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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new method to image prostate cancer using a special tracer called Copper 61-PSMA. The goal is to determine if this tracer is safe and effective for detecting prostate cancer in the body. This new tracer could enhance cancer visibility and reach more distant areas due to its longer-lasting properties. Men with prostate cancer that appears on PSMA scans might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative imaging method.

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 prior data suggests that this radiotracer is safe for imaging prostate cancer?

Previous studies have shown that the Copper 61-PSMA PET/CT treatment is generally safe for imaging prostate cancer. Research indicates that this special imaging agent, which uses Copper 61, effectively identifies areas with PSMA, a protein found in prostate cancer cells.

Patients who received this treatment did not report major safety issues, suggesting it is well-tolerated for imaging purposes. As this is a phase 1 trial, the main focus is on ensuring safety, with close monitoring of any side effects. So far, the findings are promising and demonstrate that the treatment is safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about Copper 61-PSMA PET/CT because it offers a new way to visualize prostate cancer using a radioactive tracer called Copper 61. Unlike traditional imaging methods, this technique specifically targets PSMA (Prostate-Specific Membrane Antigen), a protein highly expressed in prostate cancer cells. This targeted approach could provide clearer images, helping doctors to detect cancer more accurately and potentially at an earlier stage. Additionally, Copper 61 has a shorter half-life compared to other radioactive tracers, which may lead to quicker imaging processes and less radiation exposure for patients.

What evidence suggests that this Copper 61 imaging technique is effective for prostate cancer?

Research has shown that Copper 61-PSMA PET/CT imaging holds promise for detecting prostate cancer. In a previous study, this imaging method successfully identified cancer with a specific marker called PSMA in patients with prostate cancer. In this trial, participants will undergo imaging with the new tracer, 61Cu-NODAGA-PSMA, designed to enhance cancer imaging by lasting longer in the body than tracers like Fluorine 18. Studies have also found that this imaging method detected more cancer spots up to four hours after administration compared to some existing tracers. This suggests that 61Cu-PSMA could potentially provide clearer and more detailed images for detecting prostate cancer. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251058

A Phase 1 Trial of 61Cu-NODAGA-PSMA I&T for Patients ... In this phase 1 trial, 61 Cu-NODAGA-PSMA I&T PET/CT is safe and effective at imaging PSMA-avid malignancy in patients with prostate cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11372264/

61Cu-PSMA–Targeted PET for Prostate Cancer This preclinical study introduced 61 Cu-labeled PSMA tracers and identified [ 61 Cu]Cu-NODAGA-PSMA-I&T as a suitable radiotracer for PSMA PET imaging.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06736054

NCT06736054 | A Phase I Trial of 61Cu-NODAGA-PSMA ... 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 ...

4. urotoday.com urotoday.com/conference-highlights/snmmi-2025/161556-snmmi-2025-a-phase-1-trial-of-61cu-nodaga-psma-i-t-for-patients-with-prostate-cancer.html

SNMMI 2025: A Phase 1 Trial of 61Cu-NODAGA-PSMA I&T ... This is a phase I trial that aimed to evaluate the safety, dosimetry, and optimal imaging parameters of 61 Cu-NODAGA-PSMA I&T.

5. nuclidium.com nuclidium.com/nuclidium-presents-positive-phase-1-results-of-its-novel-pet-imaging-agent-61-cu-nuriprotm-at-snmmi-2025-annual-meeting/

Presents Positive Phase 1 Results of its Novel PET ... 61Cu-NuriPro™ detected more lesions up to 4 hours post-administration in 50% of patients, not visualized by 18F-piflufolastat PET[2].

6. pubs.acs.org pubs.acs.org/doi/10.1021/acsptsci.4c00685

In vivo Evaluation of Copper-61-Labeled Prostate-specific ... As seen in Figure 3B the tumors became visible already 30 min after [61Cu]Cu-KFTG-PSMA administration and showed a constantly increasing signal ...