteria for clinically insignificant prostate cancer (PSA density < 0.15 ng/mL/cm3, Gleason score ≤ 6, ≤ 2 positive biopsy cores, and ≤ 50% involvement of any biopsy core). As of the publication of this article, the three genetic tissue assays described below have been cleared by the US Food and Drug Administration for use in men with prostate cancer. If you are eligible for active surveillance and decide to enroll in this approach, you will work with your doctor and your family to develop a plan that includes regular checkups and tests over time. Zlotta AR, Egawa S, Pushkar D, et al. Active surveillance is a conservative management approach, conducted for those patients with “low-risk” or “favorable-risk” disease, which avoids long-term adverse effects on the patient’s quality of life. Tosoian JJ, Carter HB, Lepor A, Loeb S. Active surveillance for prostate cancer: current evidence and contemporary state of practice. For example, “frequent transrectal ultrasound on active surveillance doesn’t really help” do anything except pad the doctor’s bottom line, rather than serve the patient’s best interests. Active surveillance for prostate cancer is firmly in the mainstream of cancer treatment. Wei JT, Dunn RL, Sandler HM, et al. 39. van den Bergh RC, Ahmed HU, Bangma CH, et al. Eur Urol. Cullen J, Rosner IL, Brand TC, et al. ERG protein expression in diagnostic specimens is associated with increased risk of progression during active surveillance for prostate cancer. The first study of active surveillance was started by researchers at the University of Toronto in 1996. There are variations between the protocols of different institutions, and a standardized protocol does not yet exist. Active Surveillance has been shown to be a safe option for men with low risk prostate cancer to either avoid or delay the need for treatment. Extended follow-up and risk factors for disease reclassification in a large active surveillance cohort for localized prostate cancer. [Epub ahead of print]. It was first described in 2002 in a report of 206 patients managed with periodic prostate biopsies and serial PSA testing, with radical intervention recommended for patients reclassified as higher risk. The molecular and histologic patterns of Gleason 3 lesions are likely predetermined to remain stable or even involute. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. The genomic classifier test had an independent predictive value on multivariable analysis for predicting metastasis following prostatectomy, with a hazard ratio (HR) of 1.5 for each 10% increase in score; these results were validated in two separate prostatectomy cohorts. [37] A recent study evaluated the association of age with various active surveillance endpoints. Request PDF | Active Surveillance for Prostate Cancer: How to Do It Right | Prostate cancer is the most common malignancy affecting men. Active surveillance is an approach whose intention is to diminish the morbidities of immediate active treatment for men with low-risk prostate cancer who likely will never develop cancer-related symptoms. J Urol. These excellent results are explained by the more rigorous active surveillance eligibility criteria used by this group. Active Surveillance for prostate cancer – is it right for you? In the group with intermediate-risk disease, the metastasis-free survival rate was 91% and 82% at 10 and 15 years, respectively. Multiparametric MRI is becoming part of the management of patients with localized prostate cancer as a result of these data.[42]. While conservative management aims to reduce the burden of invasive testing without compromising oncological safety, inadequate assessment can result in … Study authors hope new findings increase appeal of disease monitoring and reduce patient and provider anxiety. 45. Urology. 18. Lastly, the Prostate Testing for Cancer and Treatment (ProtecT) trial compared three modalities of management-active monitoring, radical prostatectomy, and external-beam radiotherapy-in patients with localized prostate cancer. Data regarding the natural history of this disease confirm the clinical insignificance of low-grade prostate cancer, which is associated with scant or no metastatic dissemination. Hallmarks of cancer: the next generation. Leapman MS, Freedland SJ, Aronson WJ, et al. [6] Subsequent to this recommendation, rates of PSA screening decreased by 3% to 10% in all age groups, followed by a shift toward detection of tumors of higher grade and stage. 40. In the Sakr autopsy series, 29% of men in their 30s harbored microfocal Gleason 6 cancer. 42. 2016;90:148-52. Debating the Frequency of Biopsy in Monitoring Low-Risk Prostate Cancer. [31] Essentially this means that patients with a high PSA level relative to their prostate volume are at increased risk, and should be scrutinized very carefully before being placed on surveillance. Prostate cancer was found in a similar proportion (35%) of men in both groups. A 20-point increase in the “genomic prostate score” is associated with a statistically significant increased risk of high-grade and/or non–organ-confined disease (odds ratio, 1.9; 95% CI, 1.3–2.9). 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