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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00062296 | Other Identifier | JHMIRB |
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This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.
18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL PET/CT | Experimental | Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL | Drug | 18F-DCFPyL PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Number of sites with 18F-DCFPyL uptake consistent with prostate cancer. | 6 months |
| Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Location of uptake of 18F-DCFPyL consistent with prostate cancer. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels | Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer. | 6 months |
| Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression | 6 months | |
| Assessment of Treatment Response by 18F-DCFPyL PET/CT | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SKCCC | Baltimore | Maryland | 21287 | United States |
19 patients did not meet inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | 18F-DCFPyL PET/CT | Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 18F-DCFPyL PET/CT | Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Number of sites with 18F-DCFPyL uptake consistent with prostate cancer. | Posted | Count of Participants | Participants | 6 months |
|
|
6 months
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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 | 18F-DCFPyL PET/CT | Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Rowe, MD | Johns Hopkins University | 4105028052 | srowe8@jhmi.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 | Feb 21, 2017 | Jan 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging. |
| 6 months |
| Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens | Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression. | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Months since radical prostatectomy | Median | Full Range | months |
|
| Gleason grade group | The Gleason score ranges from 2-10 with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5) | Count of Participants | Participants |
|
| Pathologic stage | Count of Participants | Participants |
|
| Positive surgical margin | Count of Participants | Participants |
|
| Prostate Specific Antigen (PSA) | Median | Full Range | ng/mL |
|
|
| Primary | Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Location of uptake of 18F-DCFPyL consistent with prostate cancer. | Location of 18F-DCFPyL uptake could only be assessed in patients with at least 1 site of 18F-DCFPyL uptake (26/31) | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels | Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer. | Only 22/31 participants had a PSA of 0.2-1.0ng/mL and 9/31 participants had PSA >1.0ng/mL. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) | Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging. | Data was not collected for this outcome as participants did not have conventional imaging correlates. | Posted | 6 months |
|
|
| Secondary | Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens | Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression. | Data was not collected to assess this outcome measure as confirmatory biopsy was not practical to perform and histopathologic confirmation is not available. | Posted | 6 months |
|
|
| Other Pre-specified | Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression | Not Posted | 6 months | Participants |
| Other Pre-specified | Assessment of Treatment Response by 18F-DCFPyL PET/CT | Not Posted | 6 months | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| Bone |
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| Viscera |
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