Actively Recruiting
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-05-08
1260
Participants Needed
186
Research Sites
700 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.
CONDITIONS
Official Title
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Evidence of metastatic disease based on conventional CT/MRI and/or bone scan
- No metachronous low-volume disease (no recurrent metastatic disease with \u2264 4 bone metastases and no visceral metastasis)
- Next generation sequencing results available from tissue based Clinical Laboratory Improvement Act test
- Prior androgen deprivation therapy (ADT) with or without anti-androgens within 120 days allowed
- No prior chemotherapy for prostate cancer
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Absolute neutrophil count (ANC) \u2265 1,500/mm3
- Hemoglobin \u2265 9.0 g/dL
- Platelet count \u2265 100,000/mm3
- Total bilirubin \u2264 1 x upper limit of normal (ULN), or with Gilbert's syndrome direct bilirubin \u2264 1 x ULN if total bilirubin > 1.5 x ULN
- AST/ALT \u2264 1.5 x ULN
- Calculated creatinine clearance > 30 mL/min
- Serum potassium \u2265 3.5 mmol/L
- Patients with prior or concurrent malignancies that do not interfere with study
- Patients with treated leptomeningeal metastases without progression
- Patients with controlled HIV infection on effective therapy
- Patients with undetectable hepatitis B viral load on therapy
- Patients cured of hepatitis C or with undetectable viral load on treatment
- No seizure or conditions predisposing to seizures
- Cardiac function New York Heart Association class II or better
- Stable asymptomatic deep venous thromboembolism on anticoagulation
- No uncontrolled hypertension (BP < 160/100 mmHg)
You will not qualify if you...
- Regional lymph node metastases only (below aortic bifurcation)
- Evidence of metastatic disease only by PSMA-PET not visible on CT, bone scan, or MRI
- Known hypersensitivity to study drugs or their formulations
- Chronic use of strong CYP3A4 inhibitors or inducers without discontinuation prior to study
- Use of medications that lower seizure threshold without substitution or discontinuation
- Any condition that would preclude study participation in investigator's opinion
- Uncontrolled hypertension (resting systolic BP \u2265 160 mmHg or diastolic BP \u2265 100 mmHg despite treatment)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 186 locations
1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
3
Kaiser Permanente Dublin
Dublin, California, United States, 94568
Actively Recruiting
4
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Actively Recruiting
5
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States, 93720
Actively Recruiting
6
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
7
Kaiser Permanente- Modesto MOB II
Modesto, California, United States, 95356
Actively Recruiting
8
Kaiser Permanente-Modesto
Modesto, California, United States, 95356
Actively Recruiting
9
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
10
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Actively Recruiting
11
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Actively Recruiting
12
Kaiser Permanente Downtown Commons
Sacramento, California, United States, 95814
Actively Recruiting
13
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Actively Recruiting
14
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Actively Recruiting
15
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
16
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Actively Recruiting
17
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Actively Recruiting
18
Kaiser San Rafael-Gallinas
San Rafael, California, United States, 94903
Actively Recruiting
19
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Actively Recruiting
20
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Actively Recruiting
21
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Actively Recruiting
22
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Actively Recruiting
23
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
Actively Recruiting
24
Kaiser Permanente-Franklin
Denver, Colorado, United States, 80205
Actively Recruiting
25
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81501
Actively Recruiting
26
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States, 80026
Actively Recruiting
27
Bayhealth Hospital Kent Campus
Dover, Delaware, United States, 19901
Actively Recruiting
28
Bayhealth Hospital Sussex Campus
Milford, Delaware, United States, 19963
Actively Recruiting
29
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
30
Malcom Randall Veterans Administration Medical Center
Gainesville, Florida, United States, 32610
Actively Recruiting
31
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
Actively Recruiting
32
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
33
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
34
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States, 83619
Actively Recruiting
35
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States, 83642
Actively Recruiting
36
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
37
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
38
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
39
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Actively Recruiting
40
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Actively Recruiting
41
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Actively Recruiting
42
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Actively Recruiting
43
Rush MD Anderson Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
44
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
45
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
46
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Actively Recruiting
47
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Actively Recruiting
48
Illinois CancerCare-Dixon
Dixon, Illinois, United States, 61021
Actively Recruiting
49
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
50
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Actively Recruiting
51
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Actively Recruiting
52
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Actively Recruiting
53
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Actively Recruiting
54
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Actively Recruiting
55
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
56
Carle BroMenn Medical Center
Normal, Illinois, United States, 61761
Actively Recruiting
57
Carle Cancer Institute Normal
Normal, Illinois, United States, 61761
Actively Recruiting
58
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States, 62269
Actively Recruiting
59
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States, 62269
Actively Recruiting
60
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Actively Recruiting
61
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Actively Recruiting
62
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Actively Recruiting
63
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Actively Recruiting
64
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Actively Recruiting
65
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
66
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
67
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
68
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Actively Recruiting
69
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
70
Illinois CancerCare - Washington
Washington, Illinois, United States, 61571
Actively Recruiting
71
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
72
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
73
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Suspended
74
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
75
