Sarcoma,Soft TissueNCT05522257
PSMA Expression and PSMA PET Imaging in Soft Tissue Sarcomas and Urothelial Cell Carcinomas
A study testing [18F]-JK-PSMA-7 PET/CT scan in people with Sarcoma,Soft Tissue and Urothelial Carcinoma, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma,Soft Tissue, Urothelial Carcinoma
- What is being tested?
- [18F]-JK-PSMA-7 PET/CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2022to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression of Prostate Specific Membrane Antigen (PSMA) in Soft Tissue Sarcomas and Urothelial Cell Carcinomas: Implications for Tumour-specific Molecular Imaging and Treatment?
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.
Read the detailed description
Background:
Patients with metastatic soft tissue sarcoma and metastatic urothelial cell carcinoma have a poor prognosis, with a five-year survival rate of 16% and 6%, respectively. This is due to limited treatment options and low response rates to systemic chemotherapy of approximately 25% in soft tissue sarcomas and 40-50% in urothelial cell carcinomas. In these patient groups there is a high need for new effective treatment options that can decrease burden of disease and increase survival benefit.
Prostate specific membrane antigen (PSMA) is a transmembrane metallopeptidase that is overexpressed in prostate cancer cells. For diagnostic purposes, PET/CT scans that target PSMA have found their way into the clinical routine of prostate cancer patients. However, currently we know that despite the name, PSMA is not prostate cancer specific. It is also found in the tumour-associated blood vessels of a wide variety of other tumours, including soft tissue sarcomas and urothelial cell carcinomas. In many different sarcoma types, PSMA expression is seen in the neovasculature with the highest detection rate of 46-60% in high grade and undifferentiated sarcomas (e.g. pleomorphic sarcoma types). The PSMA expression rate in the neovasculature of urothelial cell carcinomas still varies in literature, however, the most recently published article showed that PSMA expression was found in 93% of urothelial cell carcinoma tissues. Additionally, PSMA expression was seen in the tumour cells itself in 79% of the tissues. Because of the unique expression pattern which seems to be limited to tumour cells and tumour-associated endothelial cells, PSMA may represent an interesting target for molecular imaging using PSMA-targeting PET scans, and eventually for radionuclide targeted therapy, when coupled to an alpha- or beta-emitter. [225Act]-PSMA and [177Lu]-PSMA therapy have shown promising results in the treatment of advanced prostate cancer patients and might offer perspective and increase quality of life in patients with advanced soft tissue sarcoma and urothelial cell carcinoma, as well.
Objective of the study:
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.
Study design:
This pilot study is a single centre, open-label, non-randomized, non-blinded phase II study with two patient cohorts.
Study population:
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). The expected duration of recruitment is 1 year and 9 months.
Intervention:
In all included patients, biopsy material is obtained as part of routine clinical practice. For this study, immunohistochemical PSMA staining will be performed on these biopsy materials. If the biopsy material shows 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). We expect to make a [18F]-JK-PSMA-7 PET/CT scan in 15 out of 60 patients in each cohort.
- Conditions
- Sarcoma,Soft Tissue, Urothelial Carcinoma
- Being tested
- [18F]-JK-PSMA-7 PET/CT scan
- Keywords
- Prostate Specific Membrane Antigen, Soft Tissue Sarcoma, Urothelial Carcinoma, Urothelial Neoplasm, Transitional Cell Carcinoma, PSMA, PSMA PET/CT, JK-PSMA-7
- Medical subject headings
- Sarcoma, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-JK-PSMA-7 PET/CT scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: [18F]-JK-PSMA-7 PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Correlation between PSMA expression and PSMA-tracer uptake
Assessing if higher levels of PSMA expression in biopsy material result in higher levels of PSMA-tracer uptake on a [18F]-JK-PSMA-7 PET/CT scan.
Measured: 6 months
Correlation PSMA expression and tumour grade, tumour stage and tumour subtype
The correlation between PSMA expression in biopsy material and tumour grade, tumour stage (TNM system) and histological subtype, as concluded by the pathologist.
Measured: 6 months
Histological differences between primary tumours and metastases
The immunohistochemical PSMA expression pattern in primary tumours vs. metastases
Measured: 6 months
Differences on [18F]-JK-PSMA-7 PET/CT between primary tumours and metastases
Quantified PSMA-tracer uptake (SUVmax) in primary tumours vs. metastases
Measured: 6 months
Agreement between [18F]-JK-PSMA-7 PET/CT and standard imaging
The number of detected lesions on [18F]-JK-PSMA-7 PET/CT vs. standard imaging (CT or [18F]-FDG PET/CT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Aug 2022
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma,Soft TissueStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lioe-Fee de Geus-Oei, MD PhD, Leiden University Medical Center
- Investigators
- Lioe-Fee De Geus-Oei, prof.dr., Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522257
- Sponsor's protocol ID
- NL78279.058.21
- Status last verified
- Dec 2024
- First submitted
- 16 Aug 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data includes medical history and imaging data, which cannot be completely anonymized.
