NCT06235151 · Curium US LLC
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
(Solar-Stage)
What this study is about
This is a forward-looking, where both patients and doctors know the treatment given Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
View original scientific description
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 unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with histologically proven prostate adenocarcinoma.
- Planned prostatectomy with pelvic lymph node dissection.
- Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
- Male aged greater than or equal to 18 years.
- Able to understand and provide signed written informed consent.
Exclusion criteria
- Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.
- Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.
- Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a
Where
- Homewood, Alabama
- Little Rock, Arkansas
- Fullerton, California
- Los Angeles, California
- Newport Beach, California
- Orange, California
- San Francisco, California
- Santa Monica, California
- Stanford, California
- Washington D.C., District of Columbia
- Miami, Florida
- Sarasota, Florida
And 27 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations