Adenocarcinoma of the Prostate
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUG18F-DCFPyL
18F-DCFPyL PET/CT
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * History of adenocarcinoma of the prostate treated with radical prostatectomy * Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment * Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment
Exclusion criteria
* Intention to enroll in a blinded therapeutic clinical trial * History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | 6 months | Number of sites with 18F-DCFPyL uptake consistent with prostate cancer. |
| Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | 6 months | Location of uptake of 18F-DCFPyL consistent with prostate cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens | 6 months | Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression. |
| Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) | 6 months | Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging. |
| Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels | 6 months | 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. |
Other
| Measure | 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 |
Countries
United States
Participant flow
Pre-assignment details
19 patients did not meet inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 18F-DCFPyL PET/CT Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
18F-DCFPyL: 18F-DCFPyL PET/CT | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | 18F-DCFPyL PET/CT |
|---|---|
| Age, Continuous | 63 years |
| Gleason grade group 1 | 2 Participants |
| Gleason grade group 2 | 6 Participants |
| Gleason grade group 3 | 13 Participants |
| Gleason grade group 4 | 1 Participants |
| Gleason grade group 5 | 9 Participants |
| Months since radical prostatectomy | 30 months |
| Pathologic stage pT2 | 11 Participants |
| Pathologic stage pT3a | 14 Participants |
| Pathologic stage pT3b | 6 Participants |
| Positive surgical margin | 13 Participants |
| Prostate Specific Antigen (PSA) | 0.4 ng/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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.
Time frame: 6 months
Population: Location of 18F-DCFPyL uptake could only be assessed in patients with at least 1 site of 18F-DCFPyL uptake (26/31)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 18F-DCFPyL PET/CT | Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Prostate bed | 8 Participants |
| 18F-DCFPyL PET/CT | Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Pelvic lymph node | 14 Participants |
| 18F-DCFPyL PET/CT | Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Nonpelvic lymph node | 2 Participants |
| 18F-DCFPyL PET/CT | Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Bone | 2 Participants |
| 18F-DCFPyL PET/CT | Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Viscera | 0 Participants |
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 18F-DCFPyL PET/CT | Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | at least 1 site | 21 Participants |
| 18F-DCFPyL PET/CT | Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | > 1 site | 5 Participants |
| 18F-DCFPyL PET/CT | Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | no sites | 5 Participants |
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.
Time frame: 6 months
Population: Only 22/31 participants had a PSA of 0.2-1.0ng/mL and 9/31 participants had PSA \>1.0ng/mL.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 18F-DCFPyL PET/CT | Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels | PSA 0.2-1.0 ng/mL | 13 Participants |
| 18F-DCFPyL PET/CT | Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels | PSA >1.0 ng/mL | 8 Participants |
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.
Time frame: 6 months
Population: Data was not collected for this outcome as participants did not have conventional imaging correlates.
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.
Time frame: 6 months
Population: Data was not collected to assess this outcome measure as confirmatory biopsy was not practical to perform and histopathologic confirmation is not available.
Other Pre-specified
Assessment of Treatment Response by 18F-DCFPyL PET/CT
Time frame: 6 months
Other Pre-specified
Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression
Time frame: 6 months