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Radioisotope Therapy
Personalized PRRT for Neuroendocrine Tumors (P-PRRT Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of nadir blood counts values between 2 and 6 weeks after each cycle
Awards & highlights
P-PRRT Trial 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.Check my eligibility
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.See study design
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.
P-PRRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My neuroendocrine tumor is growing or causing symptoms.
Select...
I cannot or do not want to use other available treatments for my condition.
Select...
My tumor shows high levels of a specific protein, confirmed by a special scan.
Select...
I am not eligible for or am refusing surgery that could potentially cure me.
P-PRRT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Biochemical response
Overall survival (OS)
Progression-free survival (PFS)
+3 moreOther outcome measures
Bone marrow radiation dose-chronic toxicity relationship
Bone marrow radiation dose-subacute toxicity relationship
Renal radiation dose-chronic toxicity relationship
+2 moreSide effects data
From 2021 Phase 3 trial • 231 Patients • NCT0157823927%
Fatigue
19%
Abdominal pain
18%
Diarrhoea
13%
Abdominal distension
12%
Nausea
11%
Decreased appetite
10%
Arthralgia
10%
Back pain
9%
Hyperglycaemia
9%
Hypokalaemia
9%
Flushing
9%
Oedema peripheral
9%
Dizziness
8%
Dyspnoea
8%
Vomiting
8%
Gamma-glutamyltransferase increased
7%
Hypertension
7%
Weight decreased
7%
Aspartate aminotransferase increased
7%
Insomnia
7%
Anaemia
7%
Blood alkaline phosphatase increased
7%
Cough
7%
Asthenia
6%
Urinary tract infection
6%
Alanine aminotransferase increased
6%
Dyspepsia
5%
Anxiety
5%
Palpitations
5%
Constipation
5%
Flatulence
5%
Blood creatinine increased
5%
Musculoskeletal pain
5%
Pain in extremity
5%
Headache
4%
Hyponatraemia
4%
Malignant neoplasm progression
4%
Influenza like illness
3%
Haematuria
3%
Pyrexia
3%
Blood bilirubin increased
2%
Syncope
2%
Lymphocyte count decreased
2%
Platelet count decreased
2%
Abdominal pain lower
2%
General physical health deterioration
2%
Abdominal pain upper
2%
Alopecia
2%
Small intestinal obstruction
2%
Muscle spasms
2%
Dysgeusia
1%
Neoplasm progression
1%
White blood cell count decreased
1%
Breast cancer stage I
1%
Thrombotic cerebral infarction
1%
Carcinoid crisis
1%
Non-small cell lung cancer
1%
Hyperuricaemia
1%
Haemorrhage intracranial
1%
Pleural effusion
1%
Arteriospasm coronary
1%
Cardiac failure congestive
1%
Duodenal obstruction
1%
Gastrointestinal obstruction
1%
Ileus
1%
Impaired gastric emptying
1%
Generalised oedema
1%
Limb injury
1%
Muscular weakness
1%
Prostate cancer
1%
Transient global amnesia
1%
Acute kidney injury
1%
Renal impairment
1%
Cholecystitis acute
1%
Anal haemorrhage
1%
Ascites
1%
Dehydration
1%
Basal cell carcinoma
1%
Malignant bowel obstruction
1%
Oesophagitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide LAR
177Lu-DOTA0-Tyr3-Octreotate
P-PRRT 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).
Find a Location
Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
106,857 Total Patients Enrolled
Jean-Mathieu Beauregard, MD,MSc,FRCPCPrincipal InvestigatorCHU de Québec - Université Laval
1 Previous Clinical Trials
500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My neuroendocrine tumor is growing or causing symptoms.My doctors expect I have only a few weeks to live due to my condition.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.I am not eligible for or am refusing surgery that could potentially cure me.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized PRRT (P-PRRT)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree does 177Lu-Octreotate endanger patients?
"While there is some clinical data supporting the safety of 177Lu-Octreotate, it has not been proven effective yet in any trials. Therefore, it receives a score of 2."
Answered by AI
Are there any inclusions or exclusions for participants in this research?
"The listed information on clinicaltrials.gov affirms that this study is actively seeking participants. This trial was first posted 4/12/2016, with 300 patients needed from 1 site, and was most recently edited 7/15/2020."
Answered by AI
What are the past findings of 177Lu-Octreotate?
"There are 23 ongoing clinical trials and 1 in Phase 3 for 177Lu-Octreotate. Most of these studies originated in Iowa City, but there are now 162 research sites total across the globe."
Answered by AI
What is the headcount for this research project?
"Yes, that is correct. The clinicaltrials.gov website lists this study as actively recruiting patients. This trial was first posted on April 12th, 2016 and was last updated on July 15th, 2020. They are looking for 300 patients from 1 site to participate."
Answered by AI
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