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

Effect of Androgen Deprivation Therapy on Uptake of PSMA Ligand in Patients With Salivary Duct Carcinoma: an Explorative Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Salivary Gland Cancer; Salivary Duct Carcinoma
• Intervention / Treatment: Diagnostic test: 68Ga-PSMA-PET/CT; Diagnostic test: 18FDG-PET/CT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Recruiting
      • Radboudumc
      • Contact: Carla ML van Herpen, MD, PhD; Phone Number: +31243613457; Email: Carla.vanHerpen@radboudumc.nl
      • Principal Investigator: Carla ML van Herpen, MD, PhD
      • Sub-Investigator: Martin Gotthardt, MD, PhD
      • Sub-Investigator: James Nagarajah, MD, PhD
      • Sub-Investigator: Maike JM Uijen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; 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.	Diagnostic test: 68Ga-PSMA-PET/CT; All participants in the study will be injected with 2.0 MBq/kg 68Ga-PSMA for PET/CT imaging, both pre- and post ADT.; Diagnostic test: 18FDG-PET/CT; All participants in the study will be injected with 2.1 MBq/kg 18FDG for PET/CT imaging, both pre- and post ADT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a change in PSMA ligand uptake after ADT	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).	Up to 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Dutch Cancer Society

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Positron-Emission Tomography; Androgen deprivation therapy; 68Ga-PSMA-PET/CT; 18FDG-PET/CT
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma; Salivary Gland Neoplasms; Carcinoma, Ductal; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: MOHN19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No