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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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