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Observational prospective cohort (n=50, recruiting)ClinicalTrials.govClinicalTrials.gov

Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

Methodist Health System Research Team

NCT04090034 ↗

Summary

This ongoing observational study at Methodist Health System is collecting real-world data on treatment responses, survival outcomes, and adverse events in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients treated with peptide receptor radionuclide therapy (PRRT). The study tracks patients for up to 7 years post-procedure.

Clinical Significance

As PRRT with ¹⁷⁷Lu-DOTATATE becomes increasingly adopted for neuroendocrine tumors, real-world outcome data beyond clinical trials is essential. This registry will help optimize patient selection and identify predictors of response to peptide-based radioligand therapy.

Trial Details

  • Design: Prospective observational cohort
  • Population: GEP-NET patients with metastatic/locally advanced inoperable disease
  • Inclusion criteria: Ki67 <20%, DOTATATE PET-positive, progressive disease on octreotide
  • Primary outcomes: Demographics, tumor data, biomarkers (chromogranin A, pancreastatin), imaging response, OS, TTP
  • Follow-up: Up to 7 years from first PRRT
  • Status: Actively recruiting, estimated completion June 2026

Clinical Implications

PRRT is a key treatment modality for well-differentiated GEP-NETs. This real-world registry will complement the landmark NETTER-1 trial data by providing long-term outcomes in a broader patient population treated in community oncology settings.

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