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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-04135 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.
PRIMARY OBJECTIVE:
I. To overcome a clinical access issue that would otherwise block patients from reimbursement of a new cancer therapy, and therefore block or significantly delay their care.
OUTLINE:
Patients receive gallium Ga 68 gozetotide intravenously (IV) and then undergo a positron emission tomography (PET)/computed tomography (CT) scan throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (68Ga-PSMA-11 PET/CT) | Experimental | Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Reporting Adverse Reactions | Safety of gallium Ga 68 gozetotide [68Ga-prostate-specific membrane antigen (PSMA)-11] assessed by the number of patients reporting unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11. | From the time of injection until the time after imaging scan is complete, up to 1 day |
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Inclusion Criteria:
An adult male patient who is actively under the care of a medical oncology, radiation oncology or urology physician at Mayo Clinic
An adult male patient who is deemed eligible (or potentially/likely eligible) for PSMA-targeted radionuclide therapy by a nuclear medicine physician or Radiologist in the nuclear medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB)
An adult male patient who has not received a 68Ga-PSMA-11 PET/CT or PET/magnetic resonance (MR), or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure eligibility
An adult male patient who does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan
An adult above the ages of 18
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey B. Johnson, M.D., Ph.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational (68Ga-PSMA-11 PET/CT) | Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial. Computed Tomography: Undergo PET/CT scan Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT 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 | Yes | No | No | Study Protocol | Sep 22, 2022 | Jun 4, 2025 |
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| Gallium Ga 68 Gozetotide | Drug | Given IV |
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| Positron Emission Tomography | Procedure | Undergo PET/CT scan |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational (68Ga-PSMA-11 PET/CT) | Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial. Computed Tomography: Undergo PET/CT scan Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| 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 | Patients Reporting Adverse Reactions | Safety of gallium Ga 68 gozetotide [68Ga-prostate-specific membrane antigen (PSMA)-11] assessed by the number of patients reporting unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11. | Posted | Count of Participants | Participants | From the time of injection until the time after imaging scan is complete, up to 1 day |
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Patients were monitored for 24 hours after receiving injection/nuclear medicine scans
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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 | Observational (68Ga-PSMA-11 PET/CT) | Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial. Computed Tomography: Undergo PET/CT scan Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan | 0 | 156 | 0 | 156 | 0 | 156 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey Johnson, M.D., Ph.D. | Mayo Clinic | 507-284-4104 | johnson.geoffrey@mayo.edu |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2023 | Apr 2, 2025 | ICF_001.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 |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| C000622699 | 68Ga-DKFZ-PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 50-59 |
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| 60-69 |
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| 70-79 |
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| 80-89 |
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| 90-99 |
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