110
Participants
Start Date
January 25, 2022
Primary Completion Date
December 8, 2023
Study Completion Date
January 31, 2028
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.
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).
Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator (Post taxane population only)
RECRUITING
Novartis Investigative Site, Kashiwa
RECRUITING
Novartis Investigative Site, Fukushima
RECRUITING
Novartis Investigative Site, Sapporo
RECRUITING
Novartis Investigative Site, Kobe
RECRUITING
Novartis Investigative Site, Kanazawa
RECRUITING
Novartis Investigative Site, Yokohama
RECRUITING
Novartis Investigative Site, Chiba
RECRUITING
Novartis Investigative Site, Kyoto
Lead Sponsor
Eckert & Ziegler Radiopharma GmbH
UNKNOWN
Novartis Pharmaceuticals
INDUSTRY