Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients
Turkey (Türkiye)60 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 illness…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response evaluation
Timeframe: up to 6 weeks after last cycle of treatment (each cycle is 1 day)
2
PSA response evaluation
Timeframe: 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)
3
Change in QoL
Timeframe: within 1 months after each cycles (each cycle is 1 day)
4
Toxicity Evaluation
Timeframe: within three weeks after each treatment and with 6 weeks period within 6 to 48 weeks after last cycle (each cycle is 1 day)