(apalutamide)
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Last Updated: 02/14/2025
Smith et al (2018)1
PCWG2 Criteria for PSA Progression | |
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Decline from baseline | Record time from start of therapy to first PSA increase that is ≥25% and ≥2 ng/mL above nadir, and which is confirmed by a second value 3 or more weeks later (ie, a confirmed PSA rising trend) |
No decline from baseline | PSA progression ≥25% and ≥2 ng/mL after 12 weeks |
Abbreviations: PCWG2, Prostate Cancer Working Group 2; PSA, prostate-specific antigen. |
ERLEADA Group (n=806) | Placebo Group (n=401) | |
---|---|---|
Median PSA at study entry, ng/mL | 7.78 | 7.96 |
Median PSADT, months | 4.40 | 4.50 |
PSADT (n, %) | ||
≤6 months | 576 (71.5) | 284 (70.8) |
>6 months | 230 (28.5) | 117 (29.2) |
Abbreviations: PSA, prostate-specific antigen; PSADT, prostate-specific antigen doubling time. |
Exploratory Endpoints | ERLEADA Group (n=806) | Placebo Group (n=401) | Hazard Ratio (95% CI) | P-Value |
---|---|---|---|---|
Median time to PSA progression, months | NR | 3.71 | 0.064 (0.052-0.080) | 0.0001 |
Patients with a PSA response (%) | 90 | 2 | 40.09 (20.99-76.58)a | 0.0001 |
Abbreviations: CI, confidence interval; NR, not reached; PSA, prostate-specific antigen. aThe comparison for this exploratory endpoint was calculated as a relative risk rather than as a hazard ratio. |
ERLEADA Group (n=806) | Placebo Group (n=401) | |
---|---|---|
PSA at baseline, ng/mL, median (Q1-Q3) | 7.78 (3.8-17.0) | 7.96 (3.9-19.2) |
PSA nadir, ng/mL | n=799 | n=395 |
Median (Q1-Q3) | 0.38 (0.1-1.6) | 7.24 (3.5-17.6) |
Maximum change in PSA from baseline, %, median (Q1-Q3) | -94 (-98 to -81) | 15 (4.1-28) |
Time to PSA nadir, months, median (Q1-Q3) | 7.4 (4.5-11.9) | 1.0 (1.0-1.8) |
Time to achieve PSA response, months | ||
≥50% PSA reduction | n=724 | n=9 |
Median (Q1-Q3) | 1.0 (1.0-1.0) | 1.9 (1.8-9.2) |
≥90% PSA reduction | n=498 | n=0 |
Median (Q1-Q3) | 1.9 (1.0-3.1) | NA |
PSA ≤0.2 ng/mL | n=303 | n=0 |
Median (Q1-Q3) | 2.8 (1.9-4.6) | NA |
Patients with confirmed PSA response by 6 months, n (%)a | ||
≥50% PSA reduction | 723 (90)b | 6 (1.5) |
≥90% PSA reduction | 462 (57)b | 0 |
PSA ≤0.2 ng/mL | 258 (32)b | 0 |
Patients with confirmed PSA response at 6 months, n (%)c | n=680 | n=107 |
≥50% PSA reduction | 648 (95) | 4 (3.7) |
≥90% PSA reduction | 428 (63) | 0 |
PSA ≤0.2 ng/mL | 233 (34) | 0 |
Abbreviations: NA, not applicable; PSA, prostate-specific antigen; Q, quartile. aBest PSA response during any time in the first 6 months of initiation of ERLEADA treatment. bP<0.001 for apalutamide vs placebo from the chi-squared test. cPSA response in patients who were alive at 6 months following initiation of treatment ± 28 days (1 ERLEADA treatment cycle). |
GC High Risk (n=76) | GC Low Risk (n=78) | Basal (n=102) | Luminal (n=52) | |
---|---|---|---|---|
Median PSA at baseline, ng/mL (Q1-Q3) | 6.8 (4.0-17.3) | 8.0 (3.9-13.5) | 7.0 (3.7-13.3) | 8.2 (4.8-16.8) |
Median PSA nadir, ng/mL, (Q1Q3) | 0.4 (0.1-1.7) | 0.2 (0.1-0.9) | 0.4 (0.1-1.8) | 0.2 (0.03-0.8) |
Median maximum change in PSA from baseline, % (Q1-Q3) | -93 (-99 to -80) | -97 (-99 to -87) | -92 (-98 to -79) | 98 (-99 to -93) |
Median time to PSA nadir, months, (Q1-Q3) | 7.3 (4.6-9.2) | 8.3 (4.6-12.9) | 7.3 (4.6-10.2) | 8.3 (5.6-11.1) |
≥50% PSA reduction, n (%) | ||||
Overall | 71 (93) | 73 (94) | 94 (92) | 50 (96) |
≤6 months | 71 (93) | 73 (94) | 94 (92) | 50 (96) |
