drugset / Trial / NCT06379217
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
Non-randomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2024-07-29
- Primary completion
- 2026-09-11
- Completion
- 2026-09-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [177Lu]Lu-DOTA-TATE | Other / unclassified | 7.4 g | Intravenous |
| Subject | [177Lu]Lu-NeoB | Other / unclassified | 9.25 g | Intravenous |
| Subject | [177Lu]Lu-PSMA-617 | Other / unclassified | 7.4 g | Intravenous |
| Subject | [68Ga]Ga-DOTA-TATE | Diagnostic / imaging agent | 100 mbq | Intravenous |
| Subject | [68Ga]Ga-DOTA-TATE | Diagnostic / imaging agent | 200 mbq | Intravenous |
| Subject | [68Ga]Ga-NeoB | Diagnostic / imaging agent | 150 mbq | Intravenous |
| Subject | [68Ga]Ga-NeoB | Diagnostic / imaging agent | 250 mbq | Intravenous |
| Subject | [68Ga]Ga-PSMA-11 | Diagnostic / imaging agent | 150 mbq | Intravenous |
| Background | Degarelix | Other / unclassified | — | — |
| Background | L-Lysine HCl-L-Arginine HCl | Unknown | 2.5 % | Other |
| Background | Metoclopramide | Small molecule | — | — |
| Background | Relugolix | Small molecule | — | — |
| Background | abarelix | Protein / enzyme biologic | — | — |