Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
MidLantic Urology
Summary
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.
Description
Consented patients will be screened to determine eligibility for the study prior to investigational product (IP) administration. In addition to their routine clinical work-up, which will include 99mtechnetium-biphosphonate bone scan and abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) and chest CT per local practice, and before the scheduled radical prostatectomy (RP) and pelvic lymph node dissection (PLND), or radical pelvic radiation therapy, patients will receive 8 mCi (296 MBq) ± 20% rhPSMA-7.3, delivered as an intravenous (IV) bolus injection, followed by PET…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible. 2. Patient is male and aged \>18 years old. 3. Histologically confirmed adenocarcinoma of the prostate. 4. High risk prostate cancer. High-risk patients will be defined as having any of the following criteria: primary Gleason grade 4, or any Gleason grade 5, PSA ≥20, or clinical stage T3a (per NCCN Guidelines Version 2.2019; PROS-2). Exclusion Criteria: 1. Patients with any medical condition or circumstance (including receiving an…
Interventions
- DrugrhPSMA-7.3 (18F)
Patients will receive a dose with an administered activity of 8 mCi (296 MBq) ± 20% of rhPSMA-7.3, delivered as an IV bolus injection with a 10 mL fast 0.9% sodium chloride flush, followed by PET imaging.
Location
- MidLantic UrologyBala-Cynwyd, Pennsylvania