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Metastatic Hormone-Sensitive Prostate Cancer
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==== <span style="color:#ff0000">Abiraterone</span> ==== * '''<span style="color:#ff00ff">STAMPEDE (James et al. NEJM 2017)</span>''' ** Population: 1917 patients had prostate cancer that was newly diagnosed and metastatic, node-positive, or high-risk locally advanced prostate cancer (with at least two of following: a tumor stage of T3 or T4, a Gleason score of 8 to 10, and a PSA level β₯40 ng per milliliter) or disease that was previously treated with radical surgery or radiotherapy and was now relapsing with high-risk features (in men no longer receiving therapy, a PSA level >4 ng per milliliter with a doubling time of <6 months, a PSA level >20 ng per milliliter, nodal or metastatic relapse, or <12 months of total ADT with an interval of >12 months without treatment) ** '''Randomized to ADT +/- abiraterone + prednisone''' ** Results: *** Overall and failure-free survival significantly improved in abiraterone + ADT ** [https://pubmed.ncbi.nlm.nih.gov/28578639/ James, Nicholas D., et al.] "Abiraterone for prostate cancer not previously treated with hormone therapy." New England Journal of Medicine 377.4 (2017): 338-351. * <span style="color:#ff00ff">'''LATITUDE (Fizazi et al. 2017)'''</span> ** Population: 1199 patients with high-risk, metastatic, hormone-sensitive prostate cancer *** '''<span style="color:#ff0000">High-risk required 2/3 high-risk factors:</span>''' ***# '''<span style="color:#ff0000">Visceral metastasis</span>''' ***# '''<span style="color:#ff0000">β₯ 3 bone lesions</span>''' ***#* '''<span style="color:#ff0000">Recall, CHAARTED was β₯4 bone lesions with β₯ 1 beyond the vertebral bodies and pelvis</span>''' ***# '''<span style="color:#ff0000">Gleason score β₯ 8</span>''' ** '''Randomized to ADT +/- abiraterone + prednisone</span>''' ** Primary end points: OS and radiographic progression-free survival ** Results: *** Median follow-up: 30 months *** OS significantly improved in the abiraterone group (median not reached abiraterone vs. 34.7 months placebo) (HR 0.62) *** Median length of radiographic progression-free survival significantly longer in the abiraterone group (33.0 months vs. 14.8 months placebo, HR 0.47) ** [https://pubmed.ncbi.nlm.nih.gov/28578607/ Fizazi, Karim, et al.] "Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer." New England Journal of Medicine 377.4 (2017): 352-360.
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