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Trial Title:
Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy
NCT ID:
NCT05678322
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent
Description:
Under development for the diagnosis of prostate cancer by Blue Earth Diagnostics.
rhPSMA-7.3 (18F) will be administered intravenously as a single-dose injection. The
molecular structure of the drug substance comprises a prostate-specific membrane antigen
(PSMA) binding motif, a peptide spacer, an 18F-radiolabeled silicon fluoride acceptor
moiety and a gallium chelator complex.
Arm group label:
Patients with PSA > 0.2 ng/ml following Radical Prostatectomy
Other name:
rhPSMA-7.3 (18F)
Intervention type:
Device
Intervention name:
PET MRI Imaging
Description:
rhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time
within one year of the initial scan.
Arm group label:
Patients with PSA > 0.2 ng/ml following Radical Prostatectomy
Summary:
All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine
prostate specific antigen (PSA) testing in order to identify disease recurrence. By
consensus, a BCR following RP occurs once the PSA > 0.2 ng/ml/ Biochemical recurrence
often develops years prior to clinical evidence of disease recurrence. Early
identification of the site(s) of disease recurrence enables early salvage intervention.
Men will be eligible for the study at the point in time their post-prostatectomy PSA
level first becomes >0.2 ng/ml. Only those patients with rhPSMA-7.3 (18F) identifiable
disease (local, nodal or systemic) will be offered salvage intervention per standard of
care. All patients with a negative initial rhPSMA-7.3 (18F) scan will undergo a second
scan when the PSA is > 0,5 ng/ml or one year after the initial PET study. The salvage
interventions will be at the discretion of the investigator. The study will compare the
diagnostic yield of the first and second rhPSMA-7.3 (18F) studies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Eligible patients will include all men between age 18 -100 years old,-that have had RP,
at the first point in time the PSA > 0.2 ng/ml.
Exclusion Criteria:
- Any contraindication for MRI imaging.
- Prior allergic reaction to rhPSMA-7.3 (18F).
- Patient refuses rhPSMA-7.3 (18F) PET/MRI.
Gender:
Male
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Smilow Comprehensive Prostate Cancer Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Herbert Lepor, MD
Phone:
646-825-6340
Email:
Herbert.lepor@nyulangone.org
Start date:
January 31, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Collaborator:
Agency:
Blue Earth Diagnostics
Agency class:
Industry
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05678322
