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Radioisotope Therapy

Personalized PRRT for Neuroendocrine Tumors (P-PRRT Trial)

Phase 2

Waitlist Available

Led By Jean-Mathieu Beauregard, MD,MSc,FRCPC

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient suffering from a progressive and/or symptomatic NET (any site)

Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments

Must not have

Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of nadir blood counts values between 2 and 6 weeks after each cycle

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new way to give a cancer treatment called peptide receptor radionuclide therapy (PRRT). In this new way, the amount of PRRT given to each person will be different and personalized, based on how their body is expected to absorb the therapy. The goal is to maximize the amount of PRRT that gets to the tumor, while minimizing the amount that gets to healthy organs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include acute reactions like nausea, chronic conditions from radiation exposure to healthy tissues, and potential subacute effects that may appear after treatment. Severity will be monitored in relation to the radiation dose absorbed by organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neuroendocrine tumor is growing or causing symptoms.

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

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

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I am not eligible for or am refusing surgery that could potentially cure me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of nadir blood counts values between 2 and 6 weeks after each cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of nadir blood counts values between 2 and 6 weeks after each cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of nadir blood counts values between 2 and 6 weeks after each cycle for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Biochemical response

Progression-free survival (PFS)

Quality of life response

+1 more

Other study objectives

Bone marrow radiation dose-chronic toxicity relationship

Bone marrow radiation dose-subacute toxicity relationship

Renal radiation dose-chronic toxicity relationship

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 5Eligibility criteria met