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Studies

Interventional Not yet recruiting Phase 2

NCT07441837 on ClinicalTrials.gov

Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients

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

  • Sponsor: Ankara University
  • Collaborators: Oncosia Scientific GmbH, EDH Nukleer Tip ve Saglik Hizmetleri Ltd. Sti.
  • Enrollment: 60 (Estimated)
  • Study start: 2026-07-01 (Estimated)
  • Primary completion: 2028-08-01 (Estimated)
  • Study completion: 2028-09-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: Single arm of prostate cancer patients who are naive for radionuclide treatments
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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

  • Prostate Cancer

Intervention / Treatment

  • Drug: Terbium 161- PSMA I&T

Primary Outcome Measures

  • Objective response evaluation (up to 6 weeks after last cycle of treatment (each cycle is 1 day))
    Response to treatment will be assessed by Ga-68 PSMA PET/CT using RECIP 1.0 criteria.
  • PSA response evaluation (within three weeks after each treatment cycle and with 6 weeks periods from 6 to 48 weeks after last cycle (each cycle is 1 day))
    At least 50% change in the serum PSA levels
  • Change in QoL (within 1 months after each cycles (each cycle is 1 day))
    Change in QoL will be evaluated by change in scores of the Functional Assessment of Cancer Therapy for Prostate (FACTP) questionnaire for treatment-specific symptoms.
  • Toxicity Evaluation (within three weeks after each treatment and with 6 weeks period within 6 to 48 weeks after last cycle (each cycle is 1 day))
    To analyze the organ toxicities of Tb-161 PSMA treatment with 7.4 GBq activity in 3 cycles with Common Terminology Criteria for Adverse Events (CTCAE) scores

Countries

Turkey (Türkiye)

Locations and Investigators

  • Ankara University Medical School Dept of Nuclear Medicine, Ankara, Turkey (Türkiye)
    • Cigdem Soydal, Prof
    • Cigdem Soydal, Prof (Principal Investigator)
    • Mine Araz, Asc Prof
    • Nuriye Ozlem Kucuk, Prof
    • Yuksel Urun, Prof
  • Bilkent City Hospital, Ankara, Turkey (Türkiye)
    • Elif Ozdemir, Prof
    • Elif Ozdemir, Prof (Principal Investigator)
  • Anadolu Sağlık Merkezi, Istanbul, Turkey (Türkiye)
    • Kezban Berberoğlu
    • Kezban Berberoğlu
  • Memorial Sisli Hospital, Istanbul, Turkey (Türkiye)
    • Cuneyt Turkmen, Prof
    • Cuneyt Turkmen, Prof (Principal Investigator)