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NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the baseline and following targeted radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC). Study is planning to enroll approximately 20 participants in \[177Lu\]Lu-PSMA-617 treatment arm, approximately 3 participants in \[177Lu\]Lu-NeoB treatment arm, and approximately 13 participants in \[177Lu\]Lu-DOTA-TATE treatment arm.
Official title: A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
Key Details
Gender
MALE
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2024-07-29
Completion Date
2026-08-27
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
[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 at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. 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 at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. 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 at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. 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
Locations (11)
Stanford University
Palo Alto, California, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Rostock, Germany
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Sutton, Surrey, United Kingdom
Novartis Investigative Site
London, United Kingdom