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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01394 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues
Primary Objective:
Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ga-68 labeled PSMA-11 PET PSMA | Experimental | The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 labeled PSMA-11 | Drug | Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group | Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day |
| Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day |
| Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day |
| Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day |
| Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. |
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Inclusion Criteria:
Male, age >= 18.
Histopathologically proven prostate adenocarcinoma.
Concern for metastatic disease in one of the following settings:
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ga-68 Labeled PSMA-11 PET PSMA | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ga-68 Labeled PSMA-11 PET PSMA | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| 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 |
| 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 | Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group | Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | The Number Analyzed for each Row indicates the number of participants with each detected level of PSA | Posted | Number | proportion | 1 day |
|
Up to 1 day
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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 | Ga-68 Labeled PSMA-11 PET PSMA | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Hope, MD | University of California, San Francisco | (415) 221-4810 | Thomas.Hope@ucsf.edu |
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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 | Nov 26, 2019 | May 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| Positron emission tomography-computed tomography (PET/CT) | Device | Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session |
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| Positron emission tomography-magnetic resonance imaging (PET/MRI) | Device | A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session |
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| 1 day |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| 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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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | The Number Analyzed for each Row indicates the number of participants with each detected level of PSA | Posted | Number | proportion | 1 day |
|
|
|
| Primary | Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | The Number Analyzed for each Row indicates the number of participants with each detected level of PSA | Posted | Number | proportion | 1 day |
|
|
|
| Primary | Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | The Number Analyzed for each Row indicates the number of participants with each detected level of PSA | Posted | Number | proportion | 1 day |
|
|
|
| Primary | Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | The Number Analyzed for each Row indicates the number of participants with each detected level of PSA | Posted | Number | proportion | 1 day |
|
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| 0 |
| 485 |
| 0 |
| 485 |
| 0 |
| 485 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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| PSA Level of 0.5 to 0.99 |
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| PSA Level of 1 to 1.99 |
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| PSA Level of 2 to 4.99 |
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| PSA Level of 5 to maximum |
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| PSA Level of 0.5 to 0.99 |
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| PSA Level of 1 to 1.99 |
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| PSA Level of 2 to 4.99 |
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| PSA Level of 5 to maximum |
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| PSA Level of 0.5 to 0.99 |
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| PSA Level of 1 to 1.99 |
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| PSA Level of 2 to 4.99 |
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| PSA Level of 5 to maximum |
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| PSA Level of 0.5 to 0.99 |
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| PSA Level of 1 to 1.99 |
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| PSA Level of 2 to 4.99 |
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| PSA Level of 5 to maximum |
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