Publications
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.
PubMed 40146266
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Prostate Specific Membrane Antigen (PSMA) in Soft Tissue Sarcomas and Urothelial Cell Carcinomas: Implications for Tumour-specific Molecular Imaging and Treatment?
- ClinicalTrials.gov ID
- NCT05522257
- Acronym / sponsor ID
- NL78279.058.21
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Patients with metastatic soft tissue sarcoma and metastatic urothelial cell carcinoma have a poor prognosis, with a five-year survival rate of 16% and 6%, respectively. This is due to limited treatment options and low response rates to systemic chemotherapy of approximately 25% in soft tissue sarcomas and 40-50% in urothelial cell carcinomas. In these patient groups there is a high need for new effective treatment options that can decrease burden of disease and increase survival benefit.
Prostate specific membrane antigen (PSMA) is a transmembrane metallopeptidase that is overexpressed in prostate cancer cells. For diagnostic purposes, PET/CT scans that target PSMA have found their way into the clinical routine of prostate cancer patients. However, currently we know that despite the name, PSMA is not prostate cancer specific. It is also found in the tumour-associated blood vessels of a wide variety of other tumours, including soft tissue sarcomas and urothelial cell carcinomas. In many different sarcoma types, PSMA expression is seen in the neovasculature with the highest detection rate of 46-60% in high grade and undifferentiated sarcomas (e.g. pleomorphic sarcoma types). The PSMA expression rate in the neovasculature of urothelial cell carcinomas still varies in literature, however, the most recently published article showed that PSMA expression was found in 93% of urothelial cell carcinoma tissues. Additionally, PSMA expression was seen in the tumour cells itself in 79% of the tissues. Because of the unique expression pattern which seems to be limited to tumour cells and tumour-associated endothelial cells, PSMA may represent an interesting target for molecular imaging using PSMA-targeting PET scans, and eventually for radionuclide targeted therapy, when coupled to an alpha- or beta-emitter. [225Act]-PSMA and [177Lu]-PSMA therapy have shown promising results in the treatment of advanced prostate cancer patients and might offer perspective and increase quality of life in patients with advanced soft tissue sarcoma and urothelial cell carcinoma, as well.
Objective of the study:
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.
Study design:
This pilot study is a single centre, open-label, non-randomized, non-blinded phase II study with two patient cohorts.
Study population:
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). The expected duration of recruitment is 1 year and 9 months.
Intervention:
In all included patients, biopsy material is obtained as part of routine clinical practice. For this study, immunohistochemical PSMA staining will be performed on these biopsy materials. If the biopsy material shows 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). We expect to make a [18F]-JK-PSMA-7 PET/CT scan in 15 out of 60 patients in each cohort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Advanced soft tissue sarcoma (n=60) and advanced urothelial cell carcinoma (n=60) | Other | Diagnostic Test: [18F]-JK-PSMA-7 PET/CT scanThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-JK-PSMA-7 PET/CT scanA [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. | Diagnostic test | Advanced soft tissue sarcoma (n=60) and advanced urothelial cell carcinoma (n=60) |
Primary outcome
Quantify PSMA-tracer accumulation and determine whether SUV > 8
Time frame: 6 months
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.
5 secondary outcomes
Correlation between PSMA expression and PSMA-tracer uptake
Time frame: 6 months
Correlation PSMA expression and tumour grade, tumour stage and tumour subtype
Time frame: 6 months
Histological differences between primary tumours and metastases
Time frame: 6 months
Differences on [18F]-JK-PSMA-7 PET/CT between primary tumours and metastases
Time frame: 6 months
Agreement between [18F]-JK-PSMA-7 PET/CT and standard imaging
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 40146266Kleiburg 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.
- Individual participant dataSharing planned: No. Patient data includes medical history and imaging data, which cannot be completely anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lioe-Fee De Geus-Oei, prof.dr. principal investigator
Leiden University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]-JK-PSMA-7 PET/CT scan in people with Sarcoma,Soft Tissue and Urothelial Carcinoma, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify PSMA-tracer accumulation and determine whether SUV > 8 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.