Clinical trial · Observational
Performance of 177Lu-PSMA-I&T for RLT in mCRPC - Prospective Multicenter Swiss Registry Study
Swiss Cancer Registry on Safety and Efficacy of 177Lu-ITG-PSMA-1 Radionuclide Therapy in Prostate Cancer 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)
The goal of this observational study (multicenter, national registry-based) is to evaluate the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I\&T) as therapy in patients with metastatic castration resistent prostate cancer (mCRPC). The main questions are whether the 177Lu-PSMA-I\&T is safe and if it works well to treat patients with progressive mCRPC. The data and information in the study are collected under standard medical therapy and follow-up, so called real-world conditions. Participants will: * undergo regular radioligand therapy (RLT) with 177Lu-PSMA-I\&T * have clinical, laboratory and imaging follow-up according to the currently available recommendation for PSMA-RLT an in line with their medical needs. * answer study related set of questionnaires
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 |
|---|---|---|---|
| mCRPC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radionuclide therapy with 177Lu-PSMA-I&T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patient wit progressive mCRPC
- interventionNames
- Drug: radionuclide therapy with 177Lu-PSMA-I&T
Primary outcomes (1)
- measure
- Frequency and severity of treatment related adverse event
- timeFrame
- performed at baseline (before starting the first therapy cycle), during (before each additional therapy cycle) and at 8-14 weeks after completion of all therapy cycles
- description
- frequency and severity of treatment related adverse events evaluated on standard blood tests (CBC, liver and kidney function)-, according to CTCAE 5.0
Secondary outcomes (5)
- measure
- Efficacy - biochemical response
- timeFrame
- performed at baseline (before starting the first therapy cycle), during (before each additional therapy cycle) and at 8-14 weeks after completion of all therapy cycles
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * hormone-refractory and PSMA PET/CT-positive prostate tumors * progressed after or are ineligible for chemotherapy, next-generation antihormonal therapy or bone-directed radiation therapy -- male patients with an age above 18 years Exclusion Criteria: * patients who are not eligible for PSMA RLT, according to current, standard medical indications and guidelines * patients who for medical or non-medical reasons are unable to give their consent * patients withdrawing their consent for participation (NB: the already collected data in such cases will be anonymized and further used for applicable analyses)
References
Publications (0)
Data not yet available