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This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Prostate Cancer Arm | Experimental | [68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]PSMA-PET/MRI or PET/CT | Drug | [68Ga]PSMA-PET/MRI or PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI | 1 scan |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI | 1 scan | |
| Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered | 1 simulation scan | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35249 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic Prostate Cancer Arm | [68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer [68Ga]PSMA-PET/MRI or PET/CT: [68Ga]PSMA-PET/MRI or PET/CT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metastatic Prostate Cancer Arm | [68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer [68Ga]PSMA-PET/MRI or PET/CT: [68Ga]PSMA-PET/MRI or PET/CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI | Posted | Count of Participants | Participants | 1 scan |
|
|
18 months
Standard CTCAE assessment during radiation therapy
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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 | Metastatic Prostate Cancer Arm | [68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer [68Ga]PSMA-PET/MRI or PET/CT: [68Ga]PSMA-PET/MRI or PET/CT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| April Riddle | University of Alabama at Birmingham | (205)934-6504 | ariddle@uabmc.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 | Apr 15, 2021 | Jan 17, 2023 | 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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| Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities |
| 18 months |
| The Total Number of Pelvic Nodal Metastases Detected on MRI | 1 scan |
| 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 | Count of Participants | Participants |
|
|
| Secondary | The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI | Posted | Number | lymph nodes | 1 scan |
|
|
|
| Secondary | Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered | Posted | Count of Participants | Participants | 1 simulation scan |
|
|
|
| Secondary | Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | The Total Number of Pelvic Nodal Metastases Detected on MRI | Posted | Number | lymph nodes | 1 scan |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |