Copper PET Imaging for Prostate Cancer

(Solar-Stage Trial)

Recruiting at 37 trial locations

Overseen By Holly Karsch

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Curium US LLC

Must not be taking: Androgen deprivation, Chemotherapy

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

323 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique using Copper Cu 64 PSMA I&T to help doctors see prostate cancer more clearly. It focuses on men newly diagnosed with intermediate to very high-risk prostate cancer who plan to undergo surgery. Eligible participants should have confirmed prostate cancer and not have received any treatment for it yet. The goal is to improve scan accuracy to better guide treatment decisions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking advancement in prostate cancer imaging.

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 prior data suggests that Copper Cu 64 PSMA I&T is safe for PET/CT imaging?

Research has shown that Copper Cu 64 PSMA I&T is generally safe and well-tolerated. In studies with prostate cancer patients, this imaging agent has been used without major safety issues. These studies report no serious side effects directly linked to the treatment. The treatment uses a small amount of radioactive copper for PET/CT scans, enhancing the visibility of cancer. At this stage of research, treatments typically have a good safety record due to testing in earlier studies. While minor side effects might occur, previous research indicates an overall positive safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Copper Cu 64 PSMA I&T for prostate cancer because it offers a new way to image cancer cells. Unlike standard imaging techniques that might miss small clusters of cancer cells, this method uses a radioactive form of copper to target PSMA, a protein commonly found on prostate cancer cells, making it easier to detect the cancer's spread. This targeted approach could potentially lead to earlier detection and more accurate assessments of the cancer, which is crucial for effective treatment planning.

What evidence suggests that Copper Cu 64 PSMA I&T is effective for prostate cancer imaging?

Research has shown that Copper Cu 64 PSMA I&T effectively images prostate cancer. PSMA, a protein abundant on prostate cancer cells, binds with Copper Cu 64 PSMA I&T, enabling doctors to clearly visualize cancer cells on PET/CT scans. Studies indicate that this method provides clear and reliable images of prostate cancer, aiding in assessing the disease's spread and severity. This trial will employ this promising imaging technique for both newly diagnosed cases and recurrent cancer. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Copper Cu 64 PSMA I&T

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05653856

Study Details | NCT05653856 | Cu-64-PSMA-I&T Positron ... The study will include a group of 26 patients with metastatic prostate cancer. Each patient will be administered a 7-9 mCi intravenous dose of copper Cu 64 PSMA ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06235099

NCT06235099 | Copper Cu 64 PSMA I&T PET Imaging in ... 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 ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/early/2024/07/18/jnumed.123.267126.full.pdf

Cu-PSMA–Targeted PET for Prostate Cancer [61Cu]Cu-NODAGA-PSMA-I&T was significantly more stable in vivo at 1h after injection than [61Cu]Cu-DOTAGA-PSMA-. I&T, which showed approximately ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5435610/

Synthesis and evaluation of [64Cu]PSMA-617 targeted for ... We radiolabeled a ligand, PSMA-617, of prostate-specific membrane antigen (PSMA) with copper-64 (64Cu), to evaluate the metabolism, biodistribution, and ...

5. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15226.copper-cu-64-psma-i-t-pet-imaging-in-men-with-newly-diagnosed-prostate-cancer-solar-stage.html

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly ... 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 ...

6. stanfordhealthcare.org stanfordhealthcare.org/trials/c/NCT06235151.html

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly ... 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 ...

7. curiumpharma.com curiumpharma.com/2025/10/15/64cu-psma-japan/

Curium Group, PeptiDream and PDRadiopharma Enroll ... The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll ...

8. cancernetwork.com cancernetwork.com/view/evaluating-the-role-of-cu-psma-pet-imaging-in-prostate-cancer

Evaluating the Role of Cu-PSMA PET Imaging in Prostate ... Panelists discuss how, Copper-64 (^64Cu)–labeled PSMA-targeted PET imaging is emerging as a promising modality in prostate cancer diagnosis.