Personalized PRRT for Neuroendocrine Tumors
(P-PRRT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJean-Mathieu Beauregard, MD,MSc,FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: CHU de Quebec-Universite Laval

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 tumor, 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 tumor 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.

Eligibility Criteria

This trial is for patients with neuroendocrine tumors showing high levels of a specific receptor, who can't have or don't want surgery and haven't had success with other treatments. It's not for those with very short life expectancy, severe illness (ECOG 4), or pregnant/breastfeeding individuals.

Inclusion Criteria

My neuroendocrine tumor is growing or causing symptoms.

I cannot or do not want to use other available treatments for my condition.

My tumor shows high levels of a specific protein, confirmed by a special scan.

+1 more

Exclusion Criteria

My doctors expect I have only a few weeks to live due to my condition.

Pregnancy

Breastfeeding

+1 more

Participant Groups

The study tests personalized doses of a radioactive drug called LuTate to treat neuroendocrine tumors effectively while minimizing harm to healthy organs. The goal is to improve survival rates and understand the relationship between radiation dose received by the tumor and patient outcomes.

1Treatment groups

Experimental Treatment

Group I: Personalized PRRT (P-PRRT)Experimental Treatment1 Intervention

177Lu-Octreotate (LuTate) P-PRRT will be administered as follows: * Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles. * The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s). * Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles. * Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s).