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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Drug: 18F-DCFPyL Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Actual Study Start Date : June 2, 2015
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : March 4, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 18F-DCFPyL PET/CT
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
 Drug: 18F-DCFPyL
18F-DCFPyL PET/CT


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression [ Time Frame: 6 months ]
  2. Assessment of Treatment Response by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523924


Locations
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United States, Maryland
SKCCC
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Study Documents (Full-Text)

Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Study Protocol and Statistical Analysis Plan  [PDF] February 21, 2017

More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02523924    
Other Study ID Numbers: J1545
IRB00062296 ( Other Identifier: JHMIRB )
First Posted: August 14, 2015    Key Record Dates
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms