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

Netherlands Cancer Institute (NKI)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Neuroendocrine Tumor Grade 2; Neuroendocrine Tumors; Neuroendocrine Neoplasm; Neuroendocrine Tumor Grade 1

Treatments: Drug: Somatostatin analog

Study type: Interventional

Funder types: Other

Identifiers

NCT06855095

N23PRR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: Somatostatin analog

2B - LA-SSA injection 1-7 days before PRRT

Experimental group

Description:

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.

Treatment:

Drug: Somatostatin analog