N/A
N=31
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Adenocarcinoma of the Prostate
Bottom Line
View on ClinicalTrials.gov: NCT02523924 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT — 21; 5; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 18F-DCFPyL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT |
21; 5; 5 | — |
| PRIMARY Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT |
8; 14; 2; 2; 0 | — |
| SECONDARY Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels |
13; 8 | — |
| SECONDARY Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) |
— | — |
| SECONDARY Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens |
— | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02523924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.