Actively Recruiting
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
Led by MidLantic Urology · Updated on 2024-05-24
113
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
M
MidLantic Urology
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study Title: Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management Protocol number: BED-IIT-437 Phase: 3b Sponsor: MidLantic Urology Funding Organization: Blue Earth Diagnostics Ltd Study Design: This is a Phase 3b, multi-center, single-arm, diagnostic imaging study designed to detect metastatic lesions in men diagnosed with high-risk prostate cancer.
CONDITIONS
Official Title
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide signed informed consent and comply with all study schedule events where safe and feasible
- Male patients aged over 18 years
- Histologically confirmed adenocarcinoma of the prostate
- High-risk prostate cancer defined by any of the following: primary Gleason grade 4, any Gleason grade 5, PSA 20 or higher, or clinical stage T3a (per NCCN Guidelines Version 2.2019; PROS-2)
You will not qualify if you...
- Any medical condition or circumstance that may compromise study data or prevent fulfilling study requirements
- Planned use of x-ray contrast agent or other PET radiotracer within 24 hours before the PET scan
- Current or prior treatment with androgen deprivation therapy, including surgical orchidectomy, LHRH agonists/antagonists, or first/second generation anti-androgens
- Participation in an interventional clinical trial within 30 days and receipt of investigational product within five biological half-lives before rhPSMA-7.3 administration
AI-Screening
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Trial Site Locations
Total: 1 location
1
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
Research Team
C
Cheryl Zinar, RN,BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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