An interventional study of 18F-DCFPyL in Adenocarcinoma of the Prostate, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-01-31.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Diagnostic
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's enrollment of 50 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
Drug: 18F-DCFPyL
18F-DCFPyL PET/CT
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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 6 months
Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression
Time frame: 6 months
Assessment of Treatment Response by 18F-DCFPyL PET/CT
Time frame: 6 months
| Milestone | 18F-DCFPyL PET/CT |
|---|---|
| Started | 31 |
| Completed | 31 |
| Not completed | 0 |
Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
| Participants | 18F-DCFPyL PET/CT |
|---|---|
| at least 1 site | 21 |
| > 1 site | 5 |
| no sites | 5 |
Location of uptake of 18F-DCFPyL consistent with prostate cancer.
| Participants | 18F-DCFPyL PET/CT |
|---|---|
| Prostate bed | 8 |
| Pelvic lymph node | 14 |
| Nonpelvic lymph node | 2 |
| Bone | 2 |
| Viscera | 0 |
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.
| Participants | 18F-DCFPyL PET/CT |
|---|---|
| PSA 0.2-1.0 ng/mL | 13 |
| PSA >1.0 ng/mL | 8 |
Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
No measurements were reported for this outcome.
Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
No measurements were reported for this outcome.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 18F-DCFPyL PET/CT | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | 18F-DCFPyL PET/CT |
|---|---|
| Median | 63 (45 to 74) |
| Sex: Female, Male(Participants) | 18F-DCFPyL PET/CT |
|---|---|
| Female | 0 |
| Male | 31 |
| Race (NIH/OMB)(Participants) | 18F-DCFPyL PET/CT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| Region of Enrollment(Participants) | 18F-DCFPyL PET/CT |
|---|---|
| United States | 31 |
| Months since radical prostatectomy(months) | 18F-DCFPyL PET/CT |
|---|---|
| Median | 30 (4 to 152) |
| Gleason grade group(Participants) | 18F-DCFPyL PET/CT |
|---|---|
| 1 | 2 |
| 2 | 6 |
| 3 | 13 |
| 4 | 1 |
| 5 | 9 |
| Pathologic stage(Participants) | 18F-DCFPyL PET/CT |
|---|---|
| pT2 | 11 |
| pT3a | 14 |
| pT3b | 6 |
| Positive surgical margin(Participants) | 18F-DCFPyL PET/CT |
|---|---|
| Count of participants | 13 |
1 further baseline measures are reported on the registry.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins