aua guidelines prostate canceraua guidelines prostate cancer

A SEER-based study. (UroToday.com) The 2022 Annual Meeting of the American Urological Association was host to an AUA Guidelines sessions focused on localized prostate cancer, presented by Dr. James Eastham. The Advanced Prostate Cancer Amendment Panel was created in 2022 to review new literature and provide updates to this guideline, where appropriate. Nat Rev Clin Oncol. (Moderate Recommendation; Evidence Level: Grade C), 37. I. No differences were shown for secondary endpoints such as pain scores or performance status or toxicity including ONJ or renal dysfunction. Median MFS was approximately 22 months longer in the enzalutamide arm at 36.6 months compared to 14.7 months in the placebo group (HR=0.29; 95% CI: 0.24 to 0.35; P<0.001). Practical Assessment, Research & Evaluation 2007; Mateo J, Carreira S, Sandhu S et al: DNA-repair defects and olaparib in metastatic prostate cancer. Eur Urol 2022; Moreira DM, Howard LE,Sourbeer KN et al: Predicting time from metastasis to overall survival in castration-resistant prostate cancer: results from SEARCH. In patients with PSA recurrence after failure of local therapy who are at higher risk for the development of metastases (e.g., PSADT <12 months), clinicians should perform periodic staging evaluations consisting of cross-sectional imaging (CT, MRI) and technetium bone scan, and/or preferably PSMA PET imaging. (Clinical Principle), 3. Prostate Cancer: Adjuvant & Salvage Radiotherapy . Abiraterone acetate is an inhibitor of CYP17, and apalutamide, darolutamide, and enzalutamide are second generation antiandrogens. AAFP and USPSTF recommendations for prostate cancer screening: a guideline summary. Purpose: This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options. Guideline Statement 3. Additionally, the patients personal goals of care must be carefully considered when making management recommendations. Articles were published in peer-reviewed journals in or after 1998, though the methodology team included studies published prior to 1998 that were identified from reference lists. (Clinical Principle), There are established laboratory and imaging characteristics known to be associated with prognosis among men with mCRPC. In mCRPC patients, clinicians should obtain baseline labs (e.g., PSA, testosterone, LDH, Hgb, alkaline phosphatase level) and review location of metastatic disease (lymph node, bone, visceral), disease-related symptoms, and performance status to inform discussions of prognosis and treatment decision-making. A PSA response occurred in 35.7% and 13.5% of the patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P=0.004). Clinicians should inform patients with PSA recurrence after exhaustion of local therapy regarding the risk of developing metastatic disease and follow such patients with serial PSA measurements and clinical evaluation. Platinum-based chemotherapy may be offered as an alternative for patients who cannot use or obtain a PARP inhibitor. Platinum-based chemotherapy may be offered as an alternative for patients who cannot use or obtain a PARP inhibitor. Median PFS was significantly prolonged in men treated with enzalutamide when compared with bicalutamide (15.7 months versus 5.8 months for enzalutamide versus bicalutamide, respectively, HR 0.44, 95% CI: 0.34 to 0.57; p<0.0001).116. J Clin Oncol 2000; Pompe RS, Bandini M, Preisser F et al: Contemporary approach to predict early biochemical recurrence after radical prostatectomy: update of the Walz nomogram. All peer review comments were blinded and sent to the Panel for review. FDA approves second PSMA-targeted PET imaging drug for men with prostate cancer. At the end of the 8-month cycle, treatment was discontinued if there was no evidence of clinical disease progression, the PSA level was <4ng/mL, and did not increase more than 1ng/mL. Endocrine 2014; Watts NB, Adler RA, Bilezikian JP et al: Osteoporosis in men: an Endocrine Society clinical practice guideline. BJU Int. As such, sipuleucel-T should only be considered for patients with asymptomatic or minimally symptomatic mCRPC. (Clinical Principle), 8. Given the lack of utility of PSA measurement in this space, the Panel recommends obtaining abdomen/pelvis CT imaging and chest x-ray even in the absence of symptoms prior to cycle four (of planned six monthly cycles) to assess for occult disease progression. The median OS was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling-targeted inhibitor (HR for death=0.64; 95% CI: 0.46 to 0.89; P=0.008). Optimal third line therapy for mCRPC is unknown. An additional pre-specified analysis utilizing the CHAARTED definition of low-volume cancer encompassing 40% of the population was performed. 2018; Hofman MS,Violet J,Hicks RJ et al: [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. In the first phase, methodologists reviewed full-text articles to identify relevant systematic reviews for inclusion. The short range of -radiation reduces the damage to surrounding healthy tissue creating a more localized effect compared to other radionuclide therapies, such as strontium-89. By definition, Grade A evidence is evidence about which the Panel has a high level of certainty, Grade B evidence is evidence about which the Panel has a moderate level of certainty, and Grade C evidence is evidence about which the Panel has a low level of certainty.38, Table 2: Strength of Evidence Definitions. In the double-blind, phase III ARCHES trial, Armstrong et al. For evaluation of treatments, inclusion was restricted to randomized trials, with the exception of studies on sequencing of therapies for which cohort studies were also included. demonstrated that docetaxel improved survival and quality of life (QOL) for such patients with mCRPC.15,16 Since the approval of docetaxel, multiple additional agents that show a survival benefit have been FDA-approved on the basis of randomized controlled trials (RCTs).17-21 These agents have been tested in multiple "disease states" of mCRPC, both before and after docetaxel chemotherapy, to determine when patients might benefit from each treatment. J Clin Oncol 2018; Goodall J,Mateo J,Yuan W et al: Circulating cell-free DNA to guide prostate cancer treatment with PARP inhibition. Studies may be missing information, making it difficult to assess limitations and potential problems. (Strong Recommendation; Evidence Level Grade A), 23. N Engl J Med 2005; Lassemillante AC, Doi SA, Hooper JD et al: Prevalence of osteoporosis in prostate cancer survivors: a meta-analysis. 18F-Fluciclovine is available and approved for patients for whom local therapy fails to control disease. randomly assigned 1,150 men with mHSPC in a 1:1 ratio to receive either enzalutamide (160mg per day) or placebo. Analysis at longer follow-up demonstrated the median survival advantage improved slightly to 19.2 months compared to 16.3 months (P=.004).130 No significant survival differences were noted between the weekly docetaxel plus prednisone group and the mitoxantrone group. Urology 2000; Gravis G, Boher JM, Joly F et al: Androgen deprivation therapy (ADT) plus docetaxel versus ADT alone in metastatic non castrate prostate cancer: impact of metastatic burden and long-term survival analysis of the randomized phase 3 GETUG-AFU15 trial. Palliative care itself is an interdisciplinary, holistic approach to managing an advanced disease such as prostate cancer with a guarded prognosis. N Engl J Med 2018; Fizazi K,Shore N,Tammela TL et al: Darolutamide in nonmetastatic, castration-resistant prostate cancer. (Conditional Recommendation; Evidence Level: Grade C). Finally, the landscape of evidence detailing the interactions between mutations and treatment individualization continues to evolve, and the use of genetic testing may ultimately enable the treating clinician to offer a personalized approach to prostate cancer treatment. PSMA PET imaging can identify sites of prostate cancer with superior specificity and sensitivity compared to conventional imaging.163-165 These findings are already impacting treatment planning by altering physician decision-making, but they have yet to demonstrate a clear benefit specific to patient outcomes.166 With recent expanded indications for PSMA PET imaging in newly diagnosed high-risk individuals, the impact and implications of additional findings remains to be determined. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription.90 In the double-blind, phase III TITAN study,91 525 patients were assigned to receive apalutamide (240mg daily) with ADT compared to 527 patients receiving placebo plus ADT. BJU Int 2012; AndrioleGL,Kostakoglu L,Chau A et al: the impact of positron emission tomography with 18f-fluciclovine on the treatment of biochemical recurrence of prostate cancer: results from the LOCATE trial. N Engl J Med 2019; Grasso CS, Wu Y-M, Robinson DR et al: The mutational landscape of lethal castration-resistant prostate cancer. Prostate Int. We also excluded in vitro and animal studies. As such, it is recommended that a baseline laboratory and imaging assessment be performed to inform discussions around prognosis and clinical decision-making. Clin Ca Res 2019; Smith MR, Lee WC, Brandman J et al: Gonadotropin-releasing hormone agonists and fracture risk; a claims-based cohort study of men with nonmetastatic prostate cancer. Expert highlights AUA guideline on prostate cancer screening and follow-up. The potential importance of germline and somatic tumor testing, covered in guideline statements 13 and 28, largely surrounds their promise for predicting responses to PARP inhibitors such as olaparib, rucaparib, niraparib, veliparib, and talozaparib. Patients diagnosed with aggressive cancer defined by DAmico risk factors (cT3a or greater, Grade Group 4/5, or PSA>20ng/mL) should undergo routine bone scan and cross-sectional imaging (CT or MRI) or PET imaging at the time of diagnosis. At the time of planned interim analysis, the median OS was 18.4 months in the enzalutamide group versus 13.6 months in the placebo group (HR for death in the enzalutamide