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Completed

NCT Number: NCT02523924

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

SKCCC

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

18F-DCFPyl

Drug

18F-DCFPyL PET/CT

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Aug 14, 2015
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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