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Clinical Trial NCT07441837 (TeLuNa) for Prostate Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients (TeLuNa) Phase 2 60

Not yet recruiting
Clinical Trial NCT07441837 (TeLuNa) is designed to study Treatment for Prostate Cancer. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 July 2026 until the study accrues 60 participants. Led by Ankara University, this study is expected to complete by 1 September 2028. The latest data from ClinicalTrials.gov was last updated on 11 March 2026.
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 a...Show More
Detailed Description
Radionuclide treatment with Lutetium-177 (Lu-177)-labelled prostate-specific membrane antigen (PSMA) has become a standard care of treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). Main advantages of Lu-177 PSMA improvement of overall survival and quality of life. Progression of disease occurs most of the patients after Lu-177 PSMA treatment. For this reason, labelling of PSMA with ...Show More
Official Title

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

Conditions
Prostate Cancer
Other Study IDs
  • TeLuNa
  • TeLuNa Trail
NCT ID Number
NCT07441837
Start Date (Actual)
2026-07-01
Last Update Posted
2026-03-11
Completion Date (Estimated)
2028-09-01
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Prostate cancer
terbium-166
radionuclide treatment
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTb-161 PSMA treatment arm
Patients who will treat with 3 cycles of Tb-161 PSMA with 7.4 GBq activity
Terbium 161- PSMA I&T
cycles of Tb-161 PSMA I\&T with 7.4 GBq activity
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective response evaluation
Response to treatment will be assessed by Ga-68 PSMA PET/CT using RECIP 1.0 criteria.
up to 6 weeks after last cycle of treatment (each cycle is 1 day)
PSA response evaluation
At least 50% change in the serum PSA levels
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)
Change in QoL
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.
within 1 months after each cycles (each cycle is 1 day)
Toxicity Evaluation
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
within three weeks after each treatment and with 6 weeks period within 6 to 48 weeks after last cycle (each cycle is 1 day)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Tumor absorbed dose calculations
To calculate the mean tumor absorbed doses in Gy with multi-frame SPECT/CT images with multi compartment model
within 96 hours after first cycle (each cycle is 1 day)
Organ absorbed dose calculations
To calculate the mean organ absorbed doses for salivary glands, kidney, liver and bone marrow in Gy with multi-frame SPECT/CT images
within 96 hours after first cycle (each cycle is 1 day)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • Men aged 18 years or older with mCRPC (histologically or cytologically confirmed adenocarcinoma of the prostate)
  • Progressive disease as defined by the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) under previous treatment with taxane chemotherapy (unless medically unsuitable) and at least one second-generation androgen receptor pathway inhibitor (ARPI)
  • Adequate bone marrow, hepatic, and renal function
  • Eastern Cooperative Oncology Group performance status of 0-2;
  • A life expectancy of at least 6 months.
  • On Ga-68 PSMA PET/CT, a maximum standardised uptake value (SUVmax) of at least 20 in at least one metastasis and SUVmax of at least 10 in measurable soft tissue metastases.
  • Patient has provided written informed consent
  • PSA progression: minimum of 2 rising PSA values from baseline measurement with interval of ≥1 wk between each measurement
  • Soft-tissue progression: per RECIST 1.1
  • Bone progression: ≥2 new lesions on bone scan
  • At least 3 wk interval since completion of surgery or radiotherapy before registration

  • Patients with discordant metastases defined as positive on 2-\[¹⁸F\]fluoro-2-deoxy-D-glucose (FDG) PET-CT with minimal uptake on Ga-68-PSMA PET-CT
  • Previous treatment with another radioisotope
  • Other malignancies within the previous 2 years before registration other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months
  • Concurrent illnesses that could jeopardise the ability of the patient to undergo the trial procedures.
  • Patient has symptomatic brain metastases or leptomeningeal metastases
  • Patient has symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for >4 wk
Ankara University logoAnkara University150 active studies to explore
  • Oncosia Scientific GmbH logoOncosia Scientific GmbH
  • EDH Nukleer Tip ve Saglik Hizmetleri Ltd. Sti. logoEDH Nukleer Tip ve Saglik Hizmetleri Ltd. Sti.
Study Responsible Party
Cigdem Soydal, Principal Investigator, Prof of Nuclear Medicine, Ankara University
Study Central Contact
Contact: Cigdem Soydal, Prof, +905333137701, [email protected]
4 Study Locations in 1 Countries
Ankara University Medical School Dept of Nuclear Medicine, Ankara, 06590, Turkey (Türkiye)
Cigdem Soydal, Prof, Contact, +905333137701, [email protected]
Cigdem Soydal, Prof, Principal Investigator
Mine Araz, Asc Prof, Sub-Investigator
Nuriye Ozlem Kucuk, Prof, Sub-Investigator
Yuksel Urun, Prof, Sub-Investigator
Bilkent City Hospital, Ankara, Turkey (Türkiye)
Elif Ozdemir, Prof, Contact, +905326841880, [email protected]
Elif Ozdemir, Prof, Principal Investigator
Anadolu Sağlık Merkezi, Istanbul, Turkey (Türkiye)
Kezban Berberoğlu, Contact, +905325846256, [email protected]
Kezban Berberoğlu, Sub-Investigator
Memorial Sisli Hospital, Istanbul, Turkey (Türkiye)
Cuneyt Turkmen, Prof, Contact, +905334942934, [email protected]
Cuneyt Turkmen, Prof, Principal Investigator