Expression of prostate specific membrane antigen (PSMA) in soft tissue sarcomas and urothelial cell carcinomas: implications for tumour-specific molecular imaging and treatment?

Expression of prostate specific membrane antigen (PSMA) in soft tissue sarcomas and urothelial cell carcinomas: implications for tumour-specific molecular imaging and treatment? - PSMA expression & PSMA PET in soft tissue sarcoma/urothelial cell carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54064

Enrollment

120

Registered

2022-04-11

Start date

2022-08-11

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer cohort 1: soft tissue cancer cohort 2: transitional cell carcinoma soft tissue tumour

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 ( 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

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).

Design outcomes

Primary

Measure	Time frame
The correlation between the level of PSMA expression in biopsy material and the level of PSMA tracer uptake on [18F]-JK-PSMA-7 PET/CT in advanced soft tissue sarcomas (cohort 1) and advanced urothelial cell carcinomas (cohort 2).	—

Secondary

Measure	Time frame
The correlation between the level of PSMA expression in biopsy material and tumour grade, tumour stage and tumour type. Quantification of the accumulation of [18F]-JK-PSMA-7 on PET/CT imaging by using SUV. In case of metastasized disease, the differences in the level and heterogeneity of PSMA expression (if biopsy material is available) and PSMA tracer uptake on [18F]-JK-PSMA-7 PET/CT between primary tumours and metastases. The agreement between [18F]-JK-PSMA-7 PET/CT and standard imaging (CT or [18F]-FDG PET/CT).	—

Measure

Time frame

The correlation between the level of PSMA expression in biopsy material and tumour grade, tumour stage and tumour type. Quantification of the accumulation of [18F]-JK-PSMA-7 on PET/CT imaging by using SUV. In case of metastasized disease, the differences in the level and heterogeneity of PSMA expression (if biopsy material is available) and PSMA tracer uptake on [18F]-JK-PSMA-7 PET/CT between primary tumours and metastases. The agreement between [18F]-JK-PSMA-7 PET/CT and standard imaging (CT or [18F]-FDG PET/CT).

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Countries

Netherlands

Outcome results