Actively Recruiting
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, plus Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
663
Participants Needed
168
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pasritamig (JNJ-78278343), a T cell redirecting agent targeting human kallikrein 2, combined with best supportive care (BSC) for men with metastatic castration-resistant prostate cancer (mCRPC). This advanced cancer stage has spread beyond the prostate and no longer responds to hormone treatments. The study compares pasritamig plus BSC to a placebo plus BSC to assess overall survival in patients who have exhausted other life-prolonging therapies. Participants receive pasritamig or placebo through intravenous infusions starting with step-up doses on Cycle 1 Day 1 and Day 8, followed by the target dose on Day 15. Subsequent doses occur every 6 weeks in 6-week cycles, except the first cycle which lasts 8 weeks. All participants may receive best supportive care, including palliative radiation, steroids, pain medications, bone agents, and procedures, as determined by their doctors. Treatment continues until disease progression, intolerable side effects, death, withdrawal, or study end. During the study, participants undergo regular assessments to monitor overall survival and other outcomes like progression-free survival, symptom progression, skeletal events, pain, fatigue, and adverse events. These evaluations may include imaging, laboratory tests, and quality of life questionnaires over approximately 2 years and 8 months. Safety and treatment effects will be closely followed throughout the trial.
CONDITIONS
Brief Title
A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate
- Metastatic castration-resistant prostate cancer with metastases to bone and/or lymph nodes confirmed by imaging
- PSA level of 2 ng/mL or higher at screening
- Investigator's opinion that clinical trial is the next best treatment option
- Prior treatment with androgen-receptor pathway inhibitor with progression and unlikely benefit from retreatment
- Prior treatment with at least two taxane-based chemotherapy regimens, or eligible exceptions if only one regimen received
- Prior treatment with PSMA-targeted lutetium radioligand therapy if available and clinically indicated
- Prior treatment with PARP inhibitors if BRCA mutation is present and therapy is available
- Prior orchiectomy or ongoing medical castration with GnRH analog before study treatment and continuation throughout
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate kidney function (eGFR ≥ 30 mL/min)
- Liver enzymes ALT and AST ≤ 5 times upper limit of normal
- Total bilirubin ≤ 3 times upper limit of normal
- Absolute neutrophil count ≥ 1.0 x10^9/L
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 75 x10^9/L
You will not qualify if you...
- Venous thromboembolic events within 1 month before first study dose (except uncomplicated Grade ≤ 2 deep vein thrombosis)
- Active autoimmune disease within past 12 months requiring systemic immunosuppressive medications
- Fever (≥ 38°C) or active infection needing systemic treatment within 7 days prior to randomization
- Need for supplemental oxygen > 2 L/min to maintain oxygenation
- Prior or concurrent second cancer likely to interfere with study outcomes
- Myocardial infarction, severe angina, significant ventricular arrhythmias, congestive heart failure (NYHA class II-IV), transient ischemic attack, or stroke within 6 months before first dose
- Prior treatment with any CD3-directed therapy
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 2 years and 8 months
Participants receive step-up doses of pasritamig or placebo via intravenous infusion in the first 8 weeks, followed by target dose infusions every 6 weeks. Treatment continues until confirmed disease progression, death, intolerable toxicity, withdrawal of consent, or study end. Best Supportive Care (BSC) is provided as needed by the treating physician.
Infusions every 6 weeks after initial dosing period
Trial Site Locations
Total: 168 locations
1
University of California at San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Actively Recruiting
4
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Actively Recruiting
6
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
7
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
8
Bay Pines VA Healthcare System
Bay Pines, Florida, United States, 33744
Actively Recruiting
9
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States, 33901
Actively Recruiting
10
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
11
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
12
Mission Cancer Blood
Waukee, Iowa, United States, 50263
Actively Recruiting
13
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
Actively Recruiting
14
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
15
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
17
Henry Ford Cancer Detroit
Detroit, Michigan, United States, 48202
Actively Recruiting
18
University Of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
19
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States, 68130
Actively Recruiting
20
NYU Langone Hospitals
Brooklyn, New York, United States, 11220
Actively Recruiting
21
NYU Langone Hospital Long Island
Mineola, New York, United States, 11501
Actively Recruiting
22
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
23
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
24
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
25
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
26
Compass Oncology
Portland, Oregon, United States, 97227
Actively Recruiting
27
VA Portland Health Care System
Portland, Oregon, United States, 97239
Actively Recruiting
28
Oregon Urology Institute
Springfield, Oregon, United States, 97477
Actively Recruiting
29
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
30
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
31
Penn Medicine Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
32
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
33
Ralph H Johnson Veterans Hospital
Charleston, South Carolina, United States, 29401
Actively Recruiting
34
Gibbs Cancer Center and Research Institute Pelham
Greer, South Carolina, United States, 29650
Actively Recruiting
35
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
36
Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
37
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
38
Tennessee Oncology Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
39
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Actively Recruiting
40
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
41
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
42
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
43
Texas Oncology West Texas
Wichita Falls, Texas, United States, 76310
Actively Recruiting
44
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Actively Recruiting
45
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
46
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
47
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
48
VA Puget Sound Healthcare System
Seattle, Washington, United States, 98108
Actively Recruiting
49
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
50
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
51
Warringal Private Hospital
Heidelberg, Australia, 3084
Actively Recruiting
52
ICON Cancer Care
Kurralta Park, Australia, 5037
Actively Recruiting
53
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
54
Fiona Stanley Hospital
Murdoch, Australia, 6150
Actively Recruiting
55
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
56
AZ Sint-Jan
Bruges, Belgium, 8000
Actively Recruiting
57
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
58
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
59
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
60
Az Groeninge
Kortrijk, Belgium, 8500
Actively Recruiting
61
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, Belgium, 7100
Actively Recruiting
62
CHC MontLegia
Liège, Belgium, 4000
Actively Recruiting
63
Clinique Saint Pierre
Ottignies, Belgium, 1340
Actively Recruiting
64
ZAS Augustinus
Wilrijk, Belgium, 2610
Actively Recruiting
65
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, Brazil, 88034 000
Actively Recruiting
66
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Joinville, Brazil, 89201 260
Actively Recruiting
67
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062 000
Actively Recruiting
68
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90560032
Actively Recruiting
69
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil, 01509 900
Actively Recruiting
70
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
71
BC Cancer Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
72
Lakeridge Health
Oshawa, Ontario, Canada, L1G2B9
Actively Recruiting
73
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
74
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
75
CHU de Quebec Universite Laval
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
76
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
77
The First Bethune Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
78
The Third People's Hospital of Chengdu
Chengdu, China, 500643
Actively Recruiting
79
West China Hospital of Sichuan University
Chengdu, China, 610041
Actively Recruiting
80
Chongqing University Cancer Hospital
Chongqing, China, 400030
Actively Recruiting
81
Sun Yat Sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
82
Nanjing Drum Tower Hospital
Nanjing, China, 210008
Actively Recruiting
83
The First Affiliated Hospital of Guangxi Medical University
Nanning, China, 530021
Actively Recruiting
84
Nantong Tumor Hospital
Nantong, China, 226300
Actively Recruiting
85
The First Affiliated Hospital of Ningbo University
Ningbo, China, 315010
Actively Recruiting
86
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
87
The Second Hospital Of Tianjin Medical University
Tianjin, China, 300211
Actively Recruiting
