Copper PET Imaging for Recurrent Prostate Cancer

(Solar-Recur Trial)

Recruiting at 31 trial locations

Overseen By Darcy Denner, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Curium US LLC

Must not be taking: Androgen deprivation

Disqualifiers: Interventional trial, Hypersensitivity, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

235 Participants Needed

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 recurrent prostate cancer after radical prostatectomy or radiation therapy.

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 androgen deprivation therapy (ADT) or similar treatments in the past 3 months. 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 recurrent prostate cancer?

Research shows that Copper Cu 64 PSMA PET/CT imaging has a high potential for detecting prostate cancer, especially in cases of recurrent disease. It has demonstrated promising results in identifying cancer spread and offers high sensitivity for detecting local recurrence and lymph nodes. ^{1 2 3 4 5}

Is Copper Cu 64 PSMA I&T safe for use in humans?

Research on Copper Cu 64 PSMA I&T and similar compounds shows they are generally stable in the body and have been used safely in imaging studies for prostate cancer. However, high uptake in the kidneys and liver has been observed, which suggests careful monitoring is needed to ensure safety. ^{1 2 6 7 8}

What makes Copper Cu 64 PSMA I&T unique for imaging recurrent prostate cancer?

Copper Cu 64 PSMA I&T is unique because it uses a copper isotope (Copper-64) for PET imaging, which provides high spatial resolution and better detection of small lesions due to its shorter positron range. This imaging method also allows for late acquisitions with a higher target-to-background ratio, making it particularly effective for visualizing prostate cancer. ^{1 2 5 7 8}

Eligibility Criteria

This trial is for men over 18 who've had prostate cancer treated with surgery or radiation but now suspect it's come back. They need a confirmed rise in PSA levels after treatment and must understand and sign consent.

Inclusion Criteria

Able to understand and provide signed written informed consent

I am a man aged 18 or older.

My prostate cancer has returned, shown by rising PSA levels.

Exclusion Criteria

Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants receive an 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 imaging results are analyzed

72 hours

Treatment Details

Interventions

• Copper Cu 64 PSMA I&T

Trial Overview The study is testing Copper Cu 64 PSMA I&T, an injectable used in PET/CT scans to detect recurrent prostate cancer. It's a Phase 3 trial, meaning they're closer to confirming how well this works and its safety.

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]

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 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. Iran pubmed.ncbi.nlm.nih.gov

Soft tissue metastasis of the penis detected by copper-64 labeled prostate-specific membrane antigen positron emission tomography (64Cu-PSMA PET/CT) in a patient with prostate cancer. [2021]

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

64CuCl2 PET/CT as a potential new imaging method in prostate cancer: illusion or reality? [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

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

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]