Enrollment Status: Currently enrolling participants.
Research Topic: Prostate cancer
Department/Division: Urology
Location: San Francisco, CA
Study Title: A Phase 3, Multi-center, Open-label, Study to Test the Diagnostic Performance of CopperCu64 PSMA I&TPET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection
Study Overview: Solar-Stage is a single-arm prospective study. Treating physicians will not be blinded to the imaging results. Local read of the copper Cu 64 PSMA I&T PET/CT can be used to inform patient management. For the co-primary endpoints, PET/CT scans will be read by blinded independent reviewers.
Research Team:
Hao Nguyen, MD, PhD, Principal Investigator (PI)
Imelda Tenggara, Director, Research Resources
An Phan Nguyen, Clinical Research Coordinator
Jason Goodloe, Clinical Research Coordinator
Sponsor: Curium, LLC
About this study
This study includes people who have recently been diagnosed with higher-risk prostate cancer and are planning to have surgery to remove the prostate and nearby lymph nodes.
Before surgery, each participant will receive a small amount of a radioactive tracer (called copper Cu 64 PSMA I&T) through an IV. They will then have a PET/CT scan a few hours later.
The scan images will be reviewed by three independent experts who do not have access to the patients’ medical information. The goal is to see whether the scan can find signs of prostate cancer in lymph nodes and other parts of the body.
Purpose of this study
The purpose of this study is to find out how accurate this new PET/CT scan is at detecting the spread of prostate cancer, especially to lymph nodes and other areas like bones or organs.
Researchers will compare the scan results to lab results from tissue removed during surgery (the most reliable way to confirm cancer) to see how well the scan performs.
Why this study is important
If this imaging method proves to be accurate, it could:
- Help doctors detect cancer spread earlier
- Improve treatment decisions
- Potentially reduce unnecessary procedures
- Lead to better outcomes for patients
In short, this study is testing whether a new type of scan can give doctors clearer, more reliable information about prostate cancer before surgery.
Who can join?
You're eligible if...
- Are 18 years or older.
- Have been diagnosed with prostate cancer.
- Completed treatment.
- Can read English or Spanish.
You're not eligible if...
- Have had androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against prostate cancer prior to RP
- PSMA PET within 90 days prior to enrollment
Who should participants contact for more information?
[email protected]
Learn more about SOLAR STAGE Clinical Trials at the Curium clinical trial webpage