Actively Recruiting
A Phase 3 Randomized, Open-label Study of Pasritamig With Docetaxel Versus Docetaxel for Metastatic Castration-Resistant Prostate Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
800
Participants Needed
136
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining pasritamig with docetaxel can extend the time without disease worsening as seen on scans, compared to docetaxel alone, in men with metastatic castrate-resistant prostate cancer (mCRPC). This cancer grows despite low male hormone levels, and the study focuses on improving radiographic progression-free survival. The trial is a phase 3, randomized, open-label study sponsored by Janssen Research & Development, LLC. Participants are randomly assigned to one of two groups: one receives pasritamig plus docetaxel until disease progression or study end, and the other receives docetaxel along with prednisone. Treatments continue until confirmed radiographic progression or other protocol criteria are met. The study compares these two approaches to assess their impact on disease progression and overall outcomes. During the study, participants will be monitored with scans and assessments to measure progression-free survival up to about 1 year and 10 months. Additional outcomes, including overall survival, symptom progression, response rates, prostate-specific antigen (PSA) levels, quality of life, and safety, will be tracked for up to approximately 4 years and 5 months. Researchers will evaluate adverse events, laboratory results, pain, and health-related quality of life using various questionnaires throughout the study.
CONDITIONS
Brief Title
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically confirmed adenocarcinoma of the prostate
- Have metastatic disease at the time of screening as determined by the investigator
- Are receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone analog or have had prior bilateral orchiectomy with serum testosterone less than or equal to 50 ng/dL at screening
- Have progressed on at least 1 novel androgen receptor pathway inhibition but no more than 2 different ARPI treatments and have discontinued ARPI before randomization
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You will not qualify if you...
- Known history of brain or leptomeningeal prostate cancer metastases
- Have known BRCA 1/2 mutations without prior treatment with a PARP inhibitor unless not available or contraindicated
- Prior or concurrent second malignancy that could interfere with study endpoints
- Have received cytotoxic chemotherapy for prostate cancer in any setting
- Have received prior treatment with human kallikrein 2 (KLK-2) directed therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year and 10 months
Participants receive pasritamig with docetaxel or docetaxel with prednisone as treatment for metastatic castration-resistant prostate cancer until confirmed radiographic progression or other protocol defined criteria are met.
Regular visits during treatment period
Duration - Up to approximately 4 years and 5 months
Participants are monitored for overall survival, disease progression, response, and quality of life after treatment ends.
Periodic visits up to 4 years and 5 months
Trial Site Locations
Total: 136 locations
1
Arizona Clinical Trials
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
MemorialCare Orange Coast Medical Center
Fountain Valley, California, United States, 92708
Actively Recruiting
4
University Of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
5
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
6
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
7
Kaiser Permanente Southern California
Riverside, California, United States, 92505
Actively Recruiting
8
Sharp Center for Research
San Diego, California, United States, 92123
Actively Recruiting
9
Providence Saint John s Health Center
Santa Monica, California, United States, 90404
Actively Recruiting
10
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Actively Recruiting
11
Grand Valley Oncology
Grand Junction, Colorado, United States, 81505
Actively Recruiting
12
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Actively Recruiting
13
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
14
Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
15
Duly Health and Care
Lisle, Illinois, United States, 60532
Actively Recruiting
16
Cancer Center of Kansas Heritage Plaza Medical Building
Wichita, Kansas, United States, 67214
Actively Recruiting
17
St Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
18
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
19
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
Actively Recruiting
20
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
21
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
22
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
Actively Recruiting
23
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Actively Recruiting
24
Profound Research LLC at Cancer and Leukemia Center
Sterling Heights, Michigan, United States, 48314
Actively Recruiting
25
HealthPartners Frauenshuh Cancer Center CRC West
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
26
HealthPartners Cancer Center at Regions Hospital CRC East
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
27
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
28
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States, 68506
Actively Recruiting
29
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
30
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
31
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
32
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
33
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
34
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
35
Oregon Urology Institute
Springfield, Oregon, United States, 97477
Actively Recruiting
36
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
37
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
38
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
39
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
40
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
41
Avera Medical Group
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
42
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Actively Recruiting
43
Texas Oncology
Austin, Texas, United States, 78731
Actively Recruiting
44
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
45
Houston Metro Urology
Houston, Texas, United States, 77027
Actively Recruiting
46
Texas Oncology 1
Sugar Land, Texas, United States, 77479
Actively Recruiting
47
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
