PSMA-PET Imaging Before and After ADT in Advanced SDC Patients

Not Applicable

• Conditions: Salivary Duct Carcinoma; Salivary Gland Cancer
• Interventions: Diagnostic Test: 68Ga-PSMA-PET/CT; Diagnostic Test: 18FDG-PET/CT

• Registration Number: NCT04214353
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Explorative study, which evaluates the effect of androgen deprivation therapy (ADT) on the PSMA ligand uptake on 68Ga-PSMA-PET/CT in salivary duct carcinoma patients.

Detailed Description

Rationale: Prostate specific membrane antigen (PSMA) is a transmembrane protein, which is expressed on prostate cancers cells and other malignancies. Recently, several ligands have been developed that target PSMA. Linked to Gallium-68, this enables diagnostic 68Ga-PSMA-PET/CT scans. Linked to Lutetium-177 enables therapeutic 177Lu-PSMA Radioligand therapy. Most research on the diagnostic and therapeutic possibilities of PSMA has been conducted in patients with advanced prostate cancer.

This research group investigates whether these findings also apply to salivary gland cancer (SGC), a rare cancer. Previously the investigators conducted a phase II 68Ga-PSMA imaging study (NCT03319641), to evaluate PSMA ligand uptake in locally advanced, recurrent and metastatic ACC and SDC (two subtypes of SGC). A relevant PSMA-ligand uptake was observed in 93% of ACC patients and 40% of SDC patients. However, since 60% of SDC patients showed low ligand uptake, these patients are not suitable for PSMA radioligand therapy. For advanced SDC, androgen deprivation therapy is often given as first-line treatment, because the majority of SDCs are androgen receptor positive. In prostate cancer, androgen deprivation therapy (ADT) can increase PSMA-ligand uptake. Therefore the aim is to investigate if ADT can increase the uptake of 68Ga-PSMA in patients with R/M SDC, as has previously been demonstrated in prostate cancer.

Objective: The primary objective is to investigate if ADT can increase the uptake of 68Ga-PSMA in patients with R/M SDC.

Study design: Interventional clinical trial, an explorative study. Study population: Patients with locally advanced, recurrent or metastatic (R/M) SDC AR+ and who will start ADT as standard of care.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2020-01-02
• Study Start: 2020-01-14
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16
• Primary Completion: 2023-05
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patients must have the ability to provide written informed consent.
• Patients must be ≥ 18 years of age.
• Patients must have histological, pathological, and/or cytological confirmation of salivary duct carcinoma, androgen receptor positive.
• Only patients with locally advanced, recurrent or metastatic salivary duct carcinoma can participate.
• Patients must have at least one lesion with a diameter of ≥ 1.5 cm.
• Patients whom intend to start androgen deprivation therapy, after this has been recommended by the treating physician as standard treatment.

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Exclusion Criteria

• Contra-indication for PET imaging (pregnancy, breast feeding severe claustrophobia)
• Impaired renal function: MDRD <30 ml/min/1,73 m2
• Impaired liver function: AST and ALT ALT ≥ 2.5 x ULN (≥5 x ULN for patients with liver metastases)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	18FDG-PET/CT	Salivary duct carcinoma patients with R/M disease, who will start androgen deprivation therapy as standard of care will receive PET/CT scans before and after ADT.
Experimental arm	68Ga-PSMA-PET/CT	Salivary duct carcinoma patients with R/M disease, who will start androgen deprivation therapy as standard of care will receive PET/CT scans before and after ADT.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a change in PSMA ligand uptake after ADT	Up to 4 weeks	The percentage of patients with an androgen deprivation therapy (ADT) induced change in PSMA ligand uptake on 68Ga-PSMA-PET/CT.; pre-scan: baseline (before ADT), post-scan: 3 weeks after start ADT (± 1 week).

Secondary Outcome Measures

Name	Time	Method
Change in 68Ga-PSMA uptake of tumor lesions	Up to 4 weeks	Comparison of SUV (standardized uptake value) in 68Ga-PSMA PET/CT between lesions before and 3 weeks after the initiation of ADT (± 1 week).
Change in 18FDG uptake of tumor lesions	Up to 4 weeks	Comparison of SUV (standardized uptake value) in 18FDG-PET/CT between lesions before and 3 weeks after the initiation of ADT (± 1 week).
Lesions detected by 68Ga-PSMA-PET/CT pre- and post ADT	Up to 4 weeks	The number of lesions detected on 68Ga-PSMA-PET/CT imaging will be measured, both before and after ADT.
FDG and PSMA uptake patterns of SDC disease	Up to 4 weeks	FDG and PSMA uptake patterns of SDC disease on 68Ga-PSMA-PET/CT and 18FDG-PET/CT will be measured, e.g. to explore if most lesions show both FDG and PSMA uptake, or if the lesions show a more heterogenous uptake.
Correlation PSMA expression and PSMA ligand uptake	Up to 6 months	The tumor uptake (SUV) will be correlated to the degree of immunohistochemical PSMA expression on the most recent tumormaterial.
Diagnostic added value 68Ga-PSMA-PET/CT and 18FDG-PET/CT.	Up to 4 weeks	The number of lesions detected by each imaging modality (diagnostic CT, 68Ga-PSMA-PET/CT and 18FDG-PET/CT) will be measured.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands