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

PHASE3RecruitingINTERVENTIONAL
Enrollment

605

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

February 29, 2028

Study Completion Date

November 4, 2032

Conditions
Prostate Cancer
Interventions
DRUG

AAA817

AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy.

DRUG

ARPI

Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone.

DRUG

Standard of Care

Standard treatment includes approved treatment for mCRPC. In this trial, the trial doctor will decide which available treatment participants will receive. The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel.

Trial Locations (22)

2010

RECRUITING

Novartis Investigative Site, Darlinghurst

5000

RECRUITING

Novartis Investigative Site, Adelaide

33305

RECRUITING

Novartis Investigative Site, Taoyuan District

66160

RECRUITING

University of Kansas Hospital, Kansas City

100036

RECRUITING

Novartis Investigative Site, Beijing

110011

RECRUITING

Novartis Investigative Site, Shenyang

119074

RECRUITING

Novartis Investigative Site, Singapore

169608

RECRUITING

Novartis Investigative Site, Singapore

200032

RECRUITING

Novartis Investigative Site, Shanghai

200127

RECRUITING

Novartis Investigative Site, Shanghai

210029

RECRUITING

Novartis Investigative Site, Nanjing

430022

RECRUITING

Novartis Investigative Site, Wuhan

510060

RECRUITING

Novartis Investigative Site, Guangzhou

510632

RECRUITING

Novartis Investigative Site, Guangzhou

610041

RECRUITING

Novartis Investigative Site, Chengdu

999077

RECRUITING

Novartis Investigative Site, Pokfulam

060 8648

RECRUITING

Novartis Investigative Site, Sapporo

650-0047

RECRUITING

Novartis Investigative Site, Kobe

236-0004

RECRUITING

Novartis Investigative Site, Yokohama

260-8717

RECRUITING

Novartis Investigative Site, Chiba

811-0213

RECRUITING

Novartis Investigative Site, Fukuoka

SM2 5PT

RECRUITING

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY