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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PSA > 0.2 ng/ml following Radical Prostatectomy | Experimental | Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive PCa Screens at Baseline | This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the baseline rhPSMA-7.3 (18F) scan. | Baseline |
| Positive PCa Screens at Second Scan Visit | This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the second rhPSMA-7.3 (18F) scan. | Up to Month 24 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert Lepor, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Comprehensive Prostate Cancer Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With PSA > 0.2 ng/ml Following Radical Prostatectomy | Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator. 18F-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. PET 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2024 |
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| PET MRI Imaging | Device | rhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time within one year of the initial scan. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With PSA > 0.2 ng/ml Following Radical Prostatectomy | Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator. 18F-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. PET 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive PCa Screens at Baseline | This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the baseline rhPSMA-7.3 (18F) scan. | A total of 24 participants underwent baseline imaging and were included in the baseline analysis. | Posted | Count of Participants | Participants | Baseline |
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| Primary | Positive PCa Screens at Second Scan Visit | This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the second rhPSMA-7.3 (18F) scan. | A total of 15 participants completed the second imaging assessment and were included in the second scan analysis. Participants without follow-up imaging were not included in the second scan analysis. | Posted | Count of Participants | Participants | Up to Month 24 |
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During and 30 minutes post-PET MRI (1 Baseline Visit, 1 second scan visit at Month 24)
Systematic assessment: PET MRI technician through a standard questionnaire and assessing their blood pressure before and after the scan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With PSA > 0.2 ng/ml Following Radical Prostatectomy | Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator. 18F-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. PET 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Majlinda Tafa, MD | NYU Langone Health | (646) 825-6338 | Majlinda.Tafa@nyulangone.org |
| Mar 4, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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