Copper 61 Imaging for Prostate Cancer
Palo Alto (17 mi)Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Hoag Memorial Hospital Presbyterian
No Placebo Group
Trial Summary
What is the purpose of 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.
What data supports the idea that Copper 61 Imaging for Prostate Cancer is an effective treatment?The available research shows that Copper 64 Imaging, which is similar to Copper 61 Imaging, is effective for prostate cancer. Studies have shown that Copper 64 Imaging can successfully identify prostate cancer cells in both early and advanced stages. For example, one study found that Copper 64 Imaging had high accuracy in detecting cancer in patients with recurrent disease. Another study demonstrated that Copper 64 Imaging could visualize tumor areas in mice, indicating its potential for effective imaging in humans. Additionally, when compared to another imaging method using a different substance, Copper 64 Imaging showed comparable or better results in identifying cancer. This suggests that Copper 61 Imaging could also be effective for prostate cancer.12567
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is Copper 61-PSMA PET/CT a promising treatment for prostate cancer?Yes, Copper 61-PSMA PET/CT is a promising treatment for prostate cancer. It uses a special imaging technique to target prostate cancer cells, helping doctors see the cancer more clearly. This can improve diagnosis and treatment planning, making it a valuable tool in managing prostate cancer.23457
What safety data exists for Copper 61 imaging in prostate cancer treatment?The research provided does not directly address Copper 61 imaging but focuses on Copper 64-labeled PSMA ligands, which are similar in purpose. These studies indicate that Copper 64-labeled compounds, such as 64Cu-PSMA-617, 64Cu-PSMA I&T, and others, have been evaluated for their stability, biodistribution, and imaging potential in prostate cancer models. They show high radiolabeling efficiency, specific uptake in PSMA-positive tumors, and favorable imaging characteristics. Safety data from these studies suggest that these compounds have high serum stability and specific tumor uptake, with some showing rapid clearance from non-target organs like the kidneys. However, specific safety data for Copper 61 imaging is not provided in the research abstracts.13457
Eligibility Criteria
This trial is for patients with prostate adenocarcinoma, a type of prostate cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a confirmed diagnosis.Inclusion Criteria
I am fully active or restricted in physically strenuous activity but can do light work.
My kidney function is normal or only slightly impaired.
I am 18 years old or older.
My prostate cancer was confirmed through a biopsy.
Exclusion Criteria
I have no active cancer other than my known prostate cancer.
Treatment Details
The trial is testing the safety and effectiveness of a new molecular imaging tracer called 61Cu-NODAGA-PSMA. This tracer uses Copper 61 for PET/CT scans to image prostate cancer more effectively over greater distances due to its longer half-life.
1Treatment groups
Experimental Treatment
Group I: Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CTExperimental Treatment1 Intervention
TEST 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Hoag Memorial Hospital PresbyterianIrvine, CA
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Who is running the clinical trial?
Hoag Memorial Hospital PresbyterianLead Sponsor
References
Synthesis and evaluation of [64Cu]PSMA-617 targeted for prostate-specific membrane antigen in prostate cancer. [2020]We radiolabeled a ligand, PSMA-617, of prostate-specific membrane antigen (PSMA) with copper-64 (64Cu), to evaluate the metabolism, biodistribution, and potential of [64Cu]PSMA-617 for PET imaging of prostate cancer. [64Cu]PSMA-617 was synthesized by heating PSMA-617 with [64Cu]CuCl2 in buffer solution at 90°C for 5 min. In vitro uptake was determined in two cell lines of prostate cancer. In vivo regional distributions were determined in normal and tumor-bearing mice. High radiolabeling efficiency of 64Cu for PSMA-617 yielded [64Cu]PSMA-617 with >99% radiochemical purity. In vitro cellular uptake experiments demonstrated the specificity of [64Cu]PSMA-617 for PSMA-positive LNCaP cells. Biodistribution observations of normal mice revealed high uptake of radioactivity in the kidney and liver. PET with [64Cu]PSMA-617 visualized tumor areas implanted by PSMA-positive LNCaP cells in the mice. Two hours after the injection of [64Cu]PSMA-617 into mice, a radiolabeled metabolite was observed in the blood, liver, urine, and LNCaP tumor tissues. [64Cu]PSMA-617 was easily synthesized, and exhibited a favorable biodistribution in PSMA-positive tumors. Although this radioligand shows slow clearance for kidney and high liver uptake, change of its chelator moiety and easy radiolabeling may enable development of new 64Cu or 67Cu-labeled PSMA ligands for imaging and radiotherapy.
Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer. [2021]Label="INTRODUCTION">The high diagnostic potential of 64Cu-PSMA PET-CT imaging was clinically investigated in prostate cancer patients with recurrent disease and in the primary staging of selected patients with advanced local disease. The aim of our study is to assess the uptake behavior in the clinical setting of 64Copper Prostate-Specific Membrane Antigen (64Cu PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) in prostate cancer.
