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Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients
Sponsor: Ankara University
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
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)