Abbreviations: GC, genomic classifier; PSA, prostate-specific antigen; Q, quartile. |
Time to PSA Progression HR (95% CI; P-Value) | MFS HR (95% CI; P-Value) | OS HR (95% CI; P-Value) | |
---|---|---|---|
Achieved vs not achieved PSA response at 6 monthsb | |||
≥50% PSA reduction | 0.21 (0.13-0.35; <0.001c) | 0.46 (0.22-0.94; 0.03c) | 0.5 (0.3-0.84; 0.008c) |
≥90% PSA reduction | 0.25 (0.18-0.33; <0.001c) | 0.41 (0.29-0.57; <0.001c) | 0.45 (0.35-0.59; 0.001c) |
PSA ≤0.2 ng/mL | 0.13 (0.08-0.21; <0.001c) | 0.3 (0.19-0.47; <0.001c) | 0.26 (0.18-0.38; 0.001c) |
Deep PSA decline vs PSA decline <50% at 6 monthsd | |||
50 to <90% | 0.45 (0.27-0.75; 0.002c) | 0.78 (0.37-1.63; 0.50c) | 0.81 (0.47-1.37; 0.43c) |
≥90% | 0.12 (0.07-0.21; <0.001c) | 0.32 (0.15-0.68; 0.003c) | 0.37 (0.22-0.63; 0.001c) |
Abbreviations: CI, confidence interval; HR, hazard ratio; MFS, metastasis-free survival; OS, overall survival; PSA, prostate-specific antigen. aPSA response achieved in patients who were alive at 6 months following the initiation of ERLEADA ± 28 days (1 treatment cycle). bEach row has results from an individual Cox proportional-hazards model. cThe endpoints were not adjusted for multiple comparisons. Therefore, the P-value displayed is nominal, and statistical significance has not been established. dResults from 1 model considering depth of PSA response as a category. |
Additional information regarding the SPARTAN study, including the clinical study report, protocol, and statistical analysis plan, can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_toc.cfm (scroll to the “Sponsor Clinical Study Reports ARN-509-003 SPARTAN NCT # 01946204” section at the bottom of the web page).
Chi et al (2019)6
Adjusted 4-Year OS, % (95% CI) | ERLEADA Group (n=523) | Placebo Group (n=526) |
---|---|---|
PSA nadir achieved | 78 (74-83) | 66 (56-75) |
PSA nadir not achieved | 47 (40-54) | 46 (41-52) |
Abbreviations: CI, confidence interval; OS, overall survival; PSA, prostate-specific antigen. |
TITAN Study (N=1052) | SPARTAN Studya (N=1207) | |||||
---|---|---|---|---|---|---|
Age Group, Years | <65 (n=331) | 65-79 (n=628) | ≥80 (n=93) | <65 (n=149) | 65-79 (n=741) | ≥80 (n=317) |
Median (range) PSA nadir,b ng/mL | ||||||
ERLEADA group | 0.04 (0-133) n=148 | 0.02 (0-498) n=321 | 0.04 (0-83.7) n=52 | 0.20 (0-48.9) n=106 | 0.32 (0-32.2) n=488 | 0.75 (0-150) n=205 |
Placebo group | 0.93 (0-408) n=181 | 0.68 (0-1408) n=303 | 0.73 (0-1180) n=41 | 7.11 (1.5-67.2) n=43 | 7.18 (0.3-146) n=246 | 9.0 (1.0-292) n=106 |
Median time (range) to PSA nadir,b months | ||||||
ERLEADA group | 5.6 (0.1-40.6) n=149 | 5.6 (0.1-47.9) n=324 | 6.4 (1.0-36.8) n=52 | 8.7 (0.9-29.5) n=106 | 7.4 (0.9-44.2) n=488 | 6.5 (0.7-29.4) n=205 |
Placebo group | 2.8 (0.7-50.6) n=182 | 4.7 (0.8-50.0) n=304 | 3.7 (0.7-40.4) n=41 | 1.0 (0.9-35.7) n=43 | 1.0 (0.2-24.4) n=246 | 1.0 (0.8-8.3) n=106 |
Confirmed PSA decline ≥50% from baseline,c n (%) | ||||||
ERLEADA group | 132 (89) n=149 | 292 (90) n=324 | 49 (94) n=52 | 98 (93) n=106 | 451 (92) n=492 | 175 (84) n=208 |
Placebo group | 86 (47) n=182 | 180 (59) n=304 | 24 (59) n=41 | 1 (2.3) n=43 | 5 (2.0) n=249 | 3 (2.8) n=109 |
Median time (range) to confirmed PSA decline ≥50% from baseline,c,d | ||||||
ERLEADA group | 0.95 (0.9-8.3) n=149 | 0.95 (0.3-11.1) n=324 | 0.95 (0.9-9.2) n=52 | 0.95 (0.7-5.2) n=106 | 0.95 (0.5-10.2) n=492 | 0.95 (0.3-6.5) n=208 |
Placebo group | 0.97 (0.1-30.7) n=182 | 0.99 (0.1-35.4) n=304 | 1.4 (0.9-23.5) n=41 | 20.3 (20.3-20.3) n=43 | 1.9 (1.0-11.2) n=249 | 1.9 (1.8-4.6) n=109 |
