Editing Castrate-Resistant Prostate Cancer (section)

===== Apalutamide =====
* '''See [[Hormonal Therapy|Hormonal Therapy Chapter Notes]]'''
*'''Particular attention should be paid to monitoring thyroid stimulating hormone (TSH) in individuals with known hypothyroidism given observed changes in thyroid function with apalutamide treatment'''

====== <span style="color:#ff00ff">SPARTAN ======
* Population: 1207 men with non-metastatic CRPC and PSA doubling time ≤10 months
* Randomized to apalutamide (240mg daily) or placebo
* Primary outcome: metastasis-free survival
* Results:
** Median follow-up: 52 months (2021 update)
** Metastasis-free survival significantly improved by 24 months in the apalutamide arm (40 months apalutamide vs. 16 months placebo (HR for metastasis or death, 0.28)
** Overall survival significantly improved by 14 months in the apalutamide arm (74 apalutamide vs. 60 months placebo, HR=0.78; 95% CI, 0.64 to 0.96; p=0.00002).
** Additionally, secondary endpoints including time to symptomatic progression (HR= 0.45, p<0.001) and time to metastasis (HR=0.27, p<0.001) were significantly longer in the apalutamide arm compared to placebo. Median progression-free survival was 40.5 months in the apalutamide group versus 14.7 months in the placebo group (HR=0.29; p<0.001).
** Overall, 10.6% of patients receiving apalutamide discontinued treatment due to adverse events compared to 7.0% of patients receiving placebo.
* [https://www.ncbi.nlm.nih.gov/pubmed/29420164 Smith, Matthew R., et al."Apalutamide treatment and metastasis-free survival in prostate cancer." New England Journal of Medicine 378.15 (2018): 1408-1418.]
* [https://pubmed.ncbi.nlm.nih.gov/32907777/ Smith, Matthew R., et al."Apalutamide and overall survival in prostate cancer." ''European urology'' 79.1 (2021): 150-158.]