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
76
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
77
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Suspended
78
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Actively Recruiting
79
HaysMed
Hays, Kansas, United States, 67601
Actively Recruiting
80
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Actively Recruiting
81
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
82
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
83
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
84
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
85
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
86
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
87
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
88
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
89
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, United States, 49829
Actively Recruiting
90
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Actively Recruiting
91
Hurley Medical Center
Flint, Michigan, United States, 48503
Actively Recruiting
92
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States, 48912
Actively Recruiting
93
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
94
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
95
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
96
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
97
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
98
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
99
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
100
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
101
University Health Truman Medical Center
Kansas City, Missouri, United States, 64108
Actively Recruiting
102
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
103
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
104
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
105
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
106
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
107
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
108
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
109
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
110
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
111
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
112
Saint Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
Actively Recruiting
113
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
114
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
115
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
116
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
117
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, United States, 08002
Actively Recruiting
118
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
119
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
120
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, United States, 08080
Actively Recruiting
121
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
122
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
123
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
124
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
125
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
126
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
127
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
128
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
129
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
130
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Actively Recruiting
131
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
132
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
133
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
134
ProMedica Flower Hospital
Sylvania, Ohio, United States, 43560
Actively Recruiting
135
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
136
Saint Vincent Hospital
Erie, Pennsylvania, United States, 16544
Actively Recruiting
137
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States, 15025
Actively Recruiting
138
Forbes Hospital
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
139
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, United States, 15065
Actively Recruiting
140
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
141
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
142
Jefferson Methodist Hospital
Philadelphia, Pennsylvania, United States, 19148
Suspended
143
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
144
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
145
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
146
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
147
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
148
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Actively Recruiting
149
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Actively Recruiting
150
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Actively Recruiting
151
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Actively Recruiting
152
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
153
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
154
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
155
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
156
Saint George Regional Medical Center
St. George, Utah, United States, 84770
Actively Recruiting
157
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States, 05602
Actively Recruiting
158
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
159
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
160
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, United States, 22408
Actively Recruiting
161
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
162
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
163
VCU Health Tappahannock Hospital
Tappahannock, Virginia, United States, 22560
Actively Recruiting
164
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
Actively Recruiting
165
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States, 54911
Actively Recruiting
166
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, United States, 54915
Actively Recruiting
167
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, United States, 53045
Actively Recruiting
168
Ascension Calumet Hospital
Chilton, Wisconsin, United States, 53014
Actively Recruiting
169
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, United States, 53132
Actively Recruiting
170
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
171
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
172
William S Middleton VA Medical Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
173
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
174
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, United States, 53097
Actively Recruiting
175
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, United States, 53211
Actively Recruiting
176
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
177
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States, 53151
Actively Recruiting
178
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
179
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Actively Recruiting
180
Ascension Mercy Hospital
Oshkosh, Wisconsin, United States, 54904
Actively Recruiting
181
Ascension All Saints Hospital
Racine, Wisconsin, United States, 53405
Actively Recruiting
182
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
183
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
184
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Actively Recruiting
185
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, United States, 53226
Actively Recruiting
186
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States, 53095
Actively Recruiting
Research Team
S
Shiva Baghaie, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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