Clinical trial · Observational
A Retrospective Data Analysis of Therapy With PRRT Combined With Lanreotide Autogel® for Neuroendocrine Tumours
Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Lanreotide Autogel: A Retrospective Study in Progressive Digestive and Bronchopulmonary Neuroendocrine Neuroendocrine Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study terminated prematurely due to insufficient recruitment.
Summary
Brief summary (as posted)
The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG) combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive neuroendocrine tumours located in the lung or in the digestive system as there is currently limited data on these treatments used together for these types of neuroendocrine tumours.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumours | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1)
- timeFrame
- Approximately 3 to 6 months after the last PRRT/LAN ATG cycle
Secondary outcomes (8)
- measure
- PFS rate as per RECIST (Version 1.1)
- timeFrame
- Up to 12 months post-treatment
- measure
- Best Overall Response as per RECIST (Version 1.1)
- timeFrame
- Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier
- measure
- Objective Response Rate as per RECIST (Version 1.1)
- timeFrame
- Approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed metastatic well differentiated Neuroendocrine Tumour (NET) (Grade G1 or G2 according to the World Health Organisation 2010 classification): Gastro-entero-pancreatic (GEP) or Bronchopulmonary (BP) primary tumour, or tumour of unknown origin believed to be of GEP origin, if a primary tumour elsewhere was excluded by multiphasic computerised tomography (CT) or magnetic resonance imaging (MRI) * Disease progression radiologically documented with evaluable imaging (CT or MRI, digital or print-out), performed within 12 months and within 6 months prior to the first PRRT/LAN ATG cycle * Metastatic- or locally-advanced, hormonal functioning or nonfunctioning GEP-NET or BP-NET; * Confirmed presence of Somatostatin Receptors (SSTRs) on all target lesions based on positive SSTR scintigraphy (Octreoscan®/99mTC-tektrotyd) or 68Ga SSTR Positron Emission Tomography-Computerised Tomography (PET/CT) imaging, i.e. Grade ≥2 respectively per the Krenning scale or per the modified Krenning scale Exclusion Criteria: * Absence of information regarding LAN ATG treatment: dose received, start date, frequency of injections * No CT or MRI within 12 months and within 6 months preceding the baseline, or at the end of the last PRRT/LAN ATG cycle * Absence of information on cumulative activity of PRRT with 177 Lutetium (177Lu) DOTATOC or 177Lu-DOTATATE received (at least 500 mCi (equivalent to 18.5 GBq), for the entire therapy) * PRRT prior to the first combination cycle of PRRT/LAN ATG
References
Publications (1)
- DERIVEDPrasad V, Srirajaskanthan R, Toumpanakis C, Grana CM, Baldari S, Shah T, Lamarca A, Courbon F, Scheidhauer K, Baudin E, Truong Thanh XM, Houchard A, Dromain C, Bodei L. Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: a need for standardised practice. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2358-2371. doi: 10.1007/s00259-020-04712-2. Epub 2020 Feb 15. PMID 32062681