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NOT YET RECRUITING
NCT07441837
PHASE2

Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients

Sponsor: Ankara University

View on ClinicalTrials.gov

Summary

In this study it is aimed to analyze the efficacy and safety of Tb-161 PSMA I\&T in the 7.4 GBq activity in a large patient group of Lu-177 PSMA naïve mCRPC patients. 3 cycles of Tb-161 PSMA will be administered with 6 weeks periods. After each cycle a triple bed quantitative single photon emission CT (SPECT)-CT scan from vertex to thigh will be acquired 24 h after every treatment of Tb-161 PSMA. In the first cycle additional time points SPECT-CT acquisitions will be obtained for dosimetric calculations. Details of dosimetry acquisitions will be provided by dosimetry partner. Routine safety blood tests including full blood counts, liver function test, electrolytes, serum PSA, and assessment for adverse events were performed every 3 weeks during study treatment. Once the patient completed three cycles of Tb-161 PSMA, they will continue to undergo clinical review, assessment for adverse events, routine safety bloods, and PSA every 6 weeks for 48 weeks. OR to treatment will be assessed by Ga-68 PSMA PET/CT using RECIP 1.0 criteria.

Official title: Phase 2 Study of Terbium 161 PSMA in Lutetium-177 PSMA Naive mCRPC Patients

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-07-01

Completion Date

2028-09-01

Last Updated

2026-03-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Terbium 161- PSMA I&T

cycles of Tb-161 PSMA I\&T with 7.4 GBq activity

Locations (4)

Ankara University Medical School Dept of Nuclear Medicine

Ankara, Turkey (Türkiye)

Bilkent City Hospital

Ankara, Turkey (Türkiye)

Anadolu Sağlık Merkezi

Istanbul, Turkey (Türkiye)

Memorial Sisli Hospital

Istanbul, Turkey (Türkiye)