Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2019
CompletedResults Posted
Study results publicly available
January 31, 2020
CompletedJanuary 31, 2020
January 1, 2020
1.4 years
May 28, 2015
January 22, 2020
January 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
6 months
Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)
6 months
Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens
6 months
Other Outcomes (2)
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
Study Arms (1)
18F-DCFPyL PET/CT
EXPERIMENTALMen with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SKCCC
Baltimore, Maryland, 21287, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Steven Rowe, MD
- Organization
- Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
August 14, 2015
Study Start
June 2, 2015
Primary Completion
November 4, 2016
Study Completion
March 4, 2019
Last Updated
January 31, 2020
Results First Posted
January 31, 2020
Record last verified: 2020-01