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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00092 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PROS0075 | Other Identifier | OnCore ID |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.
OBJECTIVES:
OUTLINE:
Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
After completion of study, patients are followed up at 24 to 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-PSMA PET/MRI | Experimental | Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-PSMA-11 | Drug | Undergo 68Ga-PSMA-11 PET/MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes | Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion. |
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INCLUSION CRITERIA
ExCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34406051 | Derived | Duan H, Baratto L, Hatami N, Liang T, Levin CS, Khalighi MM, Iagaru A. Reduced Acquisition Time per Bed Position for PET/MRI Using 68Ga-RM2 or 68Ga-PSMA-11 in Patients With Prostate Cancer: A Retrospective Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):333-340. doi: 10.2214/AJR.21.25961. Epub 2021 Aug 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 68Ga-PSMA PET/MRI | Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. 68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI |
| 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 | Aug 28, 2018 |
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| Magnetic resonance imaging (MRI) | Procedure | Undergo 68Ga-PSMA-11 PET/MRI |
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| Positron Emission Tomography (PET) | Procedure | Undergo 68Ga-PSMA-11 PET/MRI |
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| 1 Day |
| Sensitivity of 68Ga-PSMA-11 PET/MRI | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion. | 1 Day |
| Specificity of 68Ga-PSMA-11 PET/MRI | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion. | 1 Day |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 68Ga-PSMA PET/MRI | Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. 68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI |
| 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, Categorical | Count of Participants | Participants |
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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 | 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion. | Posted | Count of Participants | Participants | 1 Day |
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| Secondary | Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes | Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion. | Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation. | Posted | Count of Participants | Participants | 1 Day |
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| Secondary | Sensitivity of 68Ga-PSMA-11 PET/MRI | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion. | Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation. | Posted | Number | Percentage of participants | 1 Day |
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| Secondary | Specificity of 68Ga-PSMA-11 PET/MRI | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion. | Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation. | Posted | Number | Percentage of participants | 1 Day |
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up to 72 hours
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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 | 68Ga-PSMA PET/MRI | Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. 68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI | 0 | 74 | 0 | 74 | 0 | 74 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Otte | Stanford Medicine at Stanford University | 650-736-4183 | anotte@stanford.edu |
| Jan 6, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2020 | Mar 2, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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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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| Participants |
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| Participants |
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