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Cancer Imaging Agent

Copper PET Imaging for Recurrent Prostate Cancer (Solar-Recur 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
Recurrence of disease defined as: PSA greater than 0.2 ng/mL followed by subsequent confirmatory PSA value greater than 0.2 ng/mL (for prior radical prostatectomy) or 2 ng/mL rise in PSA over post-treatment nadir (for prior radiation therapy)
Must not have
Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of dose administration up to 72 hours
Awards & highlights

Summary

This trial is testing a new imaging technique using a radioactive substance called copper Cu 64 PSMA I&T injection to detect recurrent prostate cancer in patients who have previously undergone surgery or radiation therapy for prostate cancer

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves imaging rather than medication, side effects are minimal but may include discomfort from the injection or allergic reactions to the tracer used in the PET/CT scan.

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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My prostate cancer has returned, shown by rising PSA levels.
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I have been diagnosed with prostate cancer through a tissue test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not scheduled for an x-ray contrast or PET radiotracer before my PET scan.
Select...
I haven't had high-energy radioisotope treatments recently.

Timeline

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
Patient-Level Correct Detection Rate (CDR)
Region-Level Correct Localization Rate (CLR)
Secondary study objectives
CDR and CLR by Prostate-Specific Antigen level
CDR and CLR by histopathology available and histopathology unavailable
Incidence of adverse events of copper Cu 64 PSMA I&T injection
+1 more

Side effects data

From 2020 Phase 4 trial • 711 Patients • NCT02175030
5%
Adverse events experienced related to IUD at 1-Month
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Curium US LLCLead Sponsor
5 Previous Clinical Trials
811 Total Patients Enrolled
~120 spots leftby Jul 2025
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