48
Fred Hutch Cancer Center Sloan Clinic 2
Seattle, Washington, United States, 98109
Actively Recruiting
49
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
50
Warringal Private Hospital
Heidelberg, Australia, 3084
Actively Recruiting
51
Icon Cancer Centre Kurralta Park
Kurralta Park, Australia, 5037
Actively Recruiting
52
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
53
Sydney Adventist Hospital
Wahroonga, Australia, 2076
Actively Recruiting
54
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
55
AZORG campus Aalst Moorselbaan
Aalst, Belgium, 9300
Actively Recruiting
56
ZAS Augustinus
Antwerp, Belgium, 2610
Actively Recruiting
57
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
58
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, Belgium, 7100
Actively Recruiting
59
CHC MontLegia
Liège, Belgium, 4000
Actively Recruiting
60
NAIC Nair Antunes Instituto do Cancer
Bauru, Brazil, 17033-495
Actively Recruiting
61
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062 000
Actively Recruiting
62
Hospital Ana Nery Santa Cruz do Sul
Santa Cruz do Sul, Brazil, 96835-100
Actively Recruiting
63
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, Brazil, 09060 870
Actively Recruiting
64
ESHO Empresa De Servicos Hospitalares S A
São Paulo, Brazil, 01232 010
Actively Recruiting
65
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
66
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
67
Centre de Recherche du CHUM
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
68
CHU de Quebec Universite Laval
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
69
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
70
Beijing Luhe Hospital, Capital Medical University
Beijing, China, 101100
Actively Recruiting
71
The Third People's Hospital of Chengdu
Chengdu, China, 610014
Actively Recruiting
72
West China Hospital Sichuan University
Chengdu, China, 610041
Actively Recruiting
73
Chongqing University Cancer Hospital
Chongqing, China, 400030
Actively Recruiting
74
Sun Yat Sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
75
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510120
Actively Recruiting
76
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China, 310009
Actively Recruiting
77
Nanjing Drum Tower Hospital
Nanjing, China, 210009
Actively Recruiting
78
Huashan Hospital Fudan University
Shanghai, China, 200031
Actively Recruiting
79
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
80
The Second Hospital Of Tianjin Medical University
Tianjin, China, 300211
Actively Recruiting
81
The Central Hospital of Wuhan
Wuhan, China, 430014
Actively Recruiting
82
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China, 710061
Actively Recruiting
83
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
84
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
85
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
86
Groupe Hospitalo-Universitaire Carémeau
Nîmes, France, 30900
Actively Recruiting
87
Hopital Europeen Georges-Pompidou
Paris, France, 75908
Actively Recruiting
88
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
89
Urologicum Duisburg
Duisburg, Germany, 47169
Actively Recruiting
90
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
91
Studienpraxis Urologie Drs. Feyerabend
Nürtingen, Germany, 72622
Actively Recruiting
92
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
93
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
94
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
95
Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Actively Recruiting
96
Juntendo University Hospital
Bunkyō City, Japan, 113 8431
Actively Recruiting
97
Kansai Medical University Hospital
Hirakata, Japan, 573-1191
Actively Recruiting
98
Kanazawa University Hospital
Kanazawa, Japan, 920 8641
Actively Recruiting
99
Kitasato University Hospital
Sagamihara, Japan, 252-0375
Actively Recruiting
100
Shizuoka Cancer Center
Sunto Gun, Japan, 411 8777
Actively Recruiting
101
Yokohama City University Medical Center
Yokohama, Japan, 232 0024
Actively Recruiting
102
Hospital Wanita dan Kanak-Kanak Sabah
Kota Kinabalu, Malaysia, 88996
Actively Recruiting
103
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Actively Recruiting
104
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
105
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
106
Hospital Umum Sarawak
Kuching, Malaysia, 93586
Actively Recruiting
107
Pan American Center for Oncology Trials LLC
San Juan, Puerto Rico, 935
Actively Recruiting
108
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
109
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
110
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
111
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
112
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea, 06591
Actively Recruiting
113
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
114
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
115
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
116
Hosp. Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
117
Hosp. Gral. Univ. Valencia
Valencia, Spain, 46014
Actively Recruiting
118
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
119
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
120
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
121
Tungs' Taichung MetroHarbor Hospital
Taichung, Taiwan, 435
Actively Recruiting
122
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
123
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
124
Adana City Hospital
Adana, Turkey (Türkiye), 01170
Actively Recruiting
125
Gulhane Training and Research Hospital
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
126
Ankara University Medical Faculty
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
127
Istanbul University Cerrahpasa tip Fakultesi
Istanbul, Turkey (Türkiye), 34096
Actively Recruiting
128
Koc Universitesi Hastanesi
Istanbul, Turkey (Türkiye), 34147
Actively Recruiting
129
Medicana International Izmir
Izmir, Turkey (Türkiye), 35170
Actively Recruiting
130
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
131
Beatson West Of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
132
St Bartholomews Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
133
The Royal Marsden NHS Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
134
The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
135
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Actively Recruiting
136
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study 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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