group=0.63; 95% CI: 0.53 to 0.75; P<0.001). These terms are summarized in Table 1. Prostate cancer is the most commonly diagnosed solid organ malignancy in US men and remains the second leading cause of cancer deaths for this population. In the STAMPEDE trial, the most frequently reported adverse events in the SOC plus docetaxel group included febrile neutropenia (15%), general disorder (including lethargy, fever, asthenia7%), and gastrointestinal disorder (including diarrhea, abdominal pain, constipation, vomiting8%).6. The frequency of grade 3/4 events was similar between the treatment arms.98. Comparisons were against placebo, no therapy or another active intervention, and intermittent versus continuous therapy. Clinicians should not offer systemic chemotherapy or immunotherapy to nmCRPC patients outside the context of a clinical trial. June 29th 2023. Lancet Oncol 2019; Morris MJ, Rowe SP, Gorin MA et al: Diagnostic performance of. Clinicians should offer a PARP inhibitor to patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated mCRPC following prior treatment with enzalutamide or abiraterone acetate, and/or a taxane-based chemotherapy. J Urol. Clinicians should also be advised against concurrent use of abiraterone acetate plus prednisone in combination with radium-223 given the association with a higher risk of skeletal related events.131, Clinicians should offer 177Lu-PSMA-617 to patients with progressive mCRPC having previously received docetaxel and androgen pathway inhibitor with a positive PSMA PET imaging study. Faraday M, Hubbard H, Kosiak B et al: Staying at the cutting edge: a review and analysis of evidence reporting and grading; the recommendations of the American Urological Association. PSMA PET availability is increasing in the U.S. and detects metastatic disease at low PSA values. Deaths due to adverse events on trial irrespective of attribution occurred in 32 patients (3%) receiving enzalutamide and 3 patients (1%) receiving placebo. There may be clinical settings as in long-term response to the initial agent (abiraterone acetate/enzalutamide) or asymptomatic patients with disease progression in whom a therapeutic trial of the alternative agent is reasonable. This is also assuming that all forms of local therapy (e.g., salvage radiotherapy after radical prostatectomy, or salvage prostatectomy/salvage local ablative therapy after external beam radiotherapy [EBRT]) have been exhausted. 2004; Beland G, Elhilali M, Fradet Y et al: A controlled trial of castration with and without nilutamide in metastatic prostatic carcinoma. Guidelines in Oncology for Prostate Cancer Early Detection state the following:7 . Some patients might prefer a limited 18-week course of docetaxel to daily oral therapy for years. (Clinical Principle), 25. In most reported studies, PSA is a measured variable and recorded at several time points at diagnosis and during treatment (baseline, induction [after a defined period of therapy], serial monitoring, and at progression). Performance status and predicted life expectancy are both critical elements to incorporate into individualized clinical decision-making in men with advanced prostate cancer. Clinicians should assess if a newly diagnosed mHSPC patient is experiencing symptoms from metastatic disease at the time of presentation to guide discussions of prognosis and further disease management. The treatment of men with mCRPC has dramatically changed over the past decade. Median OS was not reached in either group. In CHAARTED,72 patients were prospectively defined as having low- or high-volume disease, with high-volume disease defined as presence of visceral metastases and/or greater than or equal to four bone metastases with at least one outside of the vertebral column and pelvis. There are also plans for a surgical treatment arm in the STAMPEDE study (NCT03678025). As the therapeutic landscape evolves to include increasingly complex combinations of systemic therapies with or without local therapies, advances in imaging, and germline and somatic genetic testing, treating men with advanced prostate cancer is increasingly one that must embrace multidisciplinary management approaches. J Clin Oncol 2013; Howard LE, Moreira DM, De Hoedt A et al: Thresholds for PSA doubling time in men with non-metastatic castration-resistant prostate cancer. Baseline bone mineral density measurement with dual x-ray absorptiometry (DXA) may be considered in men receiving androgen deprivation and other systemic treatments for prostate cancer.143,144 Several observational studies have assessed changes in bone mineral density.145-149 Many of these studies reveal that the largest decrease in bone mineral density occurs within the first year of therapy, although bone loss has been observed beyond one year of therapy. At the time of planned primary analysis, median MFS was 40.5 months in the apalutamide group compared to 16.2 months in the placebo group (HR=0.28; 95% CI: 0.23 to 0.35; P<0.001), representing a 72% reduction in the risk of distant metastasis