Clinical trialNCT06855277RecruitingPhase 3Interventional

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

SponsorNovartis PharmaceuticalsEnrollment940Prostate Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

92 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Recruiting
Novartis Investigative Site
Adelaide, South Australia, Australia
Recruiting
Novartis Investigative Site
Malvern, Victoria, Australia
Recruiting
Novartis Investigative Site
Murdoch, Western Australia, Australia
Recruiting
Novartis Investigative Site
Adelaide, Australia
Recruiting

Brazil

Novartis Investigative Site
São Paulo, São Paulo, Brazil
Recruiting
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Recruiting

China

Novartis Investigative Site
Fuzhou, Fujian, China
Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, China
Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, China
Recruiting
Novartis Investigative Site
Wuhan, Hubei, China
Recruiting
Novartis Investigative Site
Wuhan, Hubei, China
Recruiting
Novartis Investigative Site
Nanjing, Jiangsu, China
Recruiting
Novartis Investigative Site
Nanjing, Jiangsu, China
Recruiting
Novartis Investigative Site
Shenyang, Liaoning, China
Recruiting
Novartis Investigative Site
Chengdu, Sichuan, China
Recruiting
Novartis Investigative Site
Hangzhou, Zhejiang, China
Recruiting
Novartis Investigative Site
Hangzhou, Zhejiang, China
Recruiting
Novartis Investigative Site
Beijing, China
Recruiting
Novartis Investigative Site
Beijing, China
Recruiting
Novartis Investigative Site
Guangzhou, China
Recruiting
Novartis Investigative Site
Shanghai, China
Recruiting
Novartis Investigative Site
Shanghai, China
Recruiting
Novartis Investigative Site
Shanghai, China
Recruiting
Novartis Investigative Site
Tianjin, China
Recruiting
Novartis Investigative Site
Tianjin, China
Recruiting

Hong Kong

Novartis Investigative Site
Hong Kong, Hong Kong
Recruiting

India

Novartis Investigative Site
Gurgaon, Haryana, India
Recruiting
Novartis Investigative Site
Bengaluru, Karnataka, India
Recruiting
Novartis Investigative Site
Mumbai, Maharashtra, India
Recruiting

Japan

Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Recruiting
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Recruiting
Novartis Investigative Site
Kobe, Hyōgo, Japan
Recruiting
Novartis Investigative Site
Kobe, Hyōgo, Japan
Recruiting
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Recruiting
Novartis Investigative Site
Chiba, Japan
Recruiting
Novartis Investigative Site
Fukuoka, Japan
Recruiting
Novartis Investigative Site
Fukuoka, Japan
Recruiting
Novartis Investigative Site
Fukuoka, Japan
Recruiting

52 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Actinium(225Ac) Vipivotide Tetraxetan →ARPI →Standard of Care

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jul 2025
Primary completion: 29 Sept 2028
Completion: 4 Nov 2032
Last update posted: 19 Aug 2026
Registered enrollment: 940
Registry id: NCT06855277

Cross-registrations

EU-CTR / CTIS (EudraCT)2024-512340-32

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.