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===== Darolutamide ===== * '''See [[Hormonal Therapy|Hormonal Therapy Chapter Notes]]''' ====== <span style="color:#ff00ff">ARAMIS ====== * Population: 1509 men with nonmetastatic, CRPC and a PSA doubling time ≤10 months * Randomized to darolutamide (600 mg [two 300-mg tablets] twice daily) vs. placebo * Primary outcome: metastasis free survival * Results: ** Metastasis-free survival improved by 22 months in the darolutamide arm (40 darolutamide vs. 18 months placebo) ** Overall survival significantly improved by 6% at 3 years in the darolutamide arm (83% darolutamide vs. 77% placebo) ** Darolutamide was also associated with benefits with regard to all secondary end points, including overall survival, time to pain progression, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event. * [https://www.ncbi.nlm.nih.gov/pubmed/30763142 Fizazi, Karim, et al."Darolutamide in nonmetastatic, castration-resistant prostate cancer." New England Journal of Medicine 380.13 (2019): 1235-1246.] * [https://pubmed.ncbi.nlm.nih.gov/32905676/ Fizazi, Karim, et al."Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide." ''New England Journal of Medicine'' 383.11 (2020): 1040-1049.] '''Detection of metastases and imaging in untreated patients§''' * '''Recommended screening for patients who progress on ADT without evidence of distant metastases:''' ** '''Modalities:''' *** '''Bone scans''' for bone metastases *** '''Imaging of the chest/abdomen/pelvis''' to monitor for lymph node and visceral metastases/progression **** Imaging techniques most commonly used include abdominal/pelvic CT and chest X-ray. **** The role of positron-emission tomography (PET) such as PSMA-PET are still unclear and the benefits unknown ** '''Frequency of imaging''' *** '''PSADT <10 months or PSA >20: every 3–6 months''' **** At high risk for developing metastases earlier *** '''PSADT > 10 months: every 6–12 months''' ** If metastases are detected, patients should be treated based on metastatic CRPC recommendations.
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