NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 29, 2024

Primary Completion Date

June 22, 2027

Study Completion Date

June 22, 2027

Conditions
Metastatic Neuroendocrine Prostate Cancer
Interventions
DRUG

[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)

DRUG

[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)

DRUG

[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).

DRUG

[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.

DRUG

[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.

DRUG

[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

DRUG

L-Lysine HCl-L-Arginine HCl, 2.5 %,

sterile solution for infusion Lysine HCl-Arginine HCl, 2.5 % (1L)

DRUG

Gonadotropin-releasing hormone (GnRH) analogues

Anatomical Therapeutic Chemical \[ATC\] code L02AE

DRUG

GnRH antagonists

abarelix, degarelix, or relugolix

DRUG

Antiemetics & antinauseants

ATC code A04A

DRUG

Metoclopramide

ATC code A03FA01

Trial Locations (12)

10017

RECRUITING

Memorial Sloan Kettering Cancer Ctr, New York

28041

RECRUITING

Novartis Investigative Site, Madrid

42123

RECRUITING

Novartis Investigative Site, Reggio Emilia

44093

RECRUITING

Novartis Investigative Site, Nantes

47014

RECRUITING

Novartis Investigative Site, Meldola

59037

RECRUITING

Novartis Investigative Site, Lille

68130

RECRUITING

Nebraska Cancer Specialists, Omaha

80377

RECRUITING

Novartis Investigative Site, München

94304

RECRUITING

Stanford University, Palo Alto

98109

RECRUITING

Seattle Cancer Care Alliance, Seattle

08907

RECRUITING

Novartis Investigative Site, L'Hospitalet de Llobregat

SM2 5PT

RECRUITING

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY