Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
Purpose
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
Condition
- Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient is male and aged >18 years old. 2. Histologically confirmed adenocarcinoma of the prostate. 3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
Exclusion Criteria
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan. 2. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Positron Emission Tomography (PET) Imaging study
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patients |
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan |
|
More Details
- Status
- Completed
- Sponsor
- Blue Earth Diagnostics
Study Contact
Detailed Description
Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation [BIE]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.