The primary objective is to investigate if ADT can increase the uptake of 68Ga-PSMA in patients with R/M SDC.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of patients with an ADT induced increase in PSMA ligand uptake
on 68Ga-PSMA-PET/CT.
Secondary outcome
- standardised uptake values (SUV) of recurrence and/or metastases in
68Ga-PSMA-PET/CT pre- and post ADT.
- standardised uptake values of recurrence and/or metastases in 18FDG-PET/CT
pre- and post ADT.
- correlation between SUV and the degree of immunohistochemical PSMA
expression.
Background summary
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.
Our research group investigates whether these findings also apply to salivary
gland cancer (SGC), a rare cancer. Previously we conducted a phase II 68Ga-PSMA
imaging study, to evaluate PSMA ligand uptake in locally advanced, recurrent
and metastatic ACC and SDC (two subtypes of SGC). We observed intense
PSMA-ligand uptake in 93% of ACC patients and 40% of SDC patients. A phase II
therapeutic study with 177Lu-PSMA RLT in advanced SGC will follow (upcoming
study).
However, since 60% of SDC patients showed low ligand uptake, they are not
suitable for this 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 we aim 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.
Study 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 burden and risks
Participants will undergo two 68Ga-PSMA-PET/CT, two 18FDG-PET/CT and
venapunctures. These are standard diagnostic procedures with a known minimal
safety risk. The participant will be asked to make five study related visits. A
participant will not benefit from participating in this study. The study does
not involve minor or incapacitated subjects.
Optional part: one or two biopsies.
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Listed location countries
Age
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 re-commended by the treating physician as standard treatment.
Exclusion criteria
• Contra-indication for PET imaging: pregnancy or breast feeding or 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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003262-41-NL |
| CCMO | NL71139.091.19 |