Development of Novel PSMA Ligands for Imaging and Therapy with Copper Isotopes. [2020]Prostate-specific membrane antigen (PSMA)-binding tracers have been shown to be promising agents for the specific targeting of prostate tumors. On labeling with the short-lived isotopes 18F and 68Ga, excellent molecular imaging performance is achieved. This potential could be further exploited using long-lived isotopes. Because of the favorable half-life of 64Cu, tracers labeled with this PET nuclide could solve logistic problems. Moreover, this isotope provides a theranostic pair with the therapeutic copper isotope 67Cu. Hence, 9 novel tracers that combine dedicated copper chelators with the PSMA-specific urea-based binding motif were developed. Methods: The precursors were obtained by solid-phase synthesis. The purity and molecular weight of the PSMA ligands were confirmed by high-performance liquid chromatography and liquid chromatography-mass spectrometry. The compounds were labeled with 64Cu, with a radiolabeling yield of more than 99%. Competitive cell binding assays and internalization assays were performed with C4-2 cells, a subline of the PSMA-positive cell line LNCaP (human lymph node carcinoma of the prostate). In vitro serum stability, the stability of 64Cu-CA003 in blood, and the in vivo fate of neat 64Cu-chloride or 64Cu-CA003 were determined to prove whether the stability of the radiolabeled compounds is sufficient to ensure no significant loss of copper during the targeting process. For PET imaging and biodistribution studies, a C4-2 tumor-bearing mouse model was used. Results: The radiolabeled 64Cu-PSMA ligands showed high serum stability. All PSMA ligands showed high inhibition potencies, with equilibrium inhibition constants in the low nanomolar range. 64Cu-CA003 and 64Cu-CA005 showed high internalization ratios (34.6% ± 2.8 and 18.6% ± 4.4, respectively). Both the in vitro serum stability determination and the in vivo characterization of the main radiolabeled compounds confirmed that, except for 64Cu-PSMA-617, all compounds showed high serum stability within the observation period of 24 h. Small-animal PET imaging demonstrated high tumor uptake within 20 min. Organ distribution studies confirmed high specific uptake in the tumor, with 30.8 ± 12.6 percentage injected dose (%ID)/g at 1 h after injection. Rapid clearance from the kidneys was observed-a decrease from 67.0 ± 20.9 %ID/g at 1 h after injection to 7.5 ± 8.51 %ID/g at 24 h after injection (in the case of CA003). The performance of CA003, the compound with the best preclinical properties, was assessed in a first patient. In line with its preclinical data, PET imaging resulted in clear visualization of the cancer lesions, with high contrast. Conclusion: The 64Cu-labeled PSMA ligands are promising agents to target PSMA and visualize PSMA-positive tumor lesions as shown in preclinical evaluation by small-animal PET studies, organ distribution, and a patient application. Most importantly, the images obtained at 20 h enabled delineation of unclear lesions, showing that the compounds fulfill the prerequisite for dosimetry in the course of therapy planning with 67Cu. Thus, we suggest clinical use of copper-labeled CA003 for diagnostics and radiotherapy of prostate cancer.
The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer. [2022]Background: The goal of this research was to investigate the feasibility of 64Cu labeling in prostate-specific membrane antigen imaging and therapy (PSMA I&T) for PSMA positron emission tomography (PET) imaging and biodistribution evaluation. Materials and Methods: PSMA I&T was labeled with 64Cu, and stability in human and mouse sera was evaluated. Prostate cancer cell lines were used for specific uptake assays (22RV1 for PSMA-positive, PC-3 for -negative). Both PC-3 and 22RV1 cells were transplanted into the left and right thighs in a mouse for PET/computed tomography (CT) imaging. Biodistribution was performed using 22RV1 tumor models. Results: Labeling yield (decay corrected) of 64Cu-PSMA I&T was more than 95% compared to the free 64Cu peak. The serum stability of 64Cu-PSMA I&T was maintained at more than 90% until 60 h. Regarding the specific binding of 64Cu-PSMA I&T was 7.5-fold higher to 22RV1 cells than PC-3 cells (p < 0.001). On PET/CT imaging, more specific 64Cu-PSMA I&T uptake was observed to 22RV1 tumors than to PC-3 tumors. In the PSMA blocking study using 2-phosphonomethoxypropyl adenine (2-PMPA), the 64Cu-PSMA I&T signal significantly decreased in the 22RV1 tumor region. In the biodistribution study, the kidney uptake was the highest among all organs at 2 h (52.6 ± 20.8%ID/g) but sharply decreased at 24 and 48 h. Also, the liver showed similar uptake over time (range, 10-12%ID/g). On the contrary, 64Cu-PSMA I&T uptake of the tumors increased with time and peaked at 48 h (5.6 ± 0.1%ID/g). Conclusions: PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging through in vitro and in vivo studies. Furthermore, 64Cu-PSMA I&T might be considered as the candidate of future clinical trial.
64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer. [2021]Label="PURPOSE">Develop a 64Cu labeled radiopharmaceutical targeting prostate specific membrane antigen (PSMA) and investigate its application for prostate cancer imaging.
Single-Center Comparison of [64Cu]-DOTAGA-PSMA and [18F]-PSMA PET-CT for Imaging Prostate Cancer. [2021]Label="INTRODUCTION">the diagnostic performance of [64Cu]-DOTAGA-PSMA PET-CT imaging was compared retrospectively to [18F]-PSMA PET-CT in prostate cancer patients with recurrent disease and in the primary staging of selected patients with advanced local and possible metastatic disease.
Theranostic 64Cu-DOTHA2-PSMA allows low toxicity radioligand therapy in mice prostate cancer model. [2023]Label="Introduction" NlmCategory="UNASSIGNED">We have previously shown that copper-64 (64Cu)-DOTHA2-PSMA can be used for positron emission tomography (PET) imaging of prostate cancer. Owing to the long-lasting, high tumoral uptake of 64Cu-DOTHA2-PSMA, the objective of the current study was to evaluate the therapeutic potential of 64Cu-DOTHA2-PSMA in vivo.