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Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients

NCT07441837 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Terbium 161- PSMA I&T

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

Sponsors & Collaborators

  • Oncosia Scientific GmbH

    collaborator INDUSTRY

  • EDH Nukleer Tip ve Saglik Hizmetleri Ltd. Sti.

    collaborator INDUSTRY

  • Ankara University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-08-01
Completion
2028-09-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441837 on ClinicalTrials.gov