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AKEEGA®

(niraparib and abiraterone acetate)

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AKEEGA® (niraparib and abiraterone acetate)

Medical Information

AKEEGA - AMPLITUDE Study

Last Updated: 10/16/2025

SUMMARY  

  • AMPLITUDE (NCT04497844) is an ongoing, phase 3, randomized, double-blind, placebo-controlled, multicenter, global study evaluating the efficacy and safety of niraparib and abiraterone acetate (AA) with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC; N=696).1-5
    • The primary endpoint of radiographic progression-free survival (rPFS) in the AKEEGA with prednisone group vs placebo/abiraterone acetate plus prednisone (AAP) group was met:5 
      • BRCA subgroup: not estimable (NE) vs 26.0 months; HR, 0.52; 95% CI, 0.37-0.72; P<0.0001
      • HRR effector subgroup: NE vs 27.6 months; HR, 0.57; 95% CI, 0.42-0.77; P=0.0003
      • ITT population: NE vs 29.5 months; HR, 0.63; 95% CI, 0.49-0.80; P=0.0001
    • A summary of adverse events (AEs) is described in Table: Adverse Events. In the AKEEGA with prednisone vs placebo/AAP group, the most common AEs of interest were anemia (51.6% vs 23.9%) and hypertension (43.8% vs 32.5%), respectively.5 

CLINICAL DATA

AMPLITUDE Study

Attard et al (2025)5 reported efficacy and safety results of AKEEGA with prednisone plus ADT vs placebo/AAP plus ADT in patients with deleterious germline or somatic HRR gene-altered mCSPC (N=696).

Study Design/Methods

  • Phase 3, randomized, double-blind, placebo-controlled, multicenter, global study
  • The study design is presented in Figure: AMPLITUDE Study Design.
  • Key efficacy endpoint testing was conducted using a hierarchical graphical approach, first in the BRCA subgroup (BRCA1 or BRCA2 alterations), then HRR effector subgroup (ie, immediate effectors of HRR at DNA double-strand breaks [BRCA subgroup + BRIP1, PALB2, RAD51B, RAD54L]), and then all intention-to-treat (ITT) patients (HRR effectors subgroup + CDK12, CHEK2, and FANCA).

AMPLITUDE Study Design1-4,6

Abbreviations: AA, abiraterone acetate; AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; AML, acute myeloid leukemia; ARPI, androgen receptor pathway inhibitor; BRCA, breast cancer susceptibility gene; CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; HRR, homologous recombination repair; mCSPC, metastatic castration-sensitive prostate cancer; MDS, myelodysplastic syndrome; MRI, magnetic resonance imaging; NIRA, niraparib; PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor; PBO, placebo; PC, prostate cancer; QD, once daily; R, randomization; rPFS, radiographic progression-free survival.
aPatients with lymph node-only disease were not eligible. Metastatic disease as documented by CT, MRI, or bone scan.
bFinal dose must be received ≤3 months prior to randomization.
c≤1 course radiation or surgery for symptoms; radiation completed before randomization.
dIf completed ≥1 year before randomization.
eIncluding radiation, prostatectomy, lymph node dissection, and systemic therapies.
fBy investigator. Defined as time from randomization to date of radiographic progression or death, whichever occurred first.
gEvaluation based on adverse events and clinical lab evaluations using National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.

