Copper PET Imaging for Recurrent Prostate Cancer

(Solar-Recur Trial)

No longer recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a special imaging method using Copper Cu 64 PSMA I&T to detect prostate cancer that has returned after surgery or radiation. It works like taking a clearer picture to determine if the cancer has come back. The trial seeks men who have previously had prostate cancer, received surgery or radiation, and now have rising PSA levels (a protein in the blood that can indicate cancer). This research could lead to improved methods for locating and managing recurrent prostate cancer. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potential breakthrough in prostate cancer detection.

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 prior data suggests that this imaging technique is safe for patients with recurrent prostate cancer?

Research has shown that Copper Cu 64 PSMA I&T underwent safety testing in earlier clinical trials. Participants generally tolerated the treatment well. Side effects were minimal and mostly mild, such as nausea or headache, which are common with many treatments. Importantly, no severe or life-threatening reactions occurred.

As this treatment is now in a late stage of clinical trials, extensive safety information is available. This can reassure prospective participants, as it suggests the treatment has been deemed safe enough for testing in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Copper Cu 64 PSMA I&T because it offers a new way to detect recurrent prostate cancer using advanced imaging technology. Unlike traditional imaging methods, this technique uses a radioactive copper isotope that specifically targets prostate-specific membrane antigen (PSMA) found on prostate cancer cells. This targeted approach allows for more precise imaging and could potentially lead to earlier and more accurate detection of cancer recurrence. By improving diagnostic accuracy, this method could significantly enhance treatment planning and outcomes for patients.

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

Research shows that Copper Cu 64 PSMA I&T, used in this trial for diagnostic imaging, effectively detects recurrent prostate cancer. Earlier studies demonstrated its success in identifying cancer spread and accurately pinpointing its location. It remains stable in the body longer than similar tools, offering greater reliability for doctors. Additionally, it clearly identifies cancer spread to the lymph nodes. This imaging tool holds promise for aiding doctors in making informed prostate cancer treatment decisions. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

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

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]

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]

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]

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05653856

Study Details | NCT05653856 | Cu-64-PSMA-I&T Positron ... This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent metastatic prostate ...

3. urologytimes.com urologytimes.com/view/trial-of-copper-cu-64-psma-i-t-pet-ct-imaging-in-prostate-cancer-meets-primary-end-points

Trial of Copper Cu 64 PSMA I&T PET/CT imaging in ... Specifically, copper Cu 64 PSMA I&T injection achieved the co-primary efficacy end points of region-level correct localization rate and patient- ...

4. 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 ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-use-of-64cu-psma-it-to-detect-lymph-node-spread-in-men-with-newly-diagnosed-prostate-cancer-before-surgery/

Study on the Use of 64Cu-PSMA I&T to Detect Lymph ... Copper Cu 64 PSMA I&T is a special imaging agent used in PET/CT scans. It helps doctors see if prostate cancer has spread to the pelvic lymph ...

6. 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 ...

7. 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 ...

8. onclive.com onclive.com/view/copper-64-psma-i-t-meets-coprimary-end-points-of-solar-trial-in-metastatic-prostate-cancer

Copper 64 PSMA I&T Meets Coprimary End Points of ... The trial evaluated the safety, biodistribution, and image quality of the radiolabeled receptor-targeted diagnostic Copper Cu 64 PSMA I&T to identify ...