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Cancer Imaging Agent

Diagnostic imaging with Copper Cu 64 PSMA I&T for Prostate Adenocarcinoma (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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of dose administration up to 72 hours

Awards & highlights

Solar-Recur Trial 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.Check my eligibility

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.See study design

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.

Solar-Recur Trial 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.

Solar-Recur Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-Level Correct Detection Rate (CDR)

Region-Level Correct Localization Rate (CLR)

Secondary outcome measures

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

Adverse events experienced related to IUD at 1-Month

100%

80%

60%

40%

20%

Study treatment Arm

Copper T380 IUD

LNG20 IUD

Solar-Recur 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Curium US LLCLead Sponsor

5 Previous Clinical Trials

811 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct clinics is this experimental investigation currently being conducted?

"Eleven facilities, including XCancer in Omaha, Tower Urology in Newport Beach, and Hoag Memorial Hospital Presbyterian in Tampa, among others, are currently active sites for this clinical trial."

Answered by AI

Are patients currently being actively enrolled in this ongoing medical study?

"As per clinicaltrials.gov, this study is currently in the recruitment phase. The trial was first listed on 4/1/2024 and last revised on 4/23/2024."

Answered by AI

What is the total number of individuals currently enrolled in this medical study?

"A total of 200 eligible individuals are sought to enroll in this research endeavor. Potential participants have the opportunity to join from various locations, including XCancer located in Omaha, Nebraska and Tower Urology situated in Newport Beach, Florida."

Answered by AI

What are the potential risks associated with utilizing Copper Cu 64 PSMA I&T in diagnostic imaging procedures for individuals?

"Our team at Power has rated the safety of Diagnostic imaging with Copper Cu 64 PSMA I&T as a 3 on our scale. This rating aligns with it being in Phase 3, indicating existing efficacy data and robust safety records from multiple evaluations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

2024. "Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235099.

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