NCT05658003 - A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 5, 2023

Primary Completion Date

December 2, 2024

Study Completion Date

January 13, 2027

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

DRUG

[177Lu]Lu-PSMA-617

administered intravenously once every 6 weeks (1 cycle) for 6 cycles

DRUG

ARDT

administered orally on a continuous basis, as per package insert and guidelines

DRUG

[68Ga]Ga-PSMA-11

single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi).

OTHER

Best supportive care

Best supportive/best standard of care as defined by the local investigator

Trial Locations (15)

100034

Novartis Investigative Site, Beijing

100036

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

110011

Novartis Investigative Site, Shenyang

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

210006

Novartis Investigative Site, Nanjing

210029

Novartis Investigative Site, Nanjing

300308

Novartis Investigative Site, Tianjin

310003

Novartis Investigative Site, Hangzhou

430022

Novartis Investigative Site, Wuhan

510060

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

710032

Novartis Investigative Site, Xian

710061

Novartis Investigative Site, Xian