NCT07441837Not yet recruitingPhase 2
Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients
Phase 2 Study of Terbium 161 PSMA in Lutetium-177 PSMA Naive mCRPC Patients
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Ankara University
- Diseases
- Prostate cancer
- NCT number
- NCT07441837
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Jul 2026 to the primary completion date, 1 Aug 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bilkent City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara University Medical School Dept of Nuclear Medicine Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Memorial Sisli Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Anadolu Sağlık Merkezi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.