Clinical trial · Interventional
PSMA Expression and PSMA PET Imaging in Soft Tissue Sarcomas and Urothelial Cell Carcinomas
Expression of Prostate Specific Membrane Antigen (PSMA) in Soft Tissue Sarcomas and Urothelial Cell Carcinomas: Implications for Tumour-specific Molecular Imaging and Treatment?
- 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)
This pilot study aims to investigate the PSMA expression in the biopsy material of advanced soft tissue sarcomas and advanced urothelial cell carcinomas, and in case of high PSMA expression (as defined by previous literature), to investigate whether this correlates with high tracer uptake on PSMA-targeted PET. This way, (a subset of) patients can be selected that could benefit from radionuclide targeted therapy in the future.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma,Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-JK-PSMA-7 PET/CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Advanced soft tissue sarcoma (n=60) and advanced urothelial cell carcinoma (n=60)
- description
- The study population comprises sixty adult patients with diagnosis of advanced (locally irresectable or metastasized) soft tissue sarcoma (cohort 1) and sixty adult patients with diagnosis of advanced (muscle invasive or metastasized) urothelial cell carcinoma (cohort 2).
- interventionNames
- Diagnostic Test: [18F]-JK-PSMA-7 PET/CT scan
Primary outcomes (1)
- measure
- Quantify PSMA-tracer accumulation and determine whether SUV > 8
- timeFrame
- 6 months
- description
- To quantify the accumulation of \[18F\]-JK-PSMA-7 on PET/CT imaging by using the standardized uptake values (SUV) and to determine the number of patients in which the SUVmax in advanced soft tissue sarcoma (cohort 1) and advanced urothelial cell carcinoma (cohort 2) is higher than 8. In these patients, PSMA-targeted radioligand therapy might be beneficial in the future.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years at the time of informed consent. * Diagnosis of advanced (locally irresectable or metastasized) soft tissue sarcoma (cohort 1) or advanced (muscle invasive or metastasized) urothelial cell carcinoma (cohort 2). * Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol. * Recent (\< 8 weeks) standard imaging (with CT or \[18F\]-FDG PET/CT) with measurable disease (lesion diameter \> 1 cm). * Biopsy available of primary tumour and/or metastasis * WHO performance status of 0-2 * Either: * No previous systemic therapy for advanced soft tissue sarcoma or advanced urothelial cell carcinoma, or; * Previous systemic therapy for advanced soft tissue sarcoma or advanced urothelial cell carcinoma with progression of disease during systemic therapy or progression of disease after discontinuation of systemic therapy, or; * Previous systemic therapy for advanced soft tissue sarcoma or advanced urothelial cell carcinoma with partial response or stable disease, where the last dose of systemic therapy was given \> 8 weeks before. Exclusion Criteria: * Women who are pregnant and/or lactating. * Medical or psychiatric conditions that compromise the patient's ability to give informed consent. * Known hypersensitivity to drugs comparative to \[18F\]-JK-PSMA-7, any of their excipients or to any component of \[18F\]-JK-PSMA-7. * Inability to undergo PET/CT scanning, e.g. claustrophobia, weight limits or inability to tolerate lying down for the duration of a PET/CT scan (\~30 minutes).
References
Publications (1)
- DERIVEDKleiburg F, van der Hulle T, Gelderblom H, Slingerland M, Speetjens FM, Hawinkels LJAC, Dibbets-Schneider P, van Velden FHP, Pool M, Lam SW, Bovee JVMG, Heijmen L, de Geus-Oei LF. PSMA expression and PSMA PET/CT imaging in metastatic soft tissue sarcoma patients, results of a prospective study. Eur J Nucl Med Mol Imaging. 2025 Aug;52(10):3690-3699. doi: 10.1007/s00259-025-07224-z. Epub 2025 Mar 27. PMID 40146266