Actively Recruiting
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
Led by Novartis Pharmaceuticals · Updated on 2026-04-30
450
Participants Needed
142
Research Sites
394 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
CONDITIONS
Official Title
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate cancer before randomization
- Biochemical recurrence after definitive primary treatment such as radical prostatectomy or radiation therapy
- 1 to 5 PSMA-positive metastatic lesions on PET/CT scan as assessed by a blinded independent review committee
- At least one PSMA-positive lesion must be a distant metastasis (M1) per AJCC 8 classification
- Negative conventional imaging for M1 disease at screening
- All metastatic lesions must be suitable for stereotactic body radiation therapy (SBRT)
- Testosterone level above 100 ng/dL at screening
- Participants with pelvic disease below the common iliac bifurcation are allowed
You will not qualify if you...
- De novo oligometastatic prostate cancer at screening
- Unmanageable bladder outflow obstruction or urinary incontinence
- Prior use of androgen deprivation therapy or androgen receptor pathway inhibitors for metastatic prostate cancer within 12 months before randomization
- Use of other hormonal therapies for prostate cancer, radiopharmaceutical agents, immunotherapy, chemotherapy (except completed adjuvant/neoadjuvant more than 12 months prior), or other investigational treatments for metastatic disease
- External beam radiation therapy or brachytherapy within 28 days before randomization
- Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy, PARP inhibitors, biological therapy, or investigational therapy
- Diagnosis of other malignancies expected to affect life expectancy or interfere with disease assessments unless adequately treated and disease-free for over 3 years
- Significant cardiac abnormalities posing safety risks such as certain arrhythmias or heart blocks without pacemaker
- Immediate need for androgen deprivation therapy as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 142 locations
1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
2
VA Greater LA Healthcare System
Los Angeles, California, United States, 90073
Actively Recruiting
3
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1207
Actively Recruiting
4
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
5
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
6
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
7
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Actively Recruiting
8
Woodlands Medical Specialists
Pensacola, Florida, United States, 32503
Actively Recruiting
9
Piedmont Healthcare
Atlanta, Georgia, United States, 30318
Actively Recruiting
10
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
11
The Cancer Institute of Alexian Brothers
Elk Grove, Illinois, United States, 60007
Actively Recruiting
12
Unity Point Clinic
Des Moines, Iowa, United States, 50323
Actively Recruiting
13
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
14
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
15
East Jefferson Hospital
Metairie, Louisiana, United States, 70006
Actively Recruiting
16
University of Maryland Medical Ctr
Baltimore, Maryland, United States, 21201
Actively Recruiting
17
Johns Hopkins Kimmel Com Cancer Ctr
Baltimore, Maryland, United States, 21231
Actively Recruiting
18
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
19
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Actively Recruiting
20
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
21
Profound Research LLC
Royal Oak, Michigan, United States, 48073
Active, Not Recruiting
22
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
23
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
24
VA St Louis Health Care System
St Louis, Missouri, United States, 63106
Actively Recruiting
25
Wash U School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
26
The Urology Center PC DBA UroHealth Partners
Omaha, Nebraska, United States, 68114
Actively Recruiting
27
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States, 10065
Actively Recruiting
28
Associated Med Professionals of NY
Syracuse, New York, United States, 13210
Actively Recruiting
29
Montefiore Hospital
The Bronx, New York, United States, 10467 2490
Actively Recruiting
30
East Carolina University
Greenville, North Carolina, United States, 27858
Actively Recruiting
31
Dayton Physicians
Kettering, Ohio, United States, 45409
Actively Recruiting
32
Oregon Urology Institute
Springfield, Oregon, United States, 97477
Actively Recruiting
33
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
34
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
35
Univ of Texas Southwest Med Center
Dallas, Texas, United States, 75390-9034
Actively Recruiting
36
Rio Grande Urology
El Paso, Texas, United States, 79912
Actively Recruiting
37
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
38
Blue Ridge Cancer Center
Wytheville, Virginia, United States, 24382
Actively Recruiting
39
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
40
Novartis Investigative Site
CABA, Argentina, C1181ACH
Actively Recruiting
41
Novartis Investigative Site
Caba, Argentina, C1431FWO
Actively Recruiting
42
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
43
Novartis Investigative Site
Herston, Queensland, Australia, 4029
Actively Recruiting
44
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
45
Novartis Investigative Site
Malvern, Victoria, Australia, 3144
Actively Recruiting
46
Novartis Investigative Site
Linz, Austria, 4020
Actively Recruiting
47
Novartis Investigative Site
Vienna, Austria, 1090
Actively Recruiting
48
Novartis Investigative Site
Aalst, Belgium, 9300
Actively Recruiting
49
Novartis Investigative Site
Ghent, Belgium, 9000
Actively Recruiting
50
Novartis Investigative Site
Wilrijk, Belgium, 2610
Actively Recruiting
51
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01246 000
Actively Recruiting
52
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
53
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
54
Novartis Investigative Site
London, Ontario, Canada, N6A 4G5
Actively Recruiting
55
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
56
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
57
Novartis Investigative Site
Montreal, Quebec, Canada, H2X 1R9
Actively Recruiting
58
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
59
Novartis Investigative Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
60
Novartis Investigative Site
Beijing, China, 100036
Actively Recruiting
61
Novartis Investigative Site
Guangzhou, China, 510060
Actively Recruiting
62
Novartis Investigative Site
Shanghai, China, 200127
Actively Recruiting
63
Novartis Investigative Site
Ostrava, Poruba, Czechia, 708 52
Actively Recruiting
64
Novartis Investigative Site
Olomouc, Czechia, 779 00
Actively Recruiting
65
Novartis Investigative Site
Prague, Czechia, 150 06
Actively Recruiting
66
Novartis Investigative Site
Saint-Cloud, Hauts De Seine, France, 92210
Actively Recruiting
67
Novartis Investigative Site
Angers, France, 49055
Actively Recruiting
68
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
69
Novartis Investigative Site
Bron, France, 69677
Actively Recruiting
70
Novartis Investigative Site
Clermont-Ferrand, France, 63011
Actively Recruiting
71
Novartis Investigative Site
Rouen, France, 76038
Actively Recruiting
72
Novartis Investigative Site
Saint-Herblain, France, 44805
Actively Recruiting
73
Novartis Investigative Site
Munich, Bavaria, Germany, 81377
Actively Recruiting
74
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
75
Novartis Investigative Site
Aachen, Germany, 52074
Actively Recruiting
76
Novartis Investigative Site
Augsburg, Germany, 86179
Actively Recruiting
77
Novartis Investigative Site
Berlin, Germany, 10249
Actively Recruiting
78
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
79
Novartis Investigative Site
Münster, Germany, 48149
Actively Recruiting
80
Novartis Investigative Site
Rostock, Germany, 18057
Actively Recruiting
81
Novartis Investigative Site
Athens, Greece, 106 76
Actively Recruiting
82
Novartis Investigative Site
Athens, Greece, 11528
Actively Recruiting
83
Novartis Investigative Site
Thessaloniki, Greece, 540 07
Actively Recruiting
84
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
85
Novartis Investigative Site
Budapest, Hungary, H 1122
Actively Recruiting
86
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
87
Novartis Investigative Site
Beersheba, Israel, 8457108
Actively Recruiting
88
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
89
Novartis Investigative Site
Jerusalem, Israel, 9112001
Actively Recruiting
90
Novartis Investigative Site
Petah Tikva, Israel, 4941492
Actively Recruiting
91
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
92
Novartis Investigative Site
Brescia, BS, Italy, 25123
Actively Recruiting
93
Novartis Investigative Site
Cona, FE, Italy, 44124
Actively Recruiting
94
Novartis Investigative Site
Genova, GE, Italy, 16132
Actively Recruiting
95
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Actively Recruiting
96
Novartis Investigative Site
Pisa, PI, Italy, 56126
Actively Recruiting
97
Novartis Investigative Site
Roma, RM, Italy, 00168
Actively Recruiting
98
Novartis Investigative Site
Negrar, VR, Italy, 37024
Actively Recruiting
99
Novartis Investigative Site
Milan, Italy, 20141
Actively Recruiting
100
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
101
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
102
Novartis Investigative Site
Kobe, Hyōgo, Japan, 6500047
Actively Recruiting
103
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
104
Novartis Investigative Site
Chuo Ku, Tokyo, Japan, 1040045
Actively Recruiting
105
Novartis Investigative Site
Fukuoka, Japan, 811-0213
Actively Recruiting
106
Novartis Investigative Site
Fukuoka, Japan, 812-0033
Actively Recruiting
107
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
108
Novartis Investigative Site
Fukushima, Japan, 9601295
Actively Recruiting
109
Novartis Investigative Site
Ishikawa, Japan, 9208641
Actively Recruiting
110
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
111
Novartis Investigative Site
Petaling Jaya, Selangor, Malaysia, 46050
Actively Recruiting
112
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
113
Novartis Investigative Site
Mexico City, Mexico City, Mexico, 14050
Actively Recruiting
114
Novartis Investigative Site
Huxquilucan, Mexico, 52763
Actively Recruiting
115
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
116
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
Actively Recruiting
117
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
118
Novartis Investigative Site
Singapore, Singapore, 168583
Actively Recruiting
119
Novartis Investigative Site
Bratislava, Slovakia, 83310
Actively Recruiting
120
Novartis Investigative Site
Košice, Slovakia, 041 91
Actively Recruiting
121
Novartis Investigative Site
Nitra, Slovakia, 949 01
Actively Recruiting
122
Novartis Investigative Site
Trenčín, Slovakia, 911 01
Actively Recruiting
123
Novartis Investigative Site
Granada, Andalusia, Spain, 18014
Actively Recruiting
124
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08025
Actively Recruiting
125
Novartis Investigative Site
El Palmar, Murcia, Spain, 30120
Actively Recruiting
126
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
127
Novartis Investigative Site
Madrid, Spain, 28040
Actively Recruiting
128
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
129
Novartis Investigative Site
Seville, Spain, 41013
Actively Recruiting
130
Novartis Investigative Site
Valencia, Spain, 46010
Actively Recruiting
131
Novartis Investigative Site
Geneva, Switzerland, 1211
Actively Recruiting
132
Novartis Investigative Site
Lucerne, Switzerland, 6006
Actively Recruiting
133
Novartis Investigative Site
Zurich, Switzerland, 8063
Actively Recruiting
134
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
135
Novartis Investigative Site
Taipei, Taiwan, 103616
Actively Recruiting
136
Novartis Investigative Site
Taipei, Taiwan, 11217
Actively Recruiting
137
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Actively Recruiting
138
Novartis Investigative Site
Bristol, Avon, United Kingdom, BS2 8ED
Actively Recruiting
139
Novartis Investigative Site
Guildford, Surrey, United Kingdom, GU2 7XX
Actively Recruiting
140
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
141
Novartis Investigative Site
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
142
Novartis Investigative Site
London, United Kingdom, NW3 2QG
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
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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