Personalized PRRT of Neuroendocrine Tumours

Official Title

Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumours: A Phase 2 Study

Summary:

In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumour, while limiting that to healthy organs. The purpose of this study is to: - Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT; - Assess the overall, the disease-specific, and the progression-free survival following P-PRRT; - Correlate therapeutic response and survival with tumour absorbed radiation dose; - Evaluate the acute, subacute and chronic adverse events following P-PRRT; - Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk; - Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research). This study also has a compassionate purpose, which is to provide access to PRRT to patients.

Trial Description

Primary Outcome:

• Objective response rate (ORR)

Secondary Outcome:

• Progression-free survival (PFS)
• Overall survival (OS)
• Symptomatic response rate
• Quality of life response
• Biochemical response
• Safety determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03

A prospective, single-centre, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumours (NET) of any origin expressing the somatostatin receptor. The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for the first 85 participants. This study as a compassionate aim to provide access to PRRT patients at CHU de Québec - Université Laval centre, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim. The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.

View this trial on ClinicalTrials.gov