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

Last updated: May 6, 2022
Sponsor: Columbia University
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Prostate Cancer, Early, Recurrent

Urologic Cancer

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT03824275
AAAS1862
  • Ages > 18
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed diagnosis of prostate cancer
  2. PSA ≥ 0.2ng/ml
  3. Age ≥ 18 years of age
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)
  5. Ability to understand and willingness to sign a written informed consent document
  6. Wiling to comply with clinical trial instructions and requirements
  7. Willing to cover the cost of PyL PET/CT imaging if funds are not available

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 129
Study Start date:
February 12, 2019
Estimated Completion Date:
December 31, 2023

Study Description

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.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

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