Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients

NCT07441837 | Not Yet Recruiting Phase 2

• 1 other identifier: TeLuNa Trail
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Keywords

Prostate cancer; terbium-166; radionuclide treatment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Tumor absorbed dose calculations

  within 96 hours after first cycle (each cycle is 1 day)

• Organ absorbed dose calculations

  within 96 hours after first cycle (each cycle is 1 day)

Study Arms (1)

Tb-161 PSMA treatment arm

EXPERIMENTAL

Patients who will treat with 3 cycles of Tb-161 PSMA with 7.4 GBq activity

Drug: Terbium 161- PSMA I&T

Interventions

Terbium 161- PSMA I&T DRUG

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

Tb-161 PSMA treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead
• Oncosia Scientific GmbH: collaborator
• EDH Nukleer Tip ve Saglik Hizmetleri Ltd. Sti.: collaborator

Study Sites (4)

Ankara University Medical School Dept of Nuclear Medicine

Ankara, 06590, Turkey (Türkiye)

Location

Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Anadolu Sağlık Merkezi

Istanbul, Turkey (Türkiye)

Location

Memorial Sisli Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Cigdem Soydal, Prof

CONTACT

+905333137701; csoydal@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Nuclear Medicine

Model Details: Single arm of prostate cancer patients who are naive for radionuclide treatments

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-02

Locations

TU (4)