Copper 61 Imaging for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Hoag Memorial Hospital Presbyterian

Disqualifiers: Allergy to PSMA agents, other malignancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

8 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Copper 61-PSMA PET/CT, 61Cu-NODAGA-PSMA I&T, 61Cu-NuriPro for prostate cancer?

Research on similar treatments using copper-64 (64Cu) for prostate cancer imaging shows high diagnostic potential and specific uptake in prostate cancer cells, suggesting that Copper 61-PSMA PET/CT could also be effective for imaging prostate cancer. ^{1 2 3 4 5}

Is Copper 61 Imaging for Prostate Cancer safe for humans?

Research on similar copper-labeled compounds for prostate cancer imaging, like 64Cu-PSMA, shows they are generally safe in preclinical studies, with high stability and specific tumor targeting. However, these studies also note high uptake in the kidneys and liver, which may require monitoring in human trials. ^{2 3 4 6 7}

What makes the Copper 61-PSMA PET/CT treatment unique for prostate cancer?

Copper 61-PSMA PET/CT is unique because it uses a copper isotope for imaging, which may offer better logistical advantages and imaging performance compared to other isotopes like 18F and 68Ga. This treatment targets prostate-specific membrane antigen (PSMA) to visualize prostate cancer lesions with high contrast, potentially improving diagnosis and therapy planning. ^{1 2 4 6 7}

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.

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.

My prostate cancer was confirmed through a biopsy.

Exclusion Criteria

Known allergy/hypersensitivity to PSMA-targeted imaging agents

I have no active cancer other than my known prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Subjects will undergo imaging with 100-300 MBq of 61Cu-NODAGA-PSMA intravenously, followed by PET/CT imaging 60 minutes post radiotracer administration

1 day

1 visit (in-person)

Safety Monitoring

Side effects will be monitored the day of and the day following radiotracer administration

Up to 24 hours

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-2 weeks

Treatment Details

Interventions

• Copper 61-PSMA PET/CT

Trial Overview 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.

Participant Groups

Group I: Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CT Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Hoag Memorial Hospital Presbyterian

Lead Sponsor

Trials

37

Recruited

17,200+

Findings from Research

In a study of 23 prostate cancer patients, 64Cu-PSMA PET-CT imaging effectively detected residual disease, with significant uptake observed in the prostate bed, lymph nodes, and distant metastases, highlighting its diagnostic potential.

The imaging showed increased tracer uptake over time, suggesting that 64Cu NODAGA-PSMA is stable and reliable for detecting prostate cancer progression, with a significant correlation between the number of positive uptake sites and pre-imaging PSA levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer. Sevcenco, S., Klingler, HC., Eredics, K., et al.[2021]

In a study involving LNCaP tumor-bearing mice, treatment with 64Cu-DOTHA2-PSMA significantly improved survival compared to the control group receiving natCu-DOTHA2-PSMA, indicating its potential as an effective therapeutic option for prostate cancer.

The treatment with 64Cu-DOTHA2-PSMA showed acceptable safety, with normal red blood cell counts and no significant signs of radiation injury, although there was some concern regarding hepatic and gastrointestinal irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theranostic 64Cu-DOTHA2-PSMA allows low toxicity radioligand therapy in mice prostate cancer model. Milot, MC., Bélissant-Benesty, O., Dumulon-Perreault, V., et al.[2023]

The radiolabeled ligand [64Cu]PSMA-617 demonstrated high radiochemical purity (>99%) and specific uptake in prostate cancer cells, indicating its potential for effective PET imaging of prostate cancer.

In vivo studies showed that [64Cu]PSMA-617 successfully visualized tumor areas in mice, although it exhibited slow clearance from the kidneys and high uptake in the liver, suggesting that modifications to its structure could enhance its use in imaging and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and evaluation of [64Cu]PSMA-617 targeted for prostate-specific membrane antigen in prostate cancer. Cui, C., Hanyu, M., Hatori, A., et al.[2020]

The 64Cu-PSMA-BCH radiopharmaceutical demonstrated high stability and specificity for prostate-specific membrane antigen (PSMA), showing significantly higher uptake in PSMA-positive cancer cells compared to PSMA-negative cells, which suggests its potential effectiveness for prostate cancer imaging.

In clinical applications, delayed imaging at 6 and 24 hours post-injection improved tumor detection rates, indicating that this radiopharmaceutical could enhance the accuracy of targeted biopsies in patients with suspected prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer. Liu, T., Liu, C., Zhang, Z., et al.[2021]

In a study of 100 prostate cancer patients, both [64Cu]-DOTAGA-PSMA and [18F]-PSMA PET-CT imaging showed similar effectiveness in detecting PSMA-positive lesions, with [64Cu]-DOTAGA-PSMA identifying a total of 209 lesions compared to 191 for [18F]-PSMA.

While both imaging techniques had comparable detection rates, the median number of lesions detected was slightly lower for [64Cu]-DOTAGA-PSMA, and the liver uptake values differed, indicating that the two methods may not be directly comparable in terms of SUV measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Center Comparison of [64Cu]-DOTAGA-PSMA and [18F]-PSMA PET-CT for Imaging Prostate Cancer. Mirzaei, S., Lipp, R., Zandieh, S., et al.[2021]

The study demonstrated that 64Cu labeling of PSMA I&T is highly effective, achieving over 95% labeling yield and maintaining over 90% stability in serum for up to 60 hours, making it a promising candidate for prostate cancer imaging.

In vivo tests showed that 64Cu-PSMA I&T specifically binds to prostate cancer cells (22RV1) significantly better than non-target cells (PC-3), with tumor uptake increasing over time, indicating its potential for effective PET imaging in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer. Lee, CH., Lim, I., Woo, SK., et al.[2022]

The novel 64Cu-labeled PSMA ligands demonstrated high serum stability and effective targeting of prostate tumors, with significant tumor uptake observed in preclinical studies, indicating their potential for accurate imaging and treatment.

In a patient application, the compound CA003 provided clear visualization of cancer lesions, supporting its use for diagnostics and therapy planning in prostate cancer, particularly in conjunction with the therapeutic isotope 67Cu.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Novel PSMA Ligands for Imaging and Therapy with Copper Isotopes. Carlos Dos Santos, J., Beijer, B., Bauder-Wüst, U., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Theranostic 64Cu-DOTHA2-PSMA allows low toxicity radioligand therapy in mice prostate cancer model. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Synthesis and evaluation of [64Cu]PSMA-617 targeted for prostate-specific membrane antigen in prostate cancer. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Single-Center Comparison of [64Cu]-DOTAGA-PSMA and [18F]-PSMA PET-CT for Imaging Prostate Cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Development of Novel PSMA Ligands for Imaging and Therapy with Copper Isotopes. [2020]