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Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

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ClinicalTrials.gov Identifier: NCT03585114
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Emerson Lim, Columbia University

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE December 11, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS) [ Time Frame: Baseline, Post-treatment (approximately 6 weeks) ]
To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03585114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS) [ Time Frame: Baseline, Post-treatment (approximately 6 weeks) ]
    The percent difference in summed SUV between the first and second PET/CT will be noted.
  • Prevalence of baseline SUVmax correlating with rPFS [ Time Frame: Baseline, Post-treatment (approximately 6 weeks) ]
    To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation.
  • Change in number of lesions detected with standard imaging at baseline and at the time of progression [ Time Frame: Baseline, up to 1 year ]
    To compare lesions detected with standard imaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
Official Title  ICMJE Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
Brief Summary

Primary Objective:

  • To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.

Secondary Objectives:

  • To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS)
  • To determine whether baseline SUVmax correlate with rPFS
  • To compare number of lesions detected with standard imaging at baseline and at the time of progression
Detailed Description

Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.

PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Fifteen men will be recruited from Columbia University Medical Center.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Prostate Cancer
Intervention  ICMJE
  • Drug: [F-18] DCFPyL
    [18F]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of [18F]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).
    Other Name: [18F]DCFPyL (PyL)
  • Procedure: PET/CT imaging
    As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.
    Other Name: PET/CT acquisition
Study Arms  ICMJE Experimental: PyL-PET
Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive [F-18] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.
Interventions:
  • Drug: [F-18] DCFPyL
  • Procedure: PET/CT imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of prostate cancer
  • Age ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3
  • Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease
  • Ability to understand and willingness to sign a written informed consent document
  • Wiling to comply with clinical trial instructions and requirements

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
  • 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 Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal
  • Inadequate venous access
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ana Serra (212) 342-0248 as5713@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585114
Other Study ID Numbers  ICMJE AAAR6032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emerson Lim, Columbia University
Study Sponsor  ICMJE Emerson Lim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emerson Lim, MD Columbia University
PRS Account Columbia University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP