Actively Recruiting
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
Led by Novartis Pharmaceuticals · Updated on 2026-04-30
443
Participants Needed
72
Research Sites
437 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
CONDITIONS
Official Title
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Male participants
- ECOG performance status of 0 to 2
- Histopathological or cytological confirmation of prostate adenocarcinoma
- PSMA-positive disease confirmed by PSMA PET/CT scan
- Castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Prior treatment with androgen receptor pathway inhibitor and taxane-based chemotherapy
- Disease progression on or after [177Lu]Lu-PSMA targeted therapy
- At least one metastatic lesion visible on recent imaging (CT, MRI, or bone scan within 28 days prior to randomization)
- Adequate kidney function as requested by the sponsor
You will not qualify if you...
- Use of any investigational agents within 28 days before randomization
- Use of any 225Ac-based investigational compounds before randomization
- History of CNS metastases if neurologically unstable, symptomatic, or requiring corticosteroids for neurological stability
- Current acute kidney injury or chronic kidney disease ongoing for at least 3 months
- Baseline xerostomia of Grade 2 or higher
- History of uncontrolled hypertension, recent myocardial infarction, angina, or coronary artery bypass graft within 6 months prior to consent
- Clinically active significant heart disease
- History of lymphoproliferative disease or other malignancies within the past 5 years, except certain treated skin cancers or non-invasive colon polyps without recurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 72 locations
1
VA Greater LA Healthcare System
Los Angeles, California, United States, 90073
Actively Recruiting
2
Stanford University Medical Center
Palo Alto, California, United States, 94304
Actively Recruiting
3
Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
4
Saint Johns Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
5
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
6
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
7
University Cancer and Blood Center LLC
Athens, Georgia, United States, 30607
Actively Recruiting
8
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
11
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
WA Uni School Of Med
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68154
Actively Recruiting
14
New Jersey Urology LLC
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
15
Associated Med Professionals of NY
Syracuse, New York, United States, 13210
Actively Recruiting
16
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
17
Central Ohio Urology Group
Gahanna, Ohio, United States, 43230
Actively Recruiting
18
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
19
Texas Oncology
Dallas, Texas, United States, 75251
Actively Recruiting
20
Urology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
21
Utah Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
22
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
23
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
24
Novartis Investigative Site
Herston, Queensland, Australia, 4029
Actively Recruiting
25
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
26
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
27
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05652-000
Actively Recruiting
28
Novartis Investigative Site
Fuzhou, Fujian, China, 350025
Actively Recruiting
29
Novartis Investigative Site
Wuhan, Hubei, China, 430022
Actively Recruiting
30
Novartis Investigative Site
Wuhan, Hubei, China, 430030
Actively Recruiting
31
Novartis Investigative Site
Nanjing, Jiangsu, China, 210006
Actively Recruiting
32
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Actively Recruiting
33
Novartis Investigative Site
Shenyang, Liaoning, China, 110011
Actively Recruiting
34
Novartis Investigative Site
Xian, Shanxi, China, 710032
Actively Recruiting
35
Novartis Investigative Site
Xian, Shanxi, China, 710061
Actively Recruiting
36
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
37
Novartis Investigative Site
Beijing, China, 100034
Actively Recruiting
38
Novartis Investigative Site
Beijing, China, 100036
Actively Recruiting
39
Novartis Investigative Site
Guangzhou, China, 510060
Actively Recruiting
40
Novartis Investigative Site
Shanghai, China, 200025
Actively Recruiting
41
Novartis Investigative Site
Shanghai, China, 200032
Actively Recruiting
42
Novartis Investigative Site
Tianjin, China, 300300
Actively Recruiting
43
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
44
Novartis Investigative Site
Beersheba, Israel, 8457108
Actively Recruiting
45
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
46
Novartis Investigative Site
Petah Tikva, Israel, 4941492
Actively Recruiting
47
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Actively Recruiting
48
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
49
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
50
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
51
Novartis Investigative Site
Kobe, Hyōgo, Japan, 6500047
Actively Recruiting
52
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
53
Novartis Investigative Site
Chiba, Japan, 260-8717
Actively Recruiting
54
Novartis Investigative Site
Fukuoka, Japan, 812-0033
Actively Recruiting
55
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
56
Novartis Investigative Site
Fukushima, Japan, 9601295
Actively Recruiting
57
Novartis Investigative Site
Ishikawa, Japan, 9208641
Actively Recruiting
58
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
59
Novartis Investigative Site
Petaling Jaya, Selangor, Malaysia, 46050
Actively Recruiting
60
Novartis Investigative Site
Singapore, Singapore, 119228
Actively Recruiting
61
Novartis Investigative Site
Singapore, Singapore, 168583
Actively Recruiting
62
Novartis Investigative Site
Singapore, Singapore, 258499
Actively Recruiting
63
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
64
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
65
Novartis Investigative Site
Seoul, South Korea, 05505
Actively Recruiting
66
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
67
Novartis Investigative Site
Basel, Switzerland, 4031
Actively Recruiting
68
Novartis Investigative Site
Bern, Switzerland, 3010
Actively Recruiting
69
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
70
Novartis Investigative Site
Taipei, Taiwan, 103616
Actively Recruiting
71
Novartis Investigative Site
Taipei, Taiwan, 11217
Actively Recruiting
72
Novartis Investigative Site
Taoyuan, Taiwan, 33305
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
4
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