Confimed PSA decline to ≤0.2 ng/mL,c n (%) | ||||||
ERLEADA group | 90 (60) n=149 | 231 (71) n=324 | 35 (67) n=52 | 51 (48) n=106 | 197 (40) n=492 | 55 (26) n=208 |
Placebo group | 52 (29) n=182 | 101 (33) n=304 | 13 (32) n=41 | 0 | 0 | 0 |
Median time (range) to confirmed PSA decline of ≤0.2 ng/mL,c,e | ||||||
ERLEADA group | 1.9 (0.9-29.4) n=149 | 1.9 (0.1-33.2) n=324 | 1.9 (0.9-25.8) n=52 | 2.8 (0.9-14.9) n=106 | 2.8 (0.9-25.8) n=492 | 2.8 (0.3-22.1) n=208 |
Placebo group | 1.0 (0.8-39.6) n=182 | 2.8 (0.7-42.0) n=304 | 4.7 (0.9-33.1) n=41 | NA n=0 | NA n=0 | NA n=0 |
Abbreviations: NA, not available due to lack of response; PSA, prostate-specific antigen. aOlder patients in the SPARTAN study population had higher median PSA levels than younger patients. bPatients with available PSA data are included. cConfirmed by a subsequent measurement ≥4 weeks later. dAssessed in patients with achieved ≥50% PSA decline from baseline. e |
HRQoL Measures | PSA Decline (≤0.2 ng/mL) | PSA Decline (≥90%) | ||
---|---|---|---|---|
3 Months | 6 Months | 3 Months | 6 Months | |
HR (95% CI); Events/N | ||||
SPARTAN Study | ||||
Median time to worsening in FACT-P total scorea | 33.2 months 0.83 (0.62-1.10); 64/119 | NR 0.80 (0.57-1.11); 55/127 | 29.7 months 0.84 (0.66-1.07); 142/264 | 44.2 months 1.01 (0.72-1.41); 113/238 |
Median time to worsening in FACT-P physical wellbeing subscale scoreb | 55.2 months 0.70 (0.51-0.94); 55/119 | NR 0.60 (0.42-0.84); 50/137 | 51.6 months 0.67 (0.52-0.86); 122/259 | 55.2 months 0.72 (0.52-0.99); 99/245 |
TITAN Study | ||||
Median time to worsening in FACT-P total scorea | 44.2 months 0.54 (0.38-0.76); 54/127 | NR 0.65 (0.42-1.01); 49/121 | 27.6 months 0.99 (0.69-1.41); 78/150 | 44.2 months 0.82 (0.51-1.30); 58/135 |
Median time to worsening in FACT-P physical wellbeing subscale scoreb | 29.5 months 0.63 (0.45-0.89); 65/128 | 42.3 months 0.66 (0.43-1.03); 48/112 | 20.3 months 0.82 (0.58-1.15); 82/148 | 40.8 months 0.60 (0.38-0.96); 56/127 |
Median time to BPI-SF worst pain intensity progressionc | NR 0.70 (0.49-1.00); 58/169 | NR 0.53 (0.34-0.81); 44/173 | NR 0.67 (0.47-0.95); 70/205 | NR 0.59 (0.38-0.94); 55/203 |
Median time to BFI worst fatigue intensity progressiond | NR 0.76 (0.53-1.10); 56/212 | NR 0.97 (0.63-1.49); 59/224 | NR 0.88 (0.61-1.29); 69/243 | NR 0.98 (0.61-1.56); 67/257 |
Abbreviations: BFI, Brief Fatigue Inventory; BPI-SF, Brief Pain Inventory-Short Form; CI, confidence interval; FACT-P, Functional Assessment of Cancer Therapy-Prostate; HR, hazard ratio; HRQoL, health-related quality of life; NR, not reached; PSA, prostate-specific antigen. aFACT-P total, ≥10 points. bPhysical wellbeing, ≥3 points. cBPI-SF worst pain, ≥30% increases. dBFI worst fatigue, ≥2 points. |
1 | Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418. |
2 | Smith MR, Saad F, Chowdhury S, et al. Protocol for: Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418. |
3 | Smith MR, Saad F, Chowdhury S, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79(1):150-158. |
4 | Small E, Lee J, Lopez-Gitlitz A, et al. Prostate-specific antigen (PSA) outcomes in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide (APA): results from phase 3 SPARTAN study [abstract]. J Urol. 2018;199(4):e232. Abstract PD10-11. |
5 | Saad F, Small EJ, Feng FY, et al. Deep prostate-specific antigen response following addition of apalutamide to ongoing androgen deprivation therapy and long-term clinical benefit in SPARTAN. Eur Urol. 2022;81(2):184-192. |
6 | Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381(1):13-24. |
7 | Chi KN, Agarwal N, Bjartell A, et al. Protocol for: Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381(1):13-24. |
8 | Chi KN, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study. J Clin Oncol. 2021;39(20):2294-2303. |
9 | Roy S, Malone S, Sun Y, et al. Differential treatment effect on overall survival (OS) based on early prostate specific antigen (PSA) response in metastatic hormone-sensitive prostate cancer (mHSPC): a secondary analysis of TITAN trial [abstract]. J Clin Oncol. 2024;42(4):Abstract 126. |
10 | Roy S, Sun Y, Chi KN, et al. Early prostate-specific antigen response by 6 months is predictive of treatment effect in metastatic hormone sensitive prostate cancer: an exploratory analysis of the TITAN trial. J Urol. 2024;212(5):672-681. |
11 | Chowdhury S, Bjartell A, Agarwal N, et al. Deep, rapid, and durable prostate-specific antigen decline with apalutamide plus androgen deprivation therapy is associated with longer survival and improved clinical outcomes in TITAN patients with metastatic castration-sensitive prostate cancer. Ann Oncol. 2023;34(5):477-485. |
12 | Chi KN, Chowdhury S, Bjartell A, et al. Supplement for: Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study. J Clin Oncol. 2021;39(20):2294-2303. |
13 | Small EJ, Chi KN, Chowdhury S, et al. Post hoc analysis of rapid and deep prostate-specific antigen decline and patient-reported health-related quality of life in SPARTAN and TITAN patients with advanced prostate cancer. Eur Urol Oncol. 2024;7(4):844-852. |
14 | Shen J, Chowdhury S, Agarwal N, et al. Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from phase 3 randomised clinical studies TITAN and SPARTAN. Br J Cancer. 2024;130(1):73-81. |
15 | Chaudhary R, Bhaumik A, Agarwal N, et al. Radiographic progression without PSA progression (R-PD) in advanced prostate cancer patients. Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; February 13-15, 2025; San Francisco, CA. |
16 | Chi K, Saad F, Chowdhury S, et al. Prostate-specific antigen kinetics in patients with advanced prostate cancer treated with apalutamide: results from the TITAN and SPARTAN studies. Poster presented at: American Society of Clinical Oncology (ASCO) Scientific Program; May 29-31, 2020; Virtual. |
17 | Chi K, Saad F, Chowdhury S, et al. Prostate-specific antigen kinetics in patients with advanced prostate cancer treated with apalutamide: results from the TITAN and SPARTAN studies. Oral presentation presented at: American Urological Association (AUA) Annual Meeting; September 10-13, 2021; Virtual. |
18 | Ye DW, Uemura H, Chung BH, et al. Prostate-specific antigen kinetics in Asian patients with metastatic castration-sensitive prostate cancer treated with apalutamide in the TITAN trial: a post hoc analysis. Int J Urol. 2024;32(2):164-172. |
19 | Graff J, Saad F, Hadaschik B, et al. Metastasis-free survival in nonmetastatic castration-resistant prostate cancer patients with prostate-specific antigen decline to < 0.2 ng/mL following apalutamide treatment: post hoc results from the phase 3 SPARTAN study. Poster presented at: American Urological Association (AUA) Annual Meeting; May 3-6, 2019; Chicago, IL. |
20 | Saad F, Graff J, Hadaschik B, et al. Molecular determinants of prostate-specific antigen kinetics and clinical response to apalutamide in patients with nonmetastatic castration-resistant prostate cancer in SPARTAN. Poster presented at: American Society of Clinical Oncology (ASCO) Scientific Program; May 29-31, 2020; Virtual. |
21 | Merseburger AS, Agarwal N, Bhaumik A, et al. Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: a subgroup analysis of the randomised clinical TITAN study. Eur J Cancer. 2023;193:113290. |
22 | Merseburger A, Agarwal N, Bhaumik A, et al. Supplement for: Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: a subgroup analysis of the randomised clinical TITAN study. Eur J Cancer. 2023;193:113290. |
23 | Fukuokaya W, Yanagisawa T, Mori K, et al. Radiographic progression without corresponding prostate-specific antigen progression in patients with metastatic castration-sensitive prostate cancer receiving apalutamide: secondary analysis of the TITAN trial. [Published online ahead of print April 29, 2024]. Eur Urol Oncol. doi:10.1016/j.euo.2024.04.009 |
24 | Merseburger AS, Agarwal N, Bjartell A, et al. Targeted investigational treatment analysis of novel anti-androgen (TITAN) study: ultralow prostate-specific antigen decline with apalutamide plus androgen-deprivation therapy. BJU Int. 2024;134(6):982-991. |
25 | Lowentritt B, Brown G, Pilon D, et al. Real-world prostate-specific antigen response and treatment adherence of apalutamide in patients with non-metastatic castration-resistant prostate cancer. Urology. 2022;166:182-188. |
26 | Lowentritt B, Brown G, Kernen K, et al. Real-world effectiveness and treatment adherence of apalutamide in non-metastatic castration-resistant prostate cancer patients. Oral presentation presented at: American Urological Association (AUA) Annual Meeting; September 10-13, 2021; Virtual. |
27 | Lowentritt B, Du S, Rossi C, et al. Real-world prostate-specific antigen response and disease progression among patients with non-metastatic castration-resistant prostate cancer initiated on apalutamide. Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; February 16-18, 2023; San Francisco, CA. |
28 | Hegele A, Häußermann R, Schultheis S, et al. Apalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC): real world data of a multicenter study. J Cancer Res Clin Oncol. 2024;150(9):414. |
29 | Maughan BL, Liu Y, Mundle S, et al. Rapid and deep prostate-specific antigen (PSA) response to apalutamide plus ADT correlates with improved survival in metastatic castration-sensitive prostate cancer (mCSPC) in real world practice in the US (OASIS project). Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL. |
30 | Wenzel M, Cano Garcia C, Humke C, et al. Prostate-specific antigen nadir and cancer-control outcomes in real-world apalutamide-treated metastatic hormone-sensitive prostate cancer patients: a single-center analysis. [Published online ahead of print August 31, 2024]. Eur Urol Oncol. doi:10.1016/j.euo.2024.08.007. |
31 | Brown G, Du S, Khilfeh I, et al. Prostate-specific antigen response in Black patients with metastatic castration-sensitive prostate cancer treated with apalutamide versus abiraterone acetate – a real-world comparison. Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; February 13-15, 2025; San Francisco, CA. |
32 | Bivins V, Durkin M, Khilfeh I, et al. Early prostate-specific antigen response among Black and non-Black patients with advanced prostate cancer treated with apalutamide. Future Oncol. 2022;18(32):3595-3607. |
33 | Lowentritt B, Du S, Rossi C, et al. Real-world treatment response and persistence among Black and non-Black patients with metastatic castration-sensitive prostate cancer treated with apalutamide in a urology setting. Poster presented at: International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting; May 7-10, 2023; Boston, MA. |
34 | Pilon D, Durkin M, Rossi C, et al. Depth of prostate-specific antigen response among patients with metastatic castration-sensitive prostate cancer treated with apalutamide, enzalutamide, or abiraterone acetate in a community urology setting. Poster presented at: Academy of Managed Care Pharmacy (AMCP) Annual Nexus Meeting; October 18-21, 2021; Denver, CO. |
35 | Lowentritt B, Pilon D, Khilfeh I, et al. Attainment of early, deep prostate-specific antigen response in metastatic castration-sensitive prostate cancer: a comparison of patients initiated on apalutamide or enzalutamide. Urol Oncol. 2023;41(5):253.e1-253.e9. |
36 | Lowentritt B, Pilon D, Waters D, et al. Comparison of prostate-specific antigen response in patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or abiraterone acetate: a retrospective cohort study. Urol Oncol. 2023;41(5):252.e19-252.e27. |
37 | Lowentritt B, Du S, Rossi C, et al. Prostate-specific antigen response and time-to-castration resistance among patients with metastatic castration sensitive prostate cancer initiated on apalutamide, enzalutamide, or abiraterone acetate. Poster presented at: 2023 American Urological Association (AUA) Annual Meeting; April 28-May 1, 2023; Chicago, IL. |
38 | Brown G, Khilfeh I, Du S, et al. Prostate-specific antigen response among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or abiraterone acetate in real-world urology practices (PROMPT-2). Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; January 25-27, 2024; San Francisco, CA. |
39 | Lowentritt BH, Du S, Pilon D, et al. Real-world comparison of prostate-specific antigen response in patients with metastatic castration-sensitive prostate cancer treated with apalutamide or enzalutamide (PROMPT-1). Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; January 25-27, 2024; San Francisco, CA. |
40 | Maughan BL, Liu Y, Mundle S, et al. Survival outcomes of APA as a starting treatment: impact in real-world patients with mCSPC (OASIS). Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; January 25-27, 2024; San Francisco, CA. |
41 | Brown GA, Du S, Khilfeh I, et al. Comparison of prostate-specific antigen (PSA) response in patients with de novo metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (APA) vs abiraterone acetate (ABI): a real-world (RW) causal analysis [abstract]. J Clin Oncol. 2024;42(Suppl. 16):Abstract e17070. |
42 | Lowentritt BH, Khilfeh I, Pilon D, et al. Real-world (RW) comparison of prostate-specific antigen (PSA) response in patients with de novo metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (APA) versus enzalutamide (ENZ) [abstract]. J Clin Oncol. 2024;42(suppl 16):Abstract e17067. |
43 | Smith MR, Saad F, Chowdhury S, et al. Supplement for: Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418. |
44 | Chi KN, Agarwal N, Bjartell A, et al. Supplement for: Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381(1):13-24. |
45 | Small EJ, Chi KN, Chowdhury S, et al. Supplement for: Post hoc analysis of rapid and deep prostate-specific antigen decline and patient-reported health-related quality of life in SPARTAN and TITAN patients with advanced prostate cancer. Eur Urol Oncol. 2024;7(4):844-852. |