Actively Recruiting
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Led by Novartis Pharmaceuticals · Updated on 2026-02-24
940
Participants Needed
55
Research Sites
383 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.
CONDITIONS
Official Title
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Adults aged 18 years or older
- ECOG performance status between 0 and 2
- Confirmed diagnosis of prostate adenocarcinoma (no mixed neuroendocrine cancer)
- Eligible if previously received taxane chemotherapy for hormone-sensitive prostate cancer but not for metastatic castration resistant prostate cancer
- No prior taxane chemotherapy for metastatic castration resistant prostate cancer
- PSMA-positive disease confirmed by PSMA-PET imaging
- Diagnosed with metastatic castration resistant prostate cancer with disease progression while on ARPI as last treatment
- Participants with certain HRR gene mutations who had prior PARP inhibitor treatment may join
You will not qualify if you...
- Prior treatment with any approved or investigational radiopharmaceuticals like [177Lu]Lu-PSMA or Radium-223
- External beam radiotherapy within 6 weeks before randomization (2 weeks for localized metastases)
- Previous PARP inhibitor or other systemic anticancer therapy for metastatic castration resistant prostate cancer
- Other systemic therapies (chemotherapy, immunotherapy, biologics, monoclonal antibodies) within 28 days or 5 half-lives before randomization
- Mixed neuroendocrine histology prostate cancer
- Prior taxane chemotherapy in metastatic castration resistant prostate cancer setting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 55 locations
1
Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
2
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
3
Miami Cancer Institute at Bapt
Miami, Florida, United States, 33173
Actively Recruiting
4
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
5
Univ Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
Wash U School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Bassett Medical Center
Cooperstown, New York, United States, 13326
Actively Recruiting
9
Weill Cornell Medicine NY-Presb
New York, New York, United States, 10021
Actively Recruiting
10
University of Rochester Medical Ctr
Rochester, New York, United States, 14642
Actively Recruiting
11
Associated Med Professionals of NY
Syracuse, New York, United States, 13210
Actively Recruiting
12
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
13
Urology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
14
Swedish Medical Center
Seattle, Washington, United States, 98122-4379
Actively Recruiting
15
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
16
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
17
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
18
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
19
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05652-000
Actively Recruiting
20
Novartis Investigative Site
Guangzhou, Guangdong, China, 510632
Actively Recruiting
21
Novartis Investigative Site
Wuhan, Hubei, China, 430022
Actively Recruiting
22
Novartis Investigative Site
Wuhan, Hubei, China, 430030
Actively Recruiting
23
Novartis Investigative Site
Nanjing, Jiangsu, China, 210006
Actively Recruiting
24
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Actively Recruiting
25
Novartis Investigative Site
Shenyang, Liaoning, China, 110011
Actively Recruiting
26
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
27
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
28
Novartis Investigative Site
Beijing, China, 100034
Actively Recruiting
29
Novartis Investigative Site
Beijing, China, 100036
Actively Recruiting
30
Novartis Investigative Site
Guangzhou, China, 510060
Actively Recruiting
31
Novartis Investigative Site
Shanghai, China, 200025
Actively Recruiting
32
Novartis Investigative Site
Shanghai, China, 200032
Actively Recruiting
33
Novartis Investigative Site
Shanghai, China, 200127
Actively Recruiting
34
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
35
Novartis Investigative Site
Hong Kong, Hong Kong, 999999
Actively Recruiting
36
Novartis Investigative Site
Gurgaon, Haryana, India, 122 002
Actively Recruiting
37
Novartis Investigative Site
Mumbai, Maharashtra, India, 400 012
Actively Recruiting
38
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608648
Actively Recruiting
39
Novartis Investigative Site
Kobe, Hyōgo, Japan, 6500047
Actively Recruiting
40
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan, 236-0004
Actively Recruiting
41
Novartis Investigative Site
Chuo Ku, Tokyo, Japan, 1040045
Actively Recruiting
42
Novartis Investigative Site
Chiba, Japan, 260-8717
Actively Recruiting
43
Novartis Investigative Site
Fukuoka, Japan, 811-0213
Actively Recruiting
44
Novartis Investigative Site
Fukuoka, Japan, 812-0033
Actively Recruiting
45
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
46
Novartis Investigative Site
Hiroshima, Japan, 7348551
Actively Recruiting
47
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
48
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
49
Novartis Investigative Site
Singapore, Singapore, 168583
Actively Recruiting
50
Novartis Investigative Site
Singapore, Singapore, 169608
Actively Recruiting
51
Novartis Investigative Site
Seoul, Korea, South Korea, 03080
Actively Recruiting
52
Novartis Investigative Site
Seoul, South Korea, 06351
Actively Recruiting
53
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
54
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Actively Recruiting
55
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
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
DIAGNOSTIC
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here