Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Terbium 161- PSMA I&T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tb-161 PSMA treatment arm
- description
- Patients who will treat with 3 cycles of Tb-161 PSMA with 7.4 GBq activity
- interventionNames
- Drug: Terbium 161- PSMA I&T
Primary outcomes (4)
- measure
- Objective response evaluation
- timeFrame
- up to 6 weeks after last cycle of treatment (each cycle is 1 day)
- description
- Response to treatment will be assessed by Ga-68 PSMA PET/CT using RECIP 1.0 criteria.
- measure
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available