Research Topic: Prostate Cancer
Study Title: A Phase 3, Multi-center, Open-label, Study to Test the Diagnostic Performance of CopperCu64 PSMA I&T PET/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
Research Team:
Hao Nguyen, MD, PhD, Principal Investigator (PI)
An Phan Nguyen, Clinical Research Coordinator
Sponsor: Curium, LLC
Study Overview
The study is testing whether an investigational imaging medicine, Copper 64 PSMA I&T, can help show prostate cancer tumors more clearly on PET/CT scans.
The researchers want to learn how safe and effective the scan is for staging newly diagnosed intermediate-risk, high-risk, or very high-risk prostate cancer. The study is also looking at whether the scan pictures can help doctors correctly stage the cancer before surgery.
Participants will receive a specialized PET/CT scan using an investigational imaging agent designed to help doctors better see prostate cancer in the body. This study focuses on improving how prostate cancer is staged before surgery, which is an important step in choosing the best treatment plan. The imaging may provide more detailed information about whether cancer has spread, helping guide clinical decisions. Study involvement is relatively short, with only a few visits over a brief period and a follow-up phone call. Participants are closely monitored throughout the study to support safety and care.
Who can join?
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What to Expect During the Study
Medical history and medication review, physical exam, vital signs, blood draw, IV injection of the imaging agent, PET/CT scan, a follow-up phone call, and/or collection of surgical and medical record information.
In person and remote
Mission Bay campus
China Basin
- Participation helps doctors learn whether this new imaging test is accurate enough to support better informed staging of prostate cancer before active treatment and care.
- Participation may contribute to the development and approval of more effective diagnostic imaging tools for future patients.
FAQ's
About 4-5 hours of active participation, with medical record follow-up up to 90 days.
There is a screening visit, an imaging day visit, and a follow-up phone call about 3-5 days later. The imaging day may take up to 4 hours, and the phone follow-up may take up to 30 minutes.
Yes, for each completed visit, participants may receive $200 for the screening visit and $200 for dosing/imaging, for a total of $400 in this study. They may also be reimbursed for travel costs as well.
About 40 at UCSF, and about 439 total across approximately 45 US sites