Research Topic: Prostate Cancer
Study Title: A single arm, multicenter, prospective, open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer
Research Team:
Hao Nguyen, MD, PhD, Principal Investigator (PI)
An Phan Nguyen, Clinical Research Coordinator
Sponsor: Telix Pharmaceuticals
Study Overview
The study is testing whether combining advanced imaging can detect prostate cancer more accurately than standard methods. The researchers want to evaluate how safe and effective this imaging approach can be in guiding informed biopsy decisions.
Participants receive advanced imaging that combines MRI and PSMA PET, which may provide a more detailed view of the prostate than standard approaches. Imaging results may help doctors better target biopsies to areas of concern, improving diagnostic precision. Participants are closely monitored throughout the study, with follow-ups to support safety and care.
Who can join?
- Age range: 18+
- Have elevated PSA and/or suspected prostate cancer
- Men being evaluated for possible prostate cancer with imaging, biomarker, and/or family/genetic risk factors
- Provides consent for clinical prostate biopsy
- Willing to comply with study procedures and requirements
- Agrees to comply with radiation protection rules
- Agrees to practice adequate precautions to prevent pregnancy in a female partner
- Prior cancer diagnosis (except for nonmelanoma skin cancers)
- Prior prostate biopsy
- MRI finding of “very high risk” of clinically significant prostate cancer (PI-RADS score of 5)
- Active prostate infection and/or urinary tract infection within 4 weeks
- Known allergy to the study agent and/or condition that would make study procedures unsafe (as determined by the study doctor)
- Is participating in any experimental drug or device study trial
What to Expect During the Study
Medical history and medication review, physical exam, vital signs, blood draw, IV injection of the imaging agent, PET/MRI scan, follow-up visits, and/or collection of surgical and medical record information.
In person only
UCSF Mission Bay campus
UCSF China Basin
- Participation in this study will help researchers improve how prostate cancer is detected and diagnosed.
- Participation may help advance more accurate imaging techniques, support better treatment decisions, reduce unnecessary biopsies and procedures, and improve care for future patients.
FAQ's
Approximately 6 months with about 3-5 study visits.
Participants complete screening, an imaging visit with MRI and PET scan, biopsy procedures, a short-term follow-up visit, and/or a longer-term follow-up up to 6 months.
Yes, participants may receive $100 for each completed visit.
About 20 participants at UCSF (approximately 338 total across all sites in the US and Australia).
Contact us
An Nguyen, Clinical Research Coordinator
[email protected]
(510) 545-9040