Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03824275

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Treatment and study plan

18F- DCFPyL PET/CT

Drug

A CT scan using a radioactive marker to better image tumors

Other names: CT scan

Primary outcomes

  1. To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis

    Time frame: 3.5 years

    To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis

Secondary outcomes

  1. To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones

    Time frame: 3.5 years

    To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis

  2. To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis

    Time frame: 3.5 years

    To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis

Other outcomes

  1. To characterize ctDNA and exosomes in patients with prostate cancer

    Time frame: 3.5 years

    To characterize ctDNA and exosomes in patients with prostate cancer

  2. To determine correlation with ctDNA and/or exosome levels with disease burden

    Time frame: 3.5 years

    To determine correlation with ctDNA and/or exosome levels with disease burden

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jan 31, 2019
Registry last updated
May 11, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.