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Cancer Imaging Agent

Copper PET Imaging for Prostate Cancer (Solar-Stage Trial)

Phase 3

Recruiting

Research Sponsored by Curium US LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male aged greater than or equal to 18 years

Planned prostatectomy with pelvic lymph node dissection

Must not have

Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&T administration

Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of dose administration up to 72 hours

Awards & highlights

Summary

This trial will test a new imaging technique using copper Cu 64 PSMA I&T injection in patients with newly diagnosed aggressive prostate cancer to see if it can help doctors better visualize the extent of the cancer

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Copper Cu 64 PSMA I&T are not detailed here but may include typical reactions from diagnostic imaging agents such as mild irritation at the injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

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I am scheduled for prostate surgery with lymph node removal.

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I have been diagnosed with prostate cancer through a biopsy.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had high-energy radiation treatment recently.

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I have not had hormone therapy, chemotherapy, radiation, or experimental treatments for prostate cancer before surgery.

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I am not scheduled for an x-ray contrast or PET radiotracer before my PET scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of dose administration up to 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of dose administration up to 72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of dose administration up to 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitivity

Specificity

Secondary study objectives

Incidence of adverse events in copper Cu 64 PSMA I&T injection

Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis

Other study objectives

Assess PPV of lesions on copper Cu 64 PSMA I&T PET/CT outside the prostate and pelvic lymph nodes (M1 disease)

Assess the detection rate on patient level and split by pelvic lymph nodes and extra pelvic lesions

Assess the impact of copper Cu 64 PSMA I&T PET/CT on the intended clinical management of study participants

+2 more

Side effects data

From 2020 Phase 4 trial • 711 Patients • NCT02175030

Adverse events experienced related to IUD at 1-Month

100%

80%

60%

40%

20%

Study treatment Arm

Copper T380 IUD

LNG20 IUD

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic Imaging with Copper Cu 64 PSMA I&TExperimental Treatment1 Intervention

Copper Cu 64 PSMA I\&T Injection

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Curium US LLCLead Sponsor

5 Previous Clinical Trials

688 Total Patients Enrolled

~194 spots leftby Jul 2025

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