A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
ConditionProstate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorHoag Memorial Hospital Presbyterian
About this trial
Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production.
This phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy proven prostate adenocarcinoma
Age ≥ 18 years
ECOG 0 or 1
At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment
Disqualifiers
Known allergy/hypersensitivity to PSMA-targeted imaging agents
Other active malignancy, other than the known prostate cancer
Trial design
Design model
Single group
Treatments tested in this trial
Copper 61-PSMA PET/CT
DrugTEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Imaging Agent-Emergent Adverse Events [Safety and Tolerability]
For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration.
Time frame
Up to 24 hours after administration of radiotracerSecondary outcomes
1
Dosimetry
For the secondary objective of dosimetry, dosimetry will be calculated from PET/CT images and radioactive counts in blood samples by an experience medical physicist.
Time frame
Up to 24 hours after administration of radiotracer2
Number of suspected PSMA-positive malignant lesions
For the secondary objective of effectiveness, the number of suspected PSMA-positive malignant lesions will be calculated in both the standard-of-care 18F-Piflufolastat PET/CT and the experimental 61Cu-PSMA PET/CT. Positive lesions will be considered to be the foci greater than local background that are not physiologic/benign by location. The percentage of patients with any suspected PSMA-positive malignant lesions will be determined for each radiotracer.
Time frame
Up to 24 hours after administration of radiotracerSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov