Peptide Receptor Radionuclide Therapy (PRRT)

What is PRRT and how does it work?

Peptide Receptor Radionuclide Therapy (PRRT) uses a radiolabelled somatostatin analog that binds to receptors on tumour cells, combined with radioactive compounds, including 111Indium, 68Galiium, 90Yttrium, 177Lutetium, to deliver the killing effect of the radioactivity directly to the cell, avoiding destruction of healthy cells often found with external beam radiation.

Lutetium Lu 177 dotatate (Lutathera)

LUTATHERA® (lutetium Lu 177 dotatate) – PRODUCT MONOGRAPH
Brand Name Lutathera
Generic Name Lutetium Lu 177 dotatate
Strength 370 MBq/mL
Indication Lutathera® (lutetium (177Lu) oxodotreotide) was approved by Health Canada in January  2019, for the treatment of unresectable (not removable by surgery) or metastatic, well-differentiated, somatostatin receptor-positive (expressing the somatostatin receptor) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults with progressive disease.
Tumour Type Gastrointestinal
Contraindications
  • Severe renal impairment (creatinine clearance < 30 mL/min)
  • Established or suspected pregnancy (when pregnancy has not been excluded)
  • Hypersensitivity to the active substance or to any of the excipients listed

The pCODR Expert Review Committee  Final Recommendation was issued on August 01, 2019  – Reimburse with clinical criteria and/or conditions* for treatment of adult patients with somatostatin receptor positive ( SSR+) midgut neuroendocrine tumours (NETs ) whose disease has progressed on a somatostatin analogue and is unresectable ( see conditions )

pERC Final Recommendation

The INESSS  recommendation was issued February 2019Funded as a Médicament d’exception for neuroendocrine tumours in the digestif tract or pancreatic well differentiated, advanced disease, non resectable or metastatic expressing the somatostatin receptor in adults. ( see conditions )

Access to LUTATHERA in Canada

FUNDED

As of August 1, 2020, patients with midgut, GEP-NETs will now be eligible for treatment with LUTATHERA® [lutetium (177Lu) oxodotreotide]. This listing covers adult patients with somatostatin receptor-positive (SSR+) midgut NETs whose disease has progressed on a somatostatin analogue and is unresectable (not removable by surgery).

The Ontario funding criteria covers the treatment of adult patients with somatostatin receptor-positive (SSR+) midgut NETs whose disease has progressed on a somatostatin analogue and is unresectable (not treatable by surgery). Eligible patients include those with progressed SSR+ midgut (defined as jejunoileum and proximal in the NETTER-1 trial) NETs and good performance status.

AAA press release:
ENGLISH – can be viewed at http://www.newswire.ca/en/releases/archive/October2020/08/c9204.html
FRENCH – can be viewed at http://www.newswire.ca/fr/releases/archive/October2020/08/c5664.html

As of September 30, 2020, the Québec Ministry of Health and Social Services has listed Lutathera on the Liste de Médicaments – Établissements. Lutathera will be reimbursed for GEP-NETs patients with advanced disease that is metastatic or not removable by surgery and has progressed despite standard somatostatin analogue therapy and whose ECOG (Eastern Clinical Oncology Group) score is 0 to 2. Please refer to the following link for the formulary listing: https://www.ramq.gouv.qc.ca/sites/default/files/documents/liste-med-etab-2020-09-30-fr.pdf

Please see the press release:

ENGLISH –can be viewed at http://www.newswire.ca/en/releases/archive/October2020/01/c7837.html
FRENCH –can be viewed at http://www.newswire.ca/fr/releases/archive/October2020/01/c9369.html

New LUTATHERA Website Launched

Advanced Accelerator Applications Canada, Inc. has launched an English and French website for patients and healthcare professionals to provide information on treatment with Lutathera.  

Please visit: www.lutathera.ca

To get the Lutathera DIN, click on the attached Link: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

Enter Lutathera under product name.

NETTER-1 Study

NETTER-1 Study –  Unmet need for long-term effective treatment of inoperable, gastro-entero-pancreatic neuroendocrine tumours (GEPNET).

This first Phase III trial compares 177Lu-DOTATATE with Octreotide (Sandostatin® LAR Depot) in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumours. 230 patients are divided into two groups of 115 each. The primary objective is to compare Progression Free Survival (PFS) between the groups. Secondary objectives are to compare Objective Response Rate, Overall Survival (OS), Time to Tumour Progression between groups, and to assess safety, tolerability and quality of life. 35 European and 15 U.S. sites are involved.

See trial details at: NETTER-1 STUDY

Key Facts about PRRT

PRRT Trials In Canada

Personalized PRRT of Neuroendocrine Tumors Drug: 177Lu Octreotate CHU de Québec – Université Laval
Quebec City, Quebec, Canada
An Open Label Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours Other: Lu-DOTA-TATE London Health Sciences Centre
London, Ontario, Canada
A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours Drug: [177]Lu-DOTA-TATE Cross Cancer Institute
Edmonton, Alberta, Canada
Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors Drug: Lutetium-177 Octreotate Juravinski Cancer Centre
Hamilton, Ontario, CanadaLondon Health Sciences Centre
London, Ontario, CanadaPrincess Margaret Cancer Centre
Toronto, Ontario, CanadaSunnybrook Odette Cancer Center
Toronto, Ontario, Canada

Advanced Accelerator Applications, AAA, has a new website regarding PRRT with Lutathera for both patients and providershttps://lutathera.com/. This website is intended for US residents only, there is a separate link for Non-US residents.  There is also a separate section within the site for Healthcare Providers.

PRRT Webinar

Peptide Receptor RadioTherapy for Neuroendocrine Tumours

Third Theranostic World Congress – Patient Edition
For full videos from the 3rd Theranostic World Congress that might be of more interest to NET Patients

Peptide Receptor Radionuclide Therapy in Neuroendocrine Tumors

Published on Apr 6, 2016
The panelists, Matthew H. Kulke, MD; Eric H. Liu, MD, FACS; and James C. Yao, MD, discuss the potential value of peptide receptor radionuclide therapy in treating neuroendocrine tumors.