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

  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    Columbia University
Updated on 30 January 2021
ct scan
metastatic prostate cancer
pet/ct scan
prostate cancer metastatic


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.


The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT.

[18F]DCFPyL will be used for study imaging.

Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate tumor, prostate tumors
Treatment 18F- DCFPyL PET/CT
Clinical Study IdentifierNCT03824275
SponsorColumbia University
Last Modified on30 January 2021


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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Malignant neoplasm of prostate?
Do you have any of these conditions: prostate tumor or Prostate Cancer or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate or prostate tumors or Prostatic disorder or P...?
Histologically confirmed diagnosis of prostate cancer
PSA 0.2ng/ml
Age 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 2 (karnofsky 60%)
Ability to understand and willingness to sign a written informed consent document
Wiling to comply with clinical trial instructions and requirements
Willing to cover the cost of PyL PET/CT imaging if funds are not available

Exclusion Criteria

History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
Presence of prostate brachytherapy implants unless approved by the PI
Administration of another radioisotope within five physical half-lives of trial enrollment
Radiation or chemotherapy within 2 weeks prior to trial enrollment
Serum creatinine > 3 times the upper limit of normal
Serum total bilirubin > 3 times the upper limit of normal
Aspartate transaminase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal
Inadequate venous access
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