A Multicenter Retrospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) Using 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN)

A Multicenter Retrospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) Using 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN) - R-PRRT retrospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058068

Enrollment

Registered

2025-06-03

Start date

2024-12-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Neoplasms

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who meet all of the following criteria will be included in the study: 1. Histologically confirmed diagnosis of neuroendocrine neoplasm (NEN). 2. Presence of unresectable and/or recurrent NEN. 3. Completion of four cycles of initial peptide receptor radionuclide therapy (I-PRRT) with 177Lu-DOTATATE. 4. Receipt of at least one cycle of retreatment PRRT (R-PRRT) with 177Lu-DOTATATE by March 31, 2025.

Exclusion criteria

Exclusion criteria: 1. Those who have received either initial PRRT (I-PRRT) or retreatment PRRT (R-PRRT) abroad, even once. 2. Those whom the attending physician deems inappropriate for inclusion in this study.

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR)	—

Secondary

Measure	Time frame
progression-free survival (PFS); disease control rate (DCR); objective response rate (ORR) by primary tumor site; disease control rate (DCR) by primary tumor site; the interval from the last administration of initial PRRT (I-PRRT) to the initiation of retreatment PRRT (R-PRRT); incidence of major hematologic toxicities; incidence of nephrotoxicity; and incidence of other adverse events.	—

Countries

Japan

Contacts

Public ContactYasuhiro Komori

National Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology

yakomor@ncc.go.jp+81-3-3542-2511

Outcome results