Clinical trial NCT04214353: PSMA-PET Imaging Before and After ADT in Advanced SDC Patients
Official title: Effect of Androgen Deprivation Therapy on Uptake of PSMA Ligand in Patients With Salivary Duct Carcinoma: an Explorative Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Salivary Gland Cancer
Salivary Duct Carcinoma
Keywords: Positron-Emission Tomography
68Ga-PSMA-PET/CT
18FDG-PET/CT
Androgen deprivation therapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2020-01-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients with a change in PSMA ligand uptake after ADT
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Change in 68Ga-PSMA uptake of tumor lesions
timeFrame: Up to 4 weeks
measure: Change in 18FDG uptake of tumor lesions
timeFrame: Up to 4 weeks
measure: Lesions detected by 68Ga-PSMA-PET/CT pre- and post ADT
timeFrame: Up to 4 weeks
measure: FDG and PSMA uptake patterns of SDC disease
timeFrame: Up to 4 weeks
measure: Diagnostic added value 68Ga-PSMA-PET/CT and 18FDG-PET/CT.
timeFrame: Up to 4 weeks
measure: Correlation PSMA expression and PSMA ligand uptake
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: