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Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT02523924
Recruitment Status : Completed
First Posted : August 14, 2015
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE May 28, 2015
First Posted Date  ICMJE August 14, 2015
Results First Submitted Date  ICMJE January 22, 2020
Results First Posted Date  ICMJE January 31, 2020
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE June 2, 2015
Actual Primary Completion Date November 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT [ Time Frame: 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 [ Time Frame: 6 months ]
    Location of uptake of 18F-DCFPyL consistent with prostate cancer.
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
Description of putative sites of metastatic disease as determined by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels [ Time Frame: 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.
  • Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) [ Time Frame: 6 months ]
    Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
  • Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens [ Time Frame: 6 months ]
    Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
  • Assessment of treatment response by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]
  • Correlation of 18F-DCFPyL PET/CT findings with PSA levels and time to disease progression [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures
 (submitted: January 22, 2020)
  • 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Official Title  ICMJE Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Adenocarcinoma of the Prostate
Intervention  ICMJE Drug: 18F-DCFPyL
18F-DCFPyL PET/CT
Study Arms  ICMJE Experimental: 18F-DCFPyL PET/CT
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
Intervention: Drug: 18F-DCFPyL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2015)
20
Actual Study Completion Date  ICMJE March 4, 2019
Actual Primary Completion Date November 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02523924
Other Study ID Numbers  ICMJE J1545
IRB00062296 ( Other Identifier: JHMIRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP