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Clinical Trials in Turkey / NCT07441837
Starting soon Phase 2

Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients

NCT07441837 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ankara University
Phase
Phase 2
Started
2026-07-01
Last updated
2026-06-10

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Terbium 161- PSMA I&T

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

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
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)

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Other trials for the same condition

Effect Of Trendelenburg Position And Pneumoperitoneum On Optic Nerve Sheath Diameter In Robot-Assisted Prostatectomy Recruiting
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC Active, not recruiting
Prostate Cancer Study of Patient Experiences Starting soon
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) Recruiting
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441837 on ClinicalTrials.gov ↗ ← All trials in Turkey