36
Participants
Start Date
July 29, 2024
Primary Completion Date
June 22, 2027
Study Completion Date
June 22, 2027
[68Ga]Ga-PSMA-11
\[68Ga\]Ga-PSMA-11 will be administered as a single intravenous dose of approximately 150 MBq (4 mCi) to be administered during baseline imaging and approximately 7 weeks after last RLT dose. Administered dose should not be lower than 111 MBq (3 mCi) or higher than 259 MBq (7 mCi)
[68Ga]GA-DOTA-TATE
\[68Ga\]Ga-DOTA-TATE will be administered as a single intravenous dose to be administered during baseline imaging and approximately 7 weeks after last RLT dose, within a range of 100-200MBq (2.7-5.4 mCi)
[68Ga]Ga-NeoB
\[68Ga\]Ga-NeoB will be administered as a single intravenous dose to be administered during baseline imaging and approximately 7 weeks after last RLT dose.within a range of 150-250 MBq (4.1-6.8 mCi).
[177Lu]Lu-PSMA-617
\[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for 6 cycles.
[177Lu]Lu-DOTA-TATE
\[177Lu\]Lu-DOTA-TATE will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%) every 6 weeks for 6 cycles.
[177Lu]Lu-NeoB
\[177Lu\]Lu-NeoB will be administered as an intravenous infusion at a dose of 9.25 GBq (250mCi) every 6 weeks for 6 cycles
L-Lysine HCl-L-Arginine HCl, 2.5 %,
sterile solution for infusion Lysine HCl-Arginine HCl, 2.5 % (1L)
Gonadotropin-releasing hormone (GnRH) analogues
Anatomical Therapeutic Chemical \[ATC\] code L02AE
GnRH antagonists
abarelix, degarelix, or relugolix
Antiemetics & antinauseants
ATC code A04A
Metoclopramide
ATC code A03FA01
RECRUITING
Memorial Sloan Kettering Cancer Ctr, New York
RECRUITING
Novartis Investigative Site, Madrid
RECRUITING
Novartis Investigative Site, Reggio Emilia
RECRUITING
Novartis Investigative Site, Nantes
RECRUITING
Novartis Investigative Site, Meldola
RECRUITING
Novartis Investigative Site, Lille
RECRUITING
Nebraska Cancer Specialists, Omaha
RECRUITING
Novartis Investigative Site, München
RECRUITING
Stanford University, Palo Alto
RECRUITING
Seattle Cancer Care Alliance, Seattle
RECRUITING
Novartis Investigative Site, L'Hospitalet de Llobregat
RECRUITING
Novartis Investigative Site, Sutton
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY