Prostate Cancer
Conditions
Brief 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.
Interventions
DRUG18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent
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.
DEVICEPET MRI Imaging
rhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time within one year of the initial scan.
Sponsors
NYU Langone Health
Blue Earth Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive PCa Screens at Baseline | Baseline | This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the baseline rhPSMA-7.3 (18F) scan. |
| Positive PCa Screens at Second Scan Visit | Up to Month 24 | This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the second rhPSMA-7.3 (18F) scan. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHerbert Lepor, MD
NYU Langone Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
None listed