or death. ADT should not be routinely initiated in this population (Expert Opinion). Unfortunately, the discriminative accuracy was only 67% to predict metastases and 69% to predict prostate cancer-related death. In addition to being increasingly common, mHSPC and treatment of this disease state has shifted greatly since the first studies (CHAARTED and STAMPEDE) testing up-front docetaxel were reported beginning in 2014.5,6 Metastatic hormone-sensitive disease can occur due to recurrence after initial local therapy for localized prostate cancer or as de novo metastatic disease, a distinction that may be useful when deciding upon systemic therapy. Lancet Oncol 2019; James ND, de Bono JS, Spears MR et al: Abiraterone for prostate cancer not previously treated with hormone therapy. These studies do not meet all the criteria for a rating of low risk of bias, but no flaw is likely to cause major bias. As such, clinicians should monitor liver enzymes as well as potassium levels. Cancer 1990; Denis LJ, Carnelro de Moura JL, Bono A et al: Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). Unfortunately, no comparative data on efficacy exist between the previously discussed options. As the majority of patients treated in both PEACE-1 and ARASENS had de novo metastatic disease, the role of dual intensification or triplet therapy in patients with mHSPC with progression following curative-intent local therapy remains undefined. (Expert Opinion). It is important to acknowledge that clinical trials have generally excluded patients with a poor performance status from participation. Additionally, median time to PSA progression was approximately 33 months longer in patients receiving enzalutamide compared to those receiving placebo (37.2 months in the enzalutamide group compared to 3.9 months in the placebo group; HR=0.07; P<0.001). The use of MFS rather than OS as a regulatory endpoint is novel in solid tumors, and was partially based on the Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) meta-analysis of 19 clinical trials demonstrating that MFS is a surrogate for OS in men with localized prostate cancer.12 Additionally, recent press releases state that two of the three approved AR antagonists also improve OS in this population.13,14 Data from the third study continues to mature. It was also found that consolidation of all PSMA-positive disease decreased the risk of new lesions at 6 months (16% versus 63%; P=0.006).59. Calais J, Ceci F, Eiber M et al: 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single arm, comparative imaging trial. In the STAMPEDE trial,89 1,917 patients were randomized in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1,000mg daily) and prednisolone (5mg daily). In a second study, SWOG 9916 tested docetaxel and estramustine versus mitoxantrone and prednisone for 12 cycles in 674 men with mCRPC.16 Patients in the docetaxel plus prednisone arm had improvements in median survival (17.5 versus 15.6 months, P=0.02) and time to progression (6.3 versus 3.2 months, p<0.001), and a 20% reduction in risk of death. 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Median overall survival in cohort A was 18.5 months with olaparib compared to 15.1 months in the control group. Furthermore, clinicians should consider known differences in biochemical response to treatment among different therapies for mCRPC when determining the interval between imaging studies. In newly diagnosed mHSPC patients, clinicians should assess the extent of metastatic disease (low- versus high-volume). The primary endpoints were OS and radiographic PFS. A low grade indicates low confidence that the evidence reflects the true effect and further research is likely to change the confidence in the estimate of effect and could increase the confidence in the estimate. Because prostate cancer often grows slowly, men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Early detection of prostate cancer: AUA guidelines. For older patients or those with multiple comorbidities, a formal geriatric or medical assessment may provide assistance for the clinician in making management recommendations. To date, there is a lack of prospective randomized data evaluating PET as a staging study for untreated prostate cancer, mHSPC or CRPC.167 What will ultimately determine the role of these PET agents will be trials demonstrating imaging improved patient outcomes as a direct result of earlier intensification of systemic therapies, MDT, and/or prediction of responses to specific therapies. stratified 1,199 men with CRPC after chemotherapy in a 2:1 ratio to receive enzalutamide (160mg per day) or placebo.17 The primary endpoint was OS. This is an appropriate treatment for patients with symptomatic bone pain and non-visceral metastases. The trial demonstrated non-inferiority of 12-week dosing intervals for prevention of SREs. 2010;60:70-98. Osteoporosis-related fractures were also reduced among patients treated with bisphosphonates (RR=0.80; 95% CI: 0.69 to 0.94; NNT to prevent one additional fracture: 167).