Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181867
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE June 8, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE August 3, 2017
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
To assess the ability of 18FDCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer. [ Time Frame: 12 months ]
Correlation between 18F-DCFPyL scanning and accurately staging of high-risk primary prostate cancer and detection of sites of recurrent prostate cancer.
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
To assess the ability of 18FDCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer. [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT03181867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • Compare focal 18F-DCFPyL uptake with focal abnormalities identified on standard of care imaging [ Time Frame: 12 month ]
    Correlation between focal 18FDCFPyL uptake and focal abnormalities identified on standard of care imaging
  • Evaluate the distribution of 18FDCFPyL uptake in prostate cancer patients with biochemical relapse (site of recurrence unknown) as a function of PSA value [ Time Frame: 12 month ]
    PSA value of the distribution of 18FDCFPyL uptake in prostate cancer patients with biochemical relapse
  • Compare the distribution of 18FDCFPyL uptake with multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy [ Time Frame: 12 months ]
    Correlation between the distribution of 18F-DCFPyL uptake and multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Official Title  ICMJE (18)F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Brief Summary

Background:

Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.

Objectives:

To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy.

Eligibility:

Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery

Design:

Participants will be screened with medical history and physical exam. They will have blood taken.

Participants will be divided into 2 groups.

  • Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy.
  • Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy.

Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.

Participants will be contacted for follow-up after scans.

Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV.

Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan.

Participants will have data about their prostate cancer collected for up to 1 year.

Detailed Description

Background

  • Prostate cancer (PCa) is the second leading cause of cancer death in American men.
  • Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy
  • Recurrence of PCa after surgery or radiation is very common and sometimes progresses to death.
  • Early intervention for recurrence has been shown to be of benefit but current methods of localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone scan) Many prostate cancers express the prostate specific membrane antigen (PSMA) a transmembrane protein with NAALADase (N-acetylated-alphalinked- acidic dipeptidase) and folate hydrolase enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited expression in normal tissue.
  • An initial test of (18)F-DCFBC, a first-generation PET agent targeting PSMA, in patients with advanced local disease and biochemically recurrent prostate cancer demonstrated the potential of PET to detect sites of recurrence but it was hampered by excessive blood pool activity.
  • (18)F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may provide a new tool in staging high risk cancers and detecting recurrent disease.

Primary Objective

- To assess the ability of (18)F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer.

Eligibility

  • Age greater than or equal to 18 years old
  • ECOG 0-2
  • Histologically confirmed adenocarcinoma of the prostate
  • Patients fit criteria for one of the following categories:

    • Cohort 1: known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage greater than or equal to T2c) with evidence of disease on standard imaging, or
    • Cohort 2: nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/ml

Design

  • This is a single site study enrolling a total of 330 patients

    • Up to 50 evaluable patients with presumed localized high-risk prostate cancerscheduled to undergo prostatectomy or biopsy within 4 months of enrollment.
    • 250 evaluable patients with suspected recurrent prostate cancer without definitive evidence of disease on conventional imaging will be enrolled.
  • Up to 5 eligible patients in cohort 2 will receive a second 18F-DCFPyL PET/CT scan within 1 month of the first study immediately after unilateral salivary gland cannulation and an infusion of unlabeled DCFPyL into the cannulated gland.
  • To account for the non-evaluable patients the accrual ceiling will be set to 330.
  • All patients will undergo a standard of care, clinical multiparametric endorectal coil MRI in the NCI Molecular Imaging Clinic within 4 months of the PET scan.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prostate Neoplasms
  • Prostatic Cancer
  • Prostate Cancer
  • Cancer Of Prostate
  • Metastatic Prostate Cancer
Intervention  ICMJE Drug: 18F-DCFPyL
Subjects will receive IV dose of 18F-DCFPyL by bolus injection. The maximum amount of injected active drug will be less than 4.02 mcg. The target administered activity will be 8 mCi.
Study Arms  ICMJE
  • Experimental: 1-Localized High risk
    18F-DCFPyL PET/CT imaging and possible prostatectomy
    Intervention: Drug: 18F-DCFPyL
  • Experimental: 2-Biochemical recurrence (BCR)
    18F-DCFPyL PET/CT imaging
    Intervention: Drug: 18F-DCFPyL
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 8, 2017)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2022
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:
  • Age greater than or equal to 18 years old
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Histologically confirmed adenocarcinoma of the prostate
  • Patients fit criteria for one of the following categories:
  • Cohort 1

    --known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage >T2c) with evidence of disease on standard imaging, OR

  • Cohort 2

    • nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL
    • Patients must be willing to undergo mandatory research biopsy

EXCLUSION CRITERIA:

  • Subjects for whom participating would significantly delay the scheduled standard of care therapy.
  • Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
  • Subjects with severe claustrophobia unresponsive to oral anxiolytics
  • Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
  • Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
  • Subjects receiving androgen deprivation therapