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ERLEADA® (apalutamide)

Medical Information

ERLEADA - PRESTO Study

Last Updated: 10/30/2025

SUMMARY

  • PRESTO (AFT-19; NCT03009981) is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the efficacy and safety of ERLEADA plus androgen deprivation therapy (ADT), ERLEADA plus abiraterone acetate plus prednisone (AAP) plus ADT, and ADT in patients with high-risk biochemically relapsed (BCR) prostate cancer following prior radical prostatectomy (RP) without metastases on conventional imaging and a prostate-specific antigen (PSA) doubling time (PSADT) of ≤9 months (N=503). The primary endpoint was PSA progression-free survival (PSA-PFS).1,2
    • In the first interim analysis, with a median follow-up of 21.5 months, PSA-PFS was significantly prolonged for the ERLEADA + ADT vs ADT arm (median, 24.9 months vs 20.3 months; HR, 0.52; 95% CI, 0.35-0.77; P=0.00047). PSA-PFS was also significantly longer at a median follow-up of 21.3 months for the ERLEADA + AAP + ADT vs ADT arm (median, 26.0 months vs 20.0 months; HR, 0.48; 95% CI, 0.32-0.71; P=0.00008).1
    • In an updated analysis, at a median time from randomization to last contact of 26.5 months (ERLEADA + ADT vs ADT) and 26.8 months (ERLEADA + AAP + ADT vs ADT), the ERLEADA + ADT arm (HR, 0.59; 97.5% CI, 0.40-0.85; 1-sided P=0.0006) and the ERLEADA + AAP + ADT arm (HR, 0.53; 97.5% CI, 0.36-0.77; 1-sided P=0.00006) prolonged biochemical progression-free survival (bPFS) compared with the ADT arm.3
    • In the final analysis, with a median follow-up of 61 months, metastasis-free survival (MFS) was prolonged for the ERLEADA + ADT vs ADT arm, as assessed by 48-month restricted mean survival time (RMST; difference, 2.92 months; 95% CI, 0.45-5.39). For the ERLEADA + ADT and ERLEADA + AAP + ADT arms vs the ADT arm, respectively, the HR for time to castration resistance (TTCR) was 0.58 (95% CI, 0.36-0.95) and 0.55 (95% CI, 0.34-0.90), HR for time to subsequent treatment (TTST) was 0.75 (95% CI, 0.56-1.00) and 0.64 (95% CI, 0.47-0.86), and HR for PSA-PFS in the testosterone-recovered subset was 0.71 (95% CI, 0.55-0.93) and 0.61 (95% CI, 0.47-0.80).4 
    • In an analysis evaluating health-related quality of life (HRQoL) outcomes, no statistically significant mean changes from baseline to end of treatment (EOT) were observed between the ERLEADA + ADT or ERLEADA + AAP + ADT vs ADT treatment arms in any HRQoL measure.5
    • Any-grade treatment-emergent adverse events (TEAEs) were reported in 145 (91%), 148 (91%), and 155 (96%) patients treated with ADT, ERLEADA + ADT, and ERLEADA + AAP + ADT, respectively. There were no treatment-related deaths. The most frequently reported grade ≥3 adverse event (AE) was hypertension in all arms (Table: Most Common TEAEs of Clinical Interest).1
    • Post hoc analyses evaluating the sensitivity of PSA-PFS, association of baseline factors with PSA-PFS, time to testosterone recovery (TTTR) after treatment completion, PSA-PFS in the strata of <3 months or 3-9 months PSADT at study entry, and association between PSA nadir within the first 3 months of treatment with subsequent PSA-PFS have been conducted.1,6,7

Guidelines

  • In the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer, the following treatment options are noted in PROS-12:8
    • In the treatment for progressive M0 castration-sensitive prostate cancer (CSPC) after maximal pelvic therapy, apalutamide plus ADT is an option useful in certain circumstances: patients with biochemical recurrence after RP who meet the following high-risk criteria: PSADT <9 months; PSA >0.5 ng/mL; and prior adjuvant or secondary radiation therapy (RT) or not considered a candidate for RT (category 2B).*
  • Please refer to the NCCN Guidelines® for Prostate Cancer at www.nccn.org for current and complete recommendations for the use of apalutamide in prostate cancer.8
  • Please refer to the full Prescribing Information for ERLEADA (apalutamide) for information on INDICATIONS AND USAGE.9

*Aggarwal R, et al. J Clin Oncol 2024;42:1114-1123.

CLINICAL DATA

Aggarwal et al (2024)1 evaluated the efficacy and safety of ERLEADA plus ADT, ERLEADA plus AAP plus ADT, and ADT alone in patients with high-risk BRPC following prior RP without metastases on conventional imaging and a PSADT of ≤9 months (N=503).

Study Design/Methods

PRESTO Study Design1,2,4,10

Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; AE, adverse event; BID, twice daily; BRPC, biochemically relapsed prostate cancer; MFS, metastasis-free survival; PFS, progression-free survival; PO, orally; PSA, prostate-specific antigen; PSADT, prostate-specific antigen doubling time; QD, once daily; QoL, quality of life; RP, radical prostatectomy; TTCR, time to castration resistance; TTST, time to subsequent treatment; TTTR, time to testosterone recovery.

aPrior ADT and/or first-generation antiandrogen (eg, bicalutamide, nilutamide, flutamide) in the neoadjuvant and/or salvage setting before, during, and/or following radiation or surgery was permitted provided the last effective dose was >9 months prior to randomization and total duration was ≤36 months.

bLuteinizing hormone-releasing hormone analog (degarelix or leuprolide with bicalutamide) per investigator discretion.

cDefined as time from the date of randomization to PSA progression or death. During the treatment period, PSA progression was defined as a rise of ≥25% and 2 ng/mL above nadir, confirmed by repeat measurement. During follow-up, PSA progression was defined as the first date by which PSA levels >0.2 ng/mL were recorded and confirmed on repeat measurement ≥2 weeks later.

dAssessed using Cox proportional hazards (preplanned) and 48-month restricted mean survival time due to observed violation of the proportional hazards assumption, based on conventional or metabolic imaging.

eDefined as the subset of patients who recovered serum testosterone to >50 ng/dL during follow-up.

fAt the time of PSA progression, patients were followed long term with treatment administered per the investigator’s discretion.

Results

Baseline Characteristics

Select Baseline Characteristics1
ADT
(n=166)
ERLEADA + ADT
(n=168)
ERLEADA + AAP + ADT
(n=169)
Overall Study Cohort
(N=503)
Median (Q1-Q3) age, years
67 (60.3-71.1)
66 (60.7-70.3)
67.3 (62.4-71.3)
66.7 (61.1-71)
Gleason grade at diagnosis n (%)
   6-7
101 (60.8)
101 (60.1)
105 (62.1)
307 (61)
   8
17 (10.2)
21 (12.5)
18 (10.7)
56 (11.1)
   9-10
48 (28.9)
43 (25.6)
43 (25.4)
134 (26.6)
Missing
0 (0)
3 (1.8)
3 (1.8)
6 (1.2)
Median (Q1-Q3) serum PSA at study entry, ng/mL
1.7 (1-3.2)
1.8 (1-3.6)
1.8 (0.9-4.2)
1.8 (1-3.6)
PSADT strata, months, n (%)
   <3
43 (25.9)
43 (25.6)
44 (26)
130 (25.8)
   3-9
123 (74.1)
125 (74.4)
125 (74)
373 (74.2)
Median (Q1-Q3) time interval from RP to study entry, years
4.6 (2.8-7.3)
4.7 (2.8-6.5)
4 (2.8-6.8)
4.4 (2.8-6.8)
Previous radiation, n (%)
147 (88.6)
142 (84.5)
137 (81.1)
426 (84.7)
Previous ADT
71 (42.8)
75 (44.6)
67 (39.6)
213 (42.3)
Median (Q1-Q3) serum testosterone at study entry, ng/dL
351.5
(269-452)
378
(274-460)
338.5
(271-472.5)
354.5
(272-461.3)
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; PSA, prostate-specific antigen; PSADT, prostate-specific antigen doubling time; Q, quarter; RP, radical prostatectomy.
Efficacy
  • There were 383 (76%) patients that completed the 52-week treatment period, and 63 (13%) patients remain on study treatment.
    • Reasons for discontinuation included: withdrawal in 27 (5%) patients, PSA progression in 10 (2%) patients, AE in 8 (2%) patients, and other reasons in 12 (2%) patients.
  • In the first interim analysis1:
    • In the ERLEADA + ADT arm, PSA-PFS was significantly prolonged compared with the ADT arm (median, 24.9 months vs 20.3 months; HR, 0.52; 95% CI, 0.35-0.77; P=0.00047), after a median follow-up of 21.5 months and 102 PSA-PFS events.
    • In the ERLEADA + AAP + ADT arm, PSA-PFS was significantly prolonged compared with the ADT arm (median, 26.0 months vs 20.0 months; HR, 0.48; 95% CI, 0.32-0.71; P=0.00008) after a median follow-up of 21.3 months.
    • In the analysis of ERLEADA + ADT vs ADT, 152 patients recovered serum testosterone to >50 ng/dL after treatment completion. In this subgroup, the addition of ERLEADA to ADT significantly prolonged PSA-PFS compared with ADT alone (HR, 0.53; 95% CI, 0.34-0.82).
    • In the analysis of ERLEADA + AAP + ADT vs ADT, 149 patients recovered serum testosterone to >50 ng/dL after treatment completion. In this subgroup, the addition of ERLEADA + AAP to ADT prolonged PSA-PFS compared with ADT alone (HR, 0.60; 95% CI, 0.39-0.92).
  • In an updated analysis3:
    • The median time from randomization to last contact for the analyses of ERLEADA + ADT vs ADT and ERLEADA + AAP + ADT vs ADT was 26.5 months and 26.8 months, respectively.
    • There were 146 bPFS events in the ERLEADA + ADT vs ADT arm and 142 events in the ERLEADA + AAP + ADT vs ADT arm.
    • In the ERLEADA + ADT arm, bPFS was significantly prolonged compared with to the ADT arm (HR, 0.59; 97.5% CI, 0.40-0.85; 1-sided P=0.0006).
    • In the ERLEADA + AAP + ADT arm, bPFS was significantly prolonged compared with the ADT arm (HR, 0.53; 97.5% CI, 0.36-0.77; 1-sided P=0.00006).
    • The median TTTR for the ADT, ERLEADA + ADT, and ERLEADA + AAP + ADT arms was 3.9, 3.8, and 4.7 months, respectively.
  • In the final analysis4:
    • The HR for MFS was 0.80 (95% CI, 0.56-1.13) for the ERLEADA + ADT vs ADT arm and 0.92 (95% CI, 0.66-1.28) for the ERLEADA + AAP + ADT vs ADT arm, after a median follow-up of 61 months and 197 (39%) MFS events. MFS was prolonged for the ERLEADA + ADT vs ADT arm, as assessed by 48-month RMST analysis (difference, 2.92 months; 95% CI, 0.45-5.39).
    • The HR for TTCR was 0.58 (95% CI, 0.36-0.95) for the ERLEADA + ADT vs ADT arm and 0.55 (95% CI, 0.34-0.90) for the ERLEADA + AAP + ADT vs ADT arm.
    • The HR for TTST was 0.75 (95% CI, 0.56-1.00) for the ERLEADA + ADT vs ADT arm and 0.64 (95% CI, 0.47-0.86) for the ERLEADA + AAP + ADT vs ADT arm.
    • In the testosterone-recovered subset, the HR for PSA-PFS was 0.71 (95% CI, 0.55-0.93) for the ERLEADA + ADT vs ADT arm and 0.61 (95% CI, 0.47-0.80) for the ERLEADA + AAP + ADT vs ADT arm.
  • There was no significant difference in TTTR after treatment completion, accounting for competing risks of death or metastatic disease, in the ERLEADA + ADT or ERLEADA + AAP + ADT arms compared with the ADT arm.
HRQoL Outcomes
  • Mean changes in HRQoL from baseline to EOT were evaluated across the 3 treatment arms (Table: Mean Changes in HRQoL From Baseline to EOT).5
  • For each measure, the mean differences between the ADT arm and the ERLEADA + ADT or ERLEADA + AAP + ADT arms were not statistically significant. Additionally, the numerical differences for each HRQoL measure between treatment arms did not meet the published minimally clinically important difference thresholds.

Mean Changes in HRQoL From Baseline to EOT5
Mean Changesa
ADT
ERLEADA + ADT
ERLEADA + AAP + ADT
ERLEADA + ADT vs ADT
P-Value
ERLEADA + AAP + ADT vs ADT
P-Value
HFRDIS
14.3
14.3
15.0
>0.99
0.78
EPIC-26 Sexual domain
-15.3
-15.8
-16.0
0.87
0.82
PROMIS Fatigue Short Form
5.3
6.9
7.0
0.09
0.08
EQ-5D-5L Index
-0.01
-0.02
-0.01
0.77
0.55
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; EOT, end of treatment; EPIC, Expanded Prostate Cancer Index Composite; EQ-5D-5L, 5-level version of the European Quality of Life-5 Dimensions; HFRDIS, Hot Flash Related Daily Interference Scale; HRQoL, health-related quality of life; PROMIS, Patient Reported Outcome Measurement Information System.
aBetween-arm mean differences in HRQoL were estimated using general linear mixed modeling in an intent-to-treat approach.
Safety

Most Common TEAEs of Clinical Interest1
AEs, n (%)
ADT
(n=160)
ERLEADA + ADT
(n=163)
ERLEADA + AAP + ADT
(n=161)
Grade 1
Grade 2
Grade 3
Grade 4
Grade 1
Grade 2
Grade 3
Grade 4
Grade 1
Grade 2
Grade 3
Grade 4
Any-grade TEAEs, n (%)
145 (91)
148 (91)
155 (96)
Dose interruptions and/or reductions, n (%)
13 (8)
32 (20)
73 (45)
Treatment discontinuation due to an AE, n (%)a
0 (0)
3 (2)
5 (3)
Serious AEs, n (%)
13 (8)
14 (9)
28 (17)
   Hypertension
9 (5.6)
19 (11.9)
12 (7.5)
0 (0)
11 (6.7)
25 (15.3)
12 (7.4)
0 (0)
12 (7.5)
18 (11.2)
29 (18)
2 (1.2)
   Hot flashes
102 (63.8)
19 (11.9)
1 (0.6)
0 (0)
116 (71.2)
8 (4.9)
0 (0)
0 (0)
110 (68.3)
23 (14.3)
0 (0)
0 (0)
   Fatigue
67 (41.9)
14 (8.8)
0 (0)
0 (0)
77 (47.2)
8 (4.9)
3 (1.8)
0 (0)
78 (48.4)
16 (9.9)
2 (1.2)
0 (0)
   Injection site reaction
49 (30.6)
9 (5.6)
0 (0)
0 (0)
47 (28.8)
10 (6.1)
0 (0)
0 (0)
36 (22.4)
11 (6.8)
0 (0)
0 (0)
   Insomnia
21 (13.1)
9 (5.6)
0 (0)
0 (0)
29 (17.8)
5 (3.1)
0 (0)
0 (0)
30 (18.6)
8 (5)
0 (0)
0 (0)
   Hyperglycemia
11 (6.9)
0 (0)
3 (1.9)
0 (0)
13 (8)
6 (3.7)
2 (1.2)
0 (0)
24 (14.9)
6 (3.7)
5 (3.1)
0 (0)
   Rash
6 (3.8)
2 (1.3)
1 (0.6)
0 (0)
24 (14.7)
7 (4.3)
3 (1.8)
0 (0)
19 (11.8)
3 (1.9)
5 (3.1)
0 (0)
   Erectile dysfunction
1 (0.6)
10 (6.3)
1 (0.6)
0 (0)
2 (1.2)
6 (3.7)
1 (0.6)
0 (0)
4 (2.5)
2 (1.2)
0 (0)
0 (0)
   Arthralgia
26 (16.3)
4 (2.5)
1 (0.6)
0 (0)
17 (10.4)
2 (1.2)
0 (0)
0 (0)
21 (13)
2 (1.2)
0 (0)
0 (0)
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; AE, adverse event; TEAE, treatment-emergent adverse event.
aAn additional 3 (2%) patients receiving ERLEADA + ADT and 3 (2%) patients receiving ERLEADA + AAP + ADT discontinued oral study agent(s) but continued ADT alone because of an AE.
  • In an updated analysis3:
    • Hypertension was the most common grade ≥2 AE in the ADT (19%), ERLEADA + ADT (23%), and ERLEADA + AAP + ADT (30%) arms.
    • Treatment discontinuations occurred in 3 (2.1%) and 5 (3.4%) patients in the ERLEADA + ADT and ERLEADA + AAP + ADT arms, respectively.
Post Hoc Analyses

Analyses of PSA-PFS


PSA-PFS Sensitivity Analysis1
ERLEADA + ADT
ERLEADA + AAP + ADT
Median follow-up, months
26.4
26.8
PSA-PFS events
44 additional events in the ERLEADA + ADT vs ADT arm
40 additional events in the ERLEADA + AAP + ADT vs ADT arm
HR (95% CI)
0.59 (0.42-0.81)
0.53 (0.38-0.74)
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; CI, confidence interval; HR, hazard ratio; PSA-PFS, prostate-specific antigen-progression-free survival.

PSA-PFS by PSADT at Study Entry1
PSADT <3 Months
PSADT 3-9 Months
Overall
ERLEADA + ADT vs ADT
ERLEADA + AAP + ADT vs ADT
ERLEADA + ADT vs ADT
ERLEADA + AAP + ADT vs ADT
ERLEADA + ADT vs ADT
ERLEADA + AAP + ADT vs ADT
PSA-PFS events, n/N
13/39 vs 17/38
13/41 vs 17/40
32/106 vs 40/105
30/108 vs 42/109
45/145 vs 57/143
43/149 vs 59/149
HR (95% CI)
0.57
(0.28-1.18)
0.46
(0.22-0.95)
0.50
(0.31-0.80)
0.48
(0.30-0.77)
0.50
(0.34-0.75)
0.47
(0.32-0.70)
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; CI, confidence interval; HR, hazard ratio; PSADT, prostate-specific antigen doubling time; PSA-PFS, prostate-specific antigen-progression-free survival.

Association of Baseline Gleason Grade With PSA-PFS1,6
Gleason Grade
Median PSA-PFS, Months
Association With PSA-PFS
HR (95% CI) or P-Value
Grade 5 vs 4
-
Grade 5 was associated with a shorter PSA-PFS vs grade 4
0.59 (0.35-1.00)
Grade 5 vs ≤3
-
Grade 5 was associated with a shorter PSA-PFS vs grade ≤3
0.71 (0.53-0.96)
Grade ≥9 vs 8 vs 6-7
-
Grade ≥9 was associated with a shorter PSA-PFS vs grade 8 and grade 6-7
Log-rank P=0.0409
   Grade ≥9
21.9
   Grade 8
31.1
   Grade 6-7
25.2
Abbreviations: CI, confidence interval; HR, hazard ratio; PSA-PFS, prostate-specific antigen-progression-free survival.

Testosterone Recovery


Post Hoc Analysis of TTTR1
ADT
ERLEADA + ADT
ERLEADA + AAP + ADT
Recovery to >150 ng/dL
   Median TTTR, months
5.1
5.7
6.9
   HR (95% CI) for treatment
   vs ADT arm
-
0.88 (0.62-1.24)
0.66 (0.46-0.94)
Recovery to >280 ng/dL
   Median TTTR, months
9.0
9.1
11.1
   HR (95% CI) for treatment
   vs ADT arm
-
1.02 (0.65-1.58)
0.73 (0.47-1.15)
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; CI, confidence interval; HR, hazard ratio; PSA-PFS, prostate-specific antigen-progression-free survival.

PSA

  • A post hoc analysis evaluated the association between PSA nadir within the first 3 months of treatment with subsequent PSA-PFS among 463 evaluable patients across the 3 treatment arms (Table: Association Between PSA Nadir and PSA-PFS).7

Association Between PSA Nadir and PSA-PFS7
ADT
ERLEADA + ADT
ERLEADA + AAP + ADT
HR (95% CI); P-Value
Patients who achieved PSA nadir, %
   PSA <0.1 ng/mL
86.3
-
   PSA 0.1-0.2 ng/mL
4.4
-
   PSA ≥2 ng/mL
9.3
-
   PSA <0.2 ng/mL within 3 months of treatment initiation
79.8
96.9
95.0
-
Median time to PSA nadir, months (IQR)
2 (1.12-4.76)
-
   Association between time to PSA nadir and subsequent PSA-PFS
‑0.30 (standard error=0.03a)
-
Median PSA-PFS for patients who failed to reach PSA <0.2 ng/mL within 3 months of treatment initiation, months
13.9
5.60
(3.58-8.75); P<0.0001
Median PSA-PFS for patients with PSA ≤0.1 ng/mL, months
22.8
Median PSA-PFS for patients with 3-month PSA nadir 0.1-0.2 ng/mL, months
17.4
2.63
(1.49-4.63); P=0.0008
Median PSA-PFS for patients with 3-month PSA nadir ≤0.1 ng/mL, months
22.8
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; CI, confidence interval; HR, hazard ratio; IQR, interquartile range; PSA, prostate-specific antigen; PSA-PFS, prostate-specific antigen-progression-free survival.
aKendall’s tau modified for bivariate censoring.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 21 October 2025.

References

Show
1 Aggarwal R, Heller G, Hillman DW, et al. PRESTO: A phase III, open-label study of intensification of androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer (AFT-19). J Clin Oncol. 2024;42(10):1114-1123.  
2 Alliance Foundation Trials, LLC. A study of androgen annihilation in high-risk biochemically relapsed prostate cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 October 21]. Available from: https://clinicaltrials.gov/show/NCT03009981 NLM Identifier: NCT03009981.  
3 Aggarwal R, Eggener S, Heller G, et al. Updated progression-free survival from PRESTO: a phase 3 randomized study of androgen annihilation for high-risk biochemically relapsed prostate cancer (AFT-19) [abstract]. J Urol. 2023;209(Suppl. 4). Abstract LBA02-11.  
4 Aggarwal R, Hillman DW, Xiao H, et al. Final results from PRESTO: a phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). Abstract presented at: European Society for Medical Oncology (ESMO) Congress; October 17-21, 2025; Berlin, Germany.  
5 Chen RC, Mazza GL, Fruth B, et al. Health-related quality of life (HRQOL) results from PRESTO (AFT-19), a phase 3 randomized trial of intensification of androgen blockade in patients with high-risk biochemically relapsed castration sensitive prostate cancer [abstract]. J Clin Oncol. 2024;42(Suppl. 16). Abstract 5006.  
6 Aggarwal R, Heller G, Hillman D, et al. Baseline characteristics associated with PSA progression-free survival in patients (pts) with high-risk biochemically relapsed prostate cancer: results from the phase 3 PRESTO study (AFT-19) [abstract]. J Clin Oncol. 2023;41(Suppl. 6). Abstract 208.  
7 Aggarwal R, Dooley K, Hillman D, et al. Depth of PSA nadir and subsequent PSA progression-free survival in patients (pts) with high-risk biochemically relapsed prostate cancer: results from the phase 3 PRESTO study (AFT-19) [abstract]. J Clin Oncol. 2023;41(Suppl. 16). Abstract 5077.  
8 Referenced with permission from the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Prostate Cancer V.1.2025. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed December 12, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.  
9 ERLEADA (apalutamide) [Prescribing Information]. Horsham, PA: Janssen Products, LP; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ERLEADA-pi.pdf
10 Aggarwal RR, Eggener SE, Chen RC, et al. Protocol to: A phase 3 study of androgen annihilation in high-risk biochemically relapsed prostate cancer: An Alliance Foundation trial (AFT-19). J Clin Oncol. 2018;36 (15):5090.