88
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
89
Zhongnan Hospital Wu Han University
Wuhan, China, 430071
Actively Recruiting
90
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China, 710061
Actively Recruiting
91
Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
92
CHRU Brest - Hopital Morvan
Brest, France, 29200
Actively Recruiting
93
Centre Georges Francois Leclerc
Dijon, France, 21000
Actively Recruiting
94
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
95
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
96
Hopital Saint Joseph
Paris, France, 75014
Actively Recruiting
97
CHU Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
98
I.C.O. Rene Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
99
Hopitaux universitaires de Strasbourg
Strasbourg, France, 672098
Actively Recruiting
100
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
101
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
102
Staedtisches Klinikum Braunschweig
Braunschweig, Germany, 38126 DE
Actively Recruiting
103
Urologicum Duisburg
Duisburg, Germany, 47169
Actively Recruiting
104
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
105
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
106
Krankenhaus NorthWest
Frankfurt am Main, Germany, 60488
Actively Recruiting
107
Martini-Klinik am UKE GmbH
Hamburg, Germany, 20246
Actively Recruiting
108
Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen
Heidelberg, Germany, 69120
Actively Recruiting
109
Klinikum rechts der Isar der TU Muenchen
München, Germany, 81675
Actively Recruiting
110
Universitaetsklinikum Muenster
Münster, Germany, 48149
Actively Recruiting
111
Klinikum Nuernberg Nord
Nuremberg, Germany, 90419
Actively Recruiting
112
Studienpraxis Urologie Nurtingen
Nürtingen, Germany, 72622
Actively Recruiting
113
Ospedali Riuniti Foggia
Foggia, Italy, 71122
Actively Recruiting
114
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
115
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
Actively Recruiting
116
IOV IRCCS Padova
Padova, Italy, 35128
Actively Recruiting
117
Azienda Di Rilievo Nazionale E Di Alta Specializzazione
Palermo, Italy, 90127
Actively Recruiting
118
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
119
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
120
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, Italy, 10126
Actively Recruiting
121
Institute of Science Tokyo Hospital
Bunkyō City, Japan, 113 8519
Actively Recruiting
122
Kyushu University Hospital
Fukuoka, Japan, 812 8582
Actively Recruiting
123
Saitama Medical University International Medical Center
Hidaka, Japan, 350 1298
Actively Recruiting
124
Kanazawa University Hospital
Kanazawa, Japan, 920 8641
Actively Recruiting
125
Kobe University Hospital
Kobe, Japan, 650 0017
Actively Recruiting
126
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan, 791-0280
Actively Recruiting
127
National Hospital Organization Tokyo Medical Center
Meguro Ku, Japan, 152 8902
Actively Recruiting
128
Toho University Sakura Medical Center
Sakura, Japan, 285-8741
Actively Recruiting
129
Yokohama City University Medical Center
Yokohama, Japan, 232 0024
Actively Recruiting
130
Yokohama City University Hospital
Yokohama, Japan, 236 0004
Actively Recruiting
131
Yokosuka Kyosai Hospital
Yokosuka, Japan, 238 8558
Actively Recruiting
132
Reinier de Graaf Gasthuis
Delft, Netherlands, 2625 AD
Actively Recruiting
133
Martini Ziekenhuis
Groningen, Netherlands, 9728NT
Actively Recruiting
134
Tergooi
Hilversum, Netherlands, 1212 VG
Actively Recruiting
135
Spaarne Gasthuis
Hoofddorp, Netherlands, 2134 TM
Actively Recruiting
136
Maastricht UMC
Maastricht, Netherlands, 6229 HX
Actively Recruiting
137
Canisius-Wilhelmina ZH
Nijmegen, Netherlands, 6532 SZ
Actively Recruiting
138
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
139
Isala Kliniek
Zwolle, Netherlands, 8025 AB
Actively Recruiting
140
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15 276
Actively Recruiting
141
IN VIVO Sp. z o.o
Bydgoszcz, Poland, 85 048
Actively Recruiting
142
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
Koszalin, Poland, 75-581
Actively Recruiting
143
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02 781
Actively Recruiting
144
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
Warsaw, Poland, 04 073
Actively Recruiting
145
Pan American Center for Oncology Trials LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
146
Puerto Rico Medical Research Center
San Juan, Puerto Rico, 00917
Actively Recruiting
147
Chungnam National University Hospital
Daejeon, South Korea, 35015
Actively Recruiting
148
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
149
Chonnam National University Hwasun Hospital
Hwasungun, South Korea, 58128
Actively Recruiting
150
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
151
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
152
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
153
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea, 06591
Actively Recruiting
154
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
155
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain, 11407
Actively Recruiting
156
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
157
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
158
Hosp Virgen de La Victoria
Málaga, Spain, 29010
Actively Recruiting
159
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
160
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
161
Tungs' Taichung MetroHarbor Hospital
Taichung, Taiwan, 435
Actively Recruiting
162
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
163
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
164
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
165
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
166
University College London Hospitals
London, United Kingdom, WC1E 6BT
Actively Recruiting
167
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
168
Royal Marsden Hospital (Sutton)
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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