Results

Patient Characteristics

Table: Select Baseline Patient and Disease Characteristics4,5a 
AKEEGA + Prednisone Group
(n=191)
PBO/AAP Group
(n=196)
AKEEGA + Prednisone Group
(n=230)
PBO/AAP Group
(n=226)
AKEEGA + Prednisone Group
(N=348)
PBO/AAP Group
(N=348)
BRCA subgroup
HRR Effector subgroup
ITT population
Median age, years (range)
67
(41-88)
66
(44-92)
68
(41-88)
66
(40-92)
68
(40–88)
67
(40-92)
ECOG-PS score, n (%)
  0
133 (69.6)
130 (66.3)
162 (70.4)
147 (65.0)
242 (69.5)
218 (62.6)
  1
55 (28.8)
65 (33.2)
63 (27.4)
77 (34.1)
97 (27.9)
124 (35.6)
  2
3 (1.6)
1 (0.5)
5 (2.2)
2 (0.9)
9 (2.6)
6 (1.7)
Gleason score at initial diagnosis, n (%)
  ≤7
25 (13.1)
30 (15.3)
34 (14.8)
34 (15.0)
60 (17.2)
68 (19.5)
  >7
160 (83.8)
158 (80.6)
187 (81.3)
182 (80.5)
276 (79.3)
262 (75.3)
  Unknown
6 (3.1)
8 (4.1)
9 (3.9)
10 (4.4)
12 (3.4)
18 (5.2)
Metastatic stage at initial diagnosis, n (%)
  Non-
  metastatic
14 (7.3)
16 (8.2)
19 (8.3)
20 (8.8)
32 (9.2)
36 (10.3)
  Metastatic
167 (87.4)
175 (89.3)
200 (87.0)
201 (88.9)
301 (86.5)
302 (86.8)
  Unknown
10 (5.2)
5 (2.6)
11 (4.8)
5 (2.2)
15 (4.3)
10 (2.9)
Metastatic disease volume at start of ADT, n (%)
  High
151 (79.1)
155 (79.1)
179 (77.8)
178 (78.8)
269 (77.3)
271 (77.9)
  Low
40 (20.9)
41 (20.9)
51 (22.2)
48 (21.2)
79 (22.7)
77 (22.1)
Median time from start of ADT for metastatic disease, months (range)
2.14
(0.2-6.0)
2.32
(0.3-6.1)
2.27
(0.2-6.2)
2.30
(0.3-6.1)
2.46
(0.2-6.2)
2.30
(0.1-6.2)
Median PSA level at initial diagnosis, µg/L (range)
-
-
-
-
112.3
(0.1-17475)
101.6
(0.1-15900)
Median PSA level at baseline, µg/L (range)b
-
-
-
-
2.74
(0-8046)
3.57
(0-2703)
Prior prostatectomy or RT, n (%)
47 (24.6)
40 (20.4)
57 (24.8)
48 (21.2)
86 (24.8)c
81 (23.3)
Prior first-generation antiandrogen use, n (%)
99 (51.8)
97 (49.5)
117 (50.9)
114 (50.4)
169 (48.7)c
165 (47.4)
Prior docetaxel use, n (%)
29 (15.2)
33 (16.8)
33 (14.3)
36 (15.9)
54 (15.6)
56 (16.1)
Site of metastases,d n (%)
  Bone only
-
-
-
-
146 (42)
154 (44)c
  Visceral
-
-
-
-
57 (16)
54 (16)c
  Lymph nodes
-
-
-
-
173 (50)
161 (46)c
Single gene alterations, n (%)
  BRCA2
148 (77.5)
144 (73.5)
148 (64.3)
144 (63.7)
148 (42.5)
144 (41.4)
  CHEK2
-
-
-
-
72 (20.7)
76 (21.8)
  CDK12
-
-
-
-
28 (8.0)
28 (8.0)
  BRCA1
25 (13.1)
25 (12.8)
25 (10.9)
25 (11.1)
25 (7.2)
25 (7.2)
  FANCA
-
-
-
-
15 (4.3)
15 (4.3)
  RAD54L
-
-
12 (5.2)
6 (2.7)
12 (3.4)
6 (1.7)
  PALB2
-
-
9 (3.9)
13 (5.8)
9 (2.6)
13 (3.7)
  BRIP1
-
-
9 (3.9)
4 (1.8)
9 (2.6)
6 (1.7)
  RAD51B
-
-
4 (1.7)
5 (2.2)
4 (1.1)
5 (1.4)
Co-occurring BRCA alterationsd
18 (9.4)
27 (13.8)
18 (7.8)
27 (11.9)
18 (5.2)
27 (7.8)
  BRCA2/CHEK2
5 (2.6)
13 (6.6)
5 (2.2)
13 (5.8)
5 (1.4)
13 (3.7)
Co-occurring non-BRCA alterationse
-
-
5 (2.2)
2 (0.9)
8 (2.3)
5 (1.4)
Abbreviations: AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; ECOG-PS, Eastern Cooperative Oncology Group performance status; HRR, homologous recombination repair; ITT, intention-to-treat; mCSPC, metastatic castration-sensitive prostate cancer; PBO, placebo; PSA, prostate-specific antigen; RT, radiotherapy.
aPercentages may not total 100 because of rounding.bPatients were allowed to be on ongoing ADT; therefore, PSA levels were lower than at diagnosis.cn=347.dNon-mutually exclusive.
eAll other co-occurring BRCA and non-BRCA alterations occurred at a frequency of <1%.
Efficacy
  • A summary of study results is provided in Table: Primary, Secondary, and Other Endpoint Results. The median follow-up was 30.8 months (data cutoff: January 7, 2025).
  • Subgroup analyses by alteration type are summarized in Table: Subgroup Analysis by BRCA and non-BRCA Alterations.
  • The treatment effect of AKEEGA with prednisone vs placebo/AAP on median rPFS in the ITT population was generally consistent across several prespecified subgroups, including patients with high-volume disease at baseline (41.2 months [events/N, 100/269] vs 26.3 months [130/271]; HR, 0.65; 95% CI, 0.50-0.85) and M1 disease at diagnosis (NE [100/301] vs 27.4 months [142/302]; HR, 0.60; 95% CI, 0.47-0.78).
  • While not a prespecified analysis, there was a hazard ratio of 0.81 (95% CI, 0.56-1.18) for rPFS in patients without BRCA1/2 alterations.
  • Of the 196 patients in the placebo/AAP group that discontinued treatment, at data cutoff, 141 (72%) patients were reported to have received a life-prolonging subsequent treatment for prostate cancer chosen based on the treating physician’s judgement and local approvals. Subsequent therapies used are provided in Table: Subsequent Therapy (ITT Population).
  • Health-related quality of life (HRQoL) Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores from cycle 2 showed improvement from baseline in the placebo/AAP group but an initial decline at cycles 2-4 compared with baseline in the AKEEGA with prednisone group. HRQoL FACT-P scores improved in the AKEEGA with prednisone group by cycle 5 with no difference observed compared with the placebo/AAP group from cycles 5-37.

Table: Primary, Secondary, and Other Endpoint Results5 
AKEEGA + Prednisone Group
(n=191)
PBO/AAP Group
(n=196)
AKEEGA + Prednisone Group
(n=230)
PBO/AAP Group
(n=226)
AKEEGA + Prednisone Group
(N=348)
PBO/AAP Group
(N=348)
BRCA subgroup
HRR Effector subgroup
ITT population
Primary Endpoint
Median rPFS,a months
NE
26.0
NE
27.6
NE
29.5
Number of events
57
93
71
102
113
151
HR (95% CI)
0.52 (0.37-0.72)
0.57 (0.42-0.77)
0.63 (0.49-0.80)
P-Value
<0.0001
0.0003
0.0001
Secondary Endpoints
Median time to symptomatic progression,b months
NE
NE
NE
NE
NE
NE
HR (95% CI)
0.44 (0.29-0.68)
0.49 (0.33-0.74)
0.50 (0.36-0.69)
P-Value
0.0001
0.0004
<0.0001
Median OS,b,c months
NE
NE
NE
NE
NE
NE
HR (95% CI)
0.75 (0.51-1.11)
0.81 (0.57-1.16)
0.79 (0.59-10.4)
P-Value
0.15
0.25
0.10
Median time to subsequent therapy, months
44.6
30.0
44.6
33.6
44.6
NE
HR (95% CI)
0.47 (0.33-0.66)
0.50 (0.36-0.69)
0.54 (0.41-0.70)
P-Value
Nominal P<0.0001*
Nominal P<0.0001*
Nominal P<0.0001*
Other Endpoints
Median second progression-free survival, months
NE
44.0
NE
44.0
NE
44.0
HR (95% CI)
0.59 (0.41-0.83)
0.63 (0.45-0.87)
0.66 (0.51-0.86)
P-Value
Nominal P=0.0026*
Nominal P=0.0049*
Nominal P=0.0017*
Objective response,e n/N (%)
48/63
(76.2)
53/72
(73.6)
58/76
(76.3)
58/79 (73.4)
76/106 (71.7)
81/110 (73.6)
HR (95% CI)d
1.04(0.85-1.26)
1.04(0.87-1.25)
0.97(0.83-1.15)
P-Value
0.73
0.68
0.75
Median time to PSA progression, months
NE
25.5
NE
29.0
NE
29.0
HR (95% CI)
0.41 (0.29-0.59)
0.48 (0.35-0.66)
0.50 (0.39-0.65)
P-Value
Nominal P<0.0001*
Nominal P<0.0001*
Nominal P<0.0001*
Confirmed PSA response,f %
88.5
85.7
87.0
85.8
87.6
86.2
HR (95% CI)d
1.03(0.96-1.12)
1.01 (0.94-1.09)
1.02(0.96-1.08)
P-Value
0.42
0.73
0.57
Abbreviations: AAP, abiraterone acetate plus prednisone; HRR, homologous recombination repair; HR, hazard ratio; ITT, intention-to-treat; NE, non estimable; OS, overall survival; PBO, placebo; PSA, prostate-specific antigen; rPFS, radiographic progression-free survival.
aBy investigator review. The results by blinded independent central review were similar: BRCA subgroup, HR, 0.51 (95% CI, 0.37-0.72), P<0.0001; HRR effector subgroup, HR, 0.58 (95% CI, 0.43-0.80), P=0.0006; and ITT population, HR, 0.61 (95% CI, 0.47-0.79), P=0.0001. This is the first and final analysis.
bFirst interim analysis; included in graphical approach for testing key efficacy endpoints.
cConducted when 193 patients died (n=85 in AKEEGA with prednisone group and n=108 in PBO/AAP group), which is ~50% of total needed events. First non-significant test in hierarchical graphical approach for testing key efficacy endpoints. P values provided for completeness.
dValue is relative risk.
eIn the ITT population, the duration of response in patients with complete or partial response was longer in the AKEEGA with prednisone group (HR, 0.55; 95% CI, 0.35-0.86; nominal P=0.008)*.
fDefined as ≥50% decrease from baseline.
*These endpoints were not adjusted for multiple comparisons. Therefore, the P-values displayed are nominal, and statistical significance has not been established.

Table: Subgroup Analysis by BRCA and non-BRCA Alterations4 
Endpoints
HR (95% CI)
Events/N
AKEEGA + Prednisone
Group
PBO/AAP Group
Primary Endpoint
Median rPFS, months
   BRCA1/2
0.52 (0.37-0.72)
57/191
93/196
   CHEK2
0.65 (0.38-1.11)
24/72
32/76
   CDK12
1.01 (0.43-2.39)
13/28
10/28
   FANCA
0.76 (0.20-2.82)
4/15
5/15
   PALB2
2.41 (0.66-8.74)
6/9
4/13
   Othera
0.72 (0.20-2.66)
6/25
4/15
Secondary Endpoints
Median time to symptomatic progression, months
   BRCA1/2
0.44 (0.29-0.68)
31/191
66/196
   CHEK2
0.47 (0.21-1.05)
9/72
18/76
   CDK12
0.68 (0.28-1.62)
9/28
12/28
   FANCA
0.71 (0.12-4.27)
2/15
3/15
   PALB2
NE (NE-NE)
1/9
2/13
   Othera
1.18 (0.12-11.36)
4/25
1/15
Median OS, months
   BRCA1/2
0.75 (0.51-1.11)
44/191
61/196
   CHEK2
0.85 (0.45-1.59)
18/72
21/76
   CDK12
0.57 (0.25-1.31)
9/28
15/28
   FANCA
0.92 (0.20-4.12)
3/15
4/15
   PALB2
3.30 (0.52-21.21)
3/9
2/13
   Othera
0.79 (0.18-3.36)
5/25
3/15
Abbreviations: AAP, abiraterone acetate plus prednisone; HR, hazard ratio; NE, non estimable; OS, overall survival; PBO, placebo; rPFS, radiographic progression-free survival.
Note: Non-BRCA subgroups were not statistically powered for formal testing in this exploratory analysis. Hazard ratios were stratified by disease volume (high vs low).
aRAD54L, BRIP1, RAD51B.

Table: Subsequent Therapy (ITT Population)4,5a
Patients who discontinued treatment intervention, n (%)
AKEEGA + Prednisone
(n=159)b
PBO/AAP
(n=196)
Any subsequent prostate cancer therapy (denominator for below)
89
141
Chemotherapyc
71 (79.8)
102 (72.3)
ARPId
27 (30.3)
40 (28.4)
PARPie
10 (11.2)
47 (33.3)
Radiopharmaceuticals
8 (9.0)
10 (7.1)
Immunotherapy
2 (2.2)
7 (5.0)
Otherf
7 (7.9)
15 (10.6)
Abbreviations: AAP, abiraterone acetate plus prednisone; ARPI, androgen receptor pathway inhibitor; ITT, intention-to-treat; PARPi, PARP inhibitor; PBO, placebo; rPFS, radiographic progression-free survival.
aData reflects all subsequent lines of therapy. Recurrent medications were counted only once per patient. Selected subsequent therapies were those with potential rPFS benefit.bOne randomized patient never received the study treatment.
cMost common in AKEEGA + prednisone vs PBO/AAP were as follows, respectively: docetaxel (n=59 [83.1%] vs n=84 [82.4%]), cabazitaxel (n=18 [25.4%] vs n=27 [26.5%]), and carboplatin (n=11 [15.5%] vs n=15 [14.7%]).
dMost common in AKEEGA + prednisone vs PBO/AAP were as follows, respectively: enzalutamide (n=23 [85.2%] vs n=36 [90.0%]) and apalutamide (n=3 [11.1%] vs n=3 [7.5%]).
eMost common in AKEEGA + prednisone vs PBO/AAP was: olaparib (n=10 [100%] vs n=42 [89.4%]), respectively.
fCapivasertib, ODM 208, AMG 509, vobramitamab duocarmazine, ZEN 3694, cabozantinib, datopotamab deruxtecan, enfortumab vedotin, investigational antineoplastic drugs, NUV 868, zanzalintinib.
Safety
  • A summary of AEs reported in both treatment arms that occurred from the time of first dose of the trial intervention through 30 days after the last dose is shown in Table: Adverse Events. Other common AEs of any grade included constipation (35.2% vs 16.4%), nausea (30.8% vs 14.4%), fatigue (26.2% vs 18.4%), arthralgia (21.0% vs 21.3%), back pain (19.6% vs 22.1%), COVID-19 (18.7% vs 20.4%), hot flush (18.2% vs 13.8%), leukopenia (16.7% vs 5.2%), vomiting (16.1% vs 8.6%), peripheral edema (15.9% vs 12.1%), weight decreased (15.3% vs 5.2%), and alanine aminotransferase increased (6.3% vs 15.5%) in the AKEEGA with prednisone vs placebo/AAP groups, respectively.

Table: Adverse Events4-6 
AE, n (%)
AKEEGA + Prednisone Groupa
(n=347)c
PBO/AAP Groupb
(n=348)
Any Grade
Grade 3-4
Any Grade
Grade 3-4
Any AE
346 (99.7)
261 (75.2)
341 (98.0)
205 (58.9)
Serious AEs
136 (39.2)
-
96 (27.6)
-
AEs leading to treatment discontinuationd
51 (14.7)e
-
36 (10.3)
-
TEAEs leading to dose reduction
76 (21.9)
-
24 (6.9)
-
TEAEs leading to dose interruption
232 (66.9)
-
147 (42.4)
-
AEs leading to death
14 (4.0)f
-
7 (2.0)
-
TEAEs of interestg
Patients with ≥1 AE of interest
306 (88)
217 (63)
261 (75)
132 (38)
Hematologic
   Anemiah
179 (51.6)
101 (29.1)
83 (23.9)
16 (4.6)
   Neutropenia
76 (21.9)
33 (9.5)
28 (8.0)
7 (2.0)
   Thrombocytopenia
66 (19.0)
24 (6.9)
20 (5.7)
1 (0.3)
   MDS
1 (<1)
1 (<1)
0
0
Cardiovascular
   Hypertension
152 (43.8)
92 (26.5)
113 (32.5)
64 (18.4)
   Arrhythmia
68 (20)
19 (5)
28 (8)
11 (3)
   Cardiac failure
20 (6)
9 (3)
6 (2)
4 (1)
Others
   Hypokalemia
90 (25.9)
40 (11.5)
70 (20.1)
38 (10.9)
   Hepatotoxicity
46 (13)
8 (2)
71 (20)
19 (5)
Abbreviations: AAP, abiraterone acetate plus prednisone; AE, adverse event; COVID-19, coronavirus 2019; MDS, myelodysplastic syndrome; NIRA, niraparib; PBO, placebo; TEAE, treatment-emergent adverse event.
aMedian treatment duration: 25.3 months.
bMedian treatment duration: 22.5 months.
cOne randomized patient never received study drug.
dAn AE was counted as leading to discontinuation of study treatment if it led to withdrawal of NIRA/PBO or AA/PBO or prednisone. The most common in AKEEGA + prednisone vs PBO/AAP were as follows, respectively: anemia (n=8 [2.3%] vs n=2 [0.6%]), asthenia (n=4 [1.2%] vs n=3 [0.9%]), sudden death (n=3 [0.9%] vs n=1 [0.3%]), alanine aminotransferase increased (n=1 [0.3%] vs n=5 [1.4%]), aspartate aminotransferase increased (n=1 [0.3%] vs n=4 [1.1%]), hypokalemia (0 vs n=3 [0.9%]), and spinal cord compression (0 vs n=3 [0.9%]).
eIncluded one case of MDS in a patient with a CHEK2 germline mutation.
fIncluded 4 cases of respiratory infection, including 2 attributed as related to COVID-19, 4 attributed to cardiac causes, 3 classified as sudden death, and 1 each of sepsis, subdural hematoma, and multiorgan dysfunction syndrome.
gPatients were counted only once for any given event, regardless of the number of times they actually experienced the event. The event experienced by the patient with the worst toxicity grade was used. If a patient had missing toxicity for a specific AE, the patient was only counted in the total column for the AE. hRequired ≥1 transfusion in the AKEEGA + prednisone vs PBO/AAP groups, respectively: 87 (25.1%) with median of 2 (range: 1-5) vs 13 (3.7%) with median of 2 (range: 1-3).

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 08 October 2025.

 

References

Show
1 Rathkopf DE, Chi KN, Olmos D, et al. AMPLITUDE: a study of niraparib in combination with abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombinant repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). Rapid abstract presentation presented at: American Society of Clinical Oncology Genitourinary (ASCO) Genitourinary Cancers Symposium; February 11-13, 2021; Virtual.  
2 Janssen Research & Development, LLC. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for the treatment of participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC) (AMPLITUDE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 June 11]. Available from: https://clinicaltrials.gov/show/NCT04497844 NLM Identifier: NCT04497844.  
3 Rathkopf DE, Chi KN, Olmos D, et al. AMPLITUDE: niraparib and abiraterone acetate plus prednisone to treat patients with metastatic castration-sensitive prostate cancer and deleterious germline or somatic homologous recombination repair gene alterations. Poster presented at: 23rd Annual Meeting of the Society of Urologic Oncology (SUO); November 30-December 2, 2022; San Diego, CA.  
4 Attard G, Agarwal N, Graff JN, et al. Phase 3 AMPLITUDE trial: niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. Oral Presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL.  
5 Attard G, Agarwal N, Graff JN, et al. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial [published online ahead of print]. Nat. Med. 2025. doi:10.1038/s41591-025-03961-8.  
6 Attard G, Aggarwal N, Graff JN, et al. Supplement for: Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial [published online ahead of print]. Nat. Med. doi:10.1038/s41591-025-03961-8.