Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan

PHASE2RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

January 25, 2022

Primary Completion Date

December 8, 2023

Study Completion Date

January 31, 2028

Conditions
Prostate Cancer
Interventions
RADIATION

177Lu-PSMA-617

administered intravenously at a dose of 7.4 GBq (+/- 10%). 7.4 GBq dose is equivalent to 200 mCi or 7400 MBq.

RADIATION

68Ga-PSMA-11

68Ga-PSMA-11 is manufactured by radiolabeling of PSMA-11 precursor with 68Ga directly at clinical trial sites immediately prior to administration into participants. The 68Ga used for radiolabeling will be eluted from the 68Ge/68Ga generator. 68Ga-PSMA-11 will be prepared as a sterile solution and administered intravenously at a dose of 111 - 259 MBq (3 - 7 mCi).

OTHER

Best supportive/best standard of care

Best supportive/best standard of care as defined by the local investigator (Post taxane population only)

Trial Locations (8)

277 8577

RECRUITING

Novartis Investigative Site, Kashiwa

960 1295

RECRUITING

Novartis Investigative Site, Fukushima

060 8648

RECRUITING

Novartis Investigative Site, Sapporo

650-0047

RECRUITING

Novartis Investigative Site, Kobe

920 8641

RECRUITING

Novartis Investigative Site, Kanazawa

236-0004

RECRUITING

Novartis Investigative Site, Yokohama

260-8717

RECRUITING

Novartis Investigative Site, Chiba

606 8507

RECRUITING

Novartis Investigative Site, Kyoto

Sponsors
All Listed Sponsors
collaborator

Eckert & Ziegler Radiopharma GmbH

UNKNOWN

lead

Novartis Pharmaceuticals

INDUSTRY