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18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 11, 2022 (before its estimated December 2022 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 300 to confirmed 129 · Study site revisedv5 Show 2 more changesShow less
    • Enrollment target: estimated 300 to confirmed 129
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv4
  3. Eligibility criteria expanded, about 10 wordsv3 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Dec 31, 2022 to Dec 2022 Completion date: Dec 31, 2022 to Dec 2023 · Start date changed from estimate of Feb 15, 2019 to Feb 12, 2019 · Study description shortened, about 294 words · 3 morev2 Show 6 more changesShow less
    • Completion date: Dec 31, 2022 to Dec 2023
    • Start date changed from estimate of Feb 15, 2019 to Feb 12, 2019
    • Study description shortened, about 294 words
    • Site contact updated
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, \[18F\] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of \[18F\] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.
Trial Details
NCT Number NCT03824275
Lead Sponsor Columbia University
Conditions Prostatic Neoplasms
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov