A new Phase I clinical trial is underway to evaluate the safety and effectiveness of a novel molecular imaging (MI) radiotracer that utilizes Copper-61 (61Cu) to image prostate cancer. The study, titled “A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer,” explores the potential of 61Cu-NODAGA-PSMA, a compound that targets Prostate Specific Membrane Antigen (PSMA), a protein found on prostate cancer cells.

Current MI agents commonly use isotopes such as Fluorine-18 or Gallium-68, which have short half-lives that can limit the geographic distribution of tracers. Copper-61 (61Cu), with a 3.3-hour half-life, could overcome this limitation and allow for greater distribution of the radiotracer. This is an important factor in making the technology more accessible.

The Phase I trial is designed as a non-randomized, single-group assignment study with an open label. It will enroll an estimated 8 participants diagnosed with prostate adenocarcinoma. These patients must have at least one site of PSMA-positive disease on a PSMA-targeted PET/CT scan performed within 30 days of trial recruitment. Eligible participants also need an ECOG score of 0 or 1, and meet specific creatinine level criteria. Exclusion criteria include known allergies to PSMA-targeted imaging agents or other active malignancies.

Participants will receive an intravenous injection of 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA, followed by a PET/CT scan approximately 60 minutes later. The trial’s primary goal is to assess the safety of the radiotracer, with side effects monitored on the day of and the day after administration. As the PET radiotracer is used at a low imaging dose, serious adverse events are not expected. If any serious adverse event is reported the trial will be put on hold and reviewed by the IRB.
The study also has secondary objectives, including dosimetry calculations performed by experienced medical physicists from PET/CT images and radioactive counts in blood samples. Another secondary objective is to determine the effectiveness of 61Cu-NODAGA-PSMA by calculating the number of suspected PSMA-positive malignant lesions observed, compared with standard-of-care 18F-Piflufolastat PET/CT scans. This also includes determining the percentage of patients with these suspected lesions.

The successful development of 61Cu-NODAGA-PSMA has the potential to advance this novel radioisotope into Phase II trials and could lead to a new paradigm in MI radioisotope production.

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