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Cancer Imaging Agent

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of dose administration up to 72 hours

Awards & highlights

Solar-Stage Trial 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.Check my eligibility

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.See study design

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.

Solar-Stage 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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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.

Solar-Stage 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

Sensitivity

Specificity

Secondary outcome measures

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 outcome measures

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

Solar-Stage 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Curium US LLCLead Sponsor

5 Previous Clinical Trials

688 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 locations is this trial currently being conducted?

"Nine clinical sites, such as Tower Urology in Los Angeles, VA Greater Los Angeles Healthcare System in Newport Beach, and Hoag Memorial Hospital Presbyterian in Tampa, are currently enrolling participants."

Answered by AI

What is the current number of participants being enrolled in this research project?

"To conduct the research successfully, a total of 323 eligible individuals are required. The sponsor, Curium US LLC, will oversee the trial at various locations such as Tower Urology in Los Angeles, California and VA Greater Los Angeles Healthcare System in Newport Beach, Florida."

Answered by AI

What are the risks associated with Diagnostic Imaging using Copper Cu 64 PSMA I&T for individuals?

"Power's evaluation of the safety level for Diagnostic Imaging using Copper Cu 64 PSMA I&T is rated as a 3, reflecting the extensive data on both efficacy and safety gathered through Phase 3 investigations."

Answered by AI

Are there ongoing efforts to actively enroll participants for this clinical trial?

"According to the details available on clinicaltrials.gov, patient enrollment is currently ongoing for this investigation. The trial was first listed on 4/1/2024 and last revised on 4/23/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

2024. "Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235151.

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