Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial

NCT06855095 — Phase 2 / Phase 3, Recruiting, 39 participants, The Netherlands Cancer Institute

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Registry	NCT06855095, acronym ATSA
Status	Recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	39 (Estimated)
Sponsor	The Netherlands Cancer Institute (Other); collaborators: Neuroendocrine Tumor Research Foundation
Conditions	Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Neoplasm
Interventions	Somatostatin analog (Drug)
Dates	start 2024-06-25, primary completion 2027-01-01 (estimated), completion 2027-03-01 (estimated), first posted 2025-03-03, last updated 2025-03-03
Locations	1 site in Netherlands

-Summary

According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.

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+Detailed description

The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.

+Arms and interventions

Arm	Type	Interventions	Description
Control	No intervention		In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included.
2A - LA-SSA injection 4-6 weeks before PRRT	Active comparator	Drug: Somatostatin analog	In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.
2B - LA-SSA injection 1-7 days before PRRT	Experimental	Drug: Somatostatin analog	In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.

Somatostatin analog (Drug): Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).

+Outcome measures

Primary outcomes

Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT. [SPECT/CT after 4h, 24h, and 5-7 days post-injection]

Secondary outcomes

Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT. [SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection]
Effect of continued LA-SSA use on the tumor-to-background ratio. [SPECT/CT after 4h, 24h, and 5-7 days post-injection]
Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE. [Blood samples at 2h, 4h, 24h and 5-7 days post-injection]

Other outcomes

HRQoL assessments [At baseline, on the day of PRRT administration, 3 weeks after PRRT]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥ 18 years;
* Able to provide spoken and written informed consent for the trial;
* Histopathological confirmed neuroendocrine tumor;
* Fulfill the clinical criteria for PRRT;
* At least one soft tissue lesion > 2 cm;
* Aimed administered activity of 7400 MBq;
* ECOG score (performance status) 0-2.

Exclusion Criteria:

* Not possible to discontinue LA-SSA for 4-6 weeks;
* Use of short-acting SSAs;
* Pregnancy and lactating female patients;
* Inability to comply to the study procedures;
* Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).

+Locations (1)

Facility	City	Country	Status
Antoni van Leeuwenhoek	Amsterdam	Netherlands	Recruiting