PSMA Expression and PSMA PET Imaging in Soft Tissue Sarcomas and Urothelial Cell Carcinomas

NCT05522257 | Completed

• 1 other identifier: NL78279.058.21
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Sarcoma,Soft Tissue; Urothelial Carcinoma

Keywords

Prostate Specific Membrane Antigen; Soft Tissue Sarcoma; Urothelial Carcinoma; Urothelial Neoplasm; Transitional Cell Carcinoma; PSMA; PSMA PET/CT; JK-PSMA-7

Outcome Measures

Primary Outcomes (1)

• Quantify PSMA-tracer accumulation and determine whether SUV > 8

  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.

  6 months

Secondary Outcomes (5)

• Correlation between PSMA expression and PSMA-tracer uptake

  6 months

• Correlation PSMA expression and tumour grade, tumour stage and tumour subtype

  6 months

• Histological differences between primary tumours and metastases

  6 months

• Differences on [18F]-JK-PSMA-7 PET/CT between primary tumours and metastases

  6 months

• Agreement between [18F]-JK-PSMA-7 PET/CT and standard imaging

  6 months

Study Arms (1)

Advanced soft tissue sarcoma (n=60) and advanced urothelial cell carcinoma (n=60)

OTHER

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).

Diagnostic Test: [18F]-JK-PSMA-7 PET/CT scan

Interventions

[18F]-JK-PSMA-7 PET/CT scan DIAGNOSTIC_TEST

A \[18F\]-JK-PSMA-7 PET/CT scan will be made to assess the level of tracer uptake in the malignant lesion(s). We expect to make a \[18F\]-JK-PSMA-7 PET/CT scan in 15 out of 60 patients per cohort.

Advanced soft tissue sarcoma (n=60) and advanced urothelial cell carcinoma (n=60)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Centre

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

• Kleiburg 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 DERIVED

MeSH Terms

Conditions

Sarcoma; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Lioe-Fee De Geus-Oei, prof.dr.

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. L.F. de Geus-Oei

Model Details: This pilot study is a single centre, open-label, phase II study in patients with advanced soft tissue sarcoma (cohort 1) and advanced urothelial cell carcinoma (cohort 2). It is a non-randomized, non-blinded, prospective pilot study to assess the level of PSMA expression and the feasibility of PSMA-targeted theranostics in these patient groups. In all patients that are included in this pilot study, immunohistochemical PSMA staining will be performed on their biopsy material. In case of high PSMA expression, as defined by previous literature, a \[18F\]-JK-PSMA-7 PET/CT scan will be made to assess the level of tracer uptake in the malignant lesion(s). The expected duration of recruitment is 1 year and 9 months. An early stopping rule of 5 negative PSMA PET/CT scans is implemented in this study, for each cohort.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 31, 2022
• Study Start: August 1, 2022
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)