Copper PET Imaging for Prostate Cancer

(Solar-Stage Trial)

Recruiting at36 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Curium US LLC

Must not be taking: Androgen deprivation, Chemotherapy

Disqualifiers: Interventional trial, Hypersensitivity, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had certain prostate cancer treatments or investigational therapies before joining. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Copper Cu 64 PSMA I&T for prostate cancer?

Research shows that Copper Cu 64 PSMA, used in PET imaging, has a high potential for diagnosing prostate cancer, especially in detecting recurrent disease and advanced local disease. It provides high spatial resolution and better detection of small lesions, making it effective for imaging both primary tumors and metastases. ^{1 2 3 4 5}

Is Copper PET Imaging for Prostate Cancer safe for humans?

Research on Copper PET Imaging, specifically using Copper Cu 64 PSMA I&T, shows that it is generally stable in the body and has been tested in mice with promising results for targeting prostate cancer. However, high uptake in the kidneys and liver was observed, which may require monitoring in human trials. ^{1 4 6 7 8}

What makes the drug Copper Cu 64 PSMA I&T unique for prostate cancer treatment?

Copper Cu 64 PSMA I&T is unique because it uses a copper isotope for PET imaging, which provides high spatial resolution and better detection of small lesions in prostate cancer. This drug also allows for late imaging with a higher target-to-background ratio, making it effective for both diagnosis and therapy planning. ^{1 2 4 6 8}

Research Team

Eligibility Criteria

Men over 18 with newly diagnosed, high-risk prostate cancer who are planning to undergo prostatectomy and lymph node dissection. They must have a confirmed diagnosis of prostate adenocarcinoma and understand the study enough to give informed consent.

Inclusion Criteria

I am a man aged 18 or older.

My condition is classified as intermediate to very high risk according to NCCN guidelines.

I am scheduled for prostate surgery with lymph node removal.

Exclusion Criteria

Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment

Patients with known hypersensitivity to the active substance or any of the excipients of the IP

I haven't been in a drug study or taken any experimental drugs recently.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants receive an 8 mCi intravenous dose of copper Cu 64 PSMA I&T injection followed by PET/CT imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and diagnostic performance is assessed

72 hours

Treatment Details

Interventions

• Copper Cu 64 PSMA I&T (Cancer Imaging Agent)

Trial Overview The trial is testing Copper Cu 64 PSMA I&T injection for PET/CT imaging in men with new, unfavorable intermediate to very high-risk prostate cancer. It's an open-label Phase 3 study, meaning everyone knows what treatment they're getting.

Participant Groups

Group I: Diagnostic Imaging with Copper Cu 64 PSMA I&T Experimental Treatment 1 Intervention

Copper Cu 64 PSMA I\&T Injection

Who Is Running the Clinical Trial?

Curium US LLC

Lead Sponsor

Trials

6

Recruited

1,000+

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]

In a study involving 16 men with prostate cancer, 64 Cu-labeled PSMA-617-PET/CT imaging was found to be effective for detecting both primary tumors and metastases, demonstrating its feasibility for prostate cancer imaging.

However, comparing early (2 hours) and late (22 hours) scans revealed no significant clinical advantage of later imaging, suggesting that the additional time and resources may not be justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-time-point 64 Cu-PSMA-617-PET/CT in patients suffering from prostate cancer. Hoberück, S., Wunderlich, G., Michler, E., et al.[2021]

High levels of copper are associated with prostate cancer, making copper a promising target for PET imaging in detecting this type of cancer.

Using Copper-64 (64Cu) for PET imaging, especially when combined with prostate-specific membrane antigen (PSMA), enhances the ability to identify small lesions due to its high spatial resolution and improved target-to-background ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Copper, PET/CT and prostate cancer: a systematic review of the literature. Piccardo, A., Ugolini, M., Righi, S., et al.[2023]

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]

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 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 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. England pubmed.ncbi.nlm.nih.gov

Dual-time-point 64 Cu-PSMA-617-PET/CT in patients suffering from prostate cancer. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Copper, PET/CT and prostate cancer: a systematic review of the literature. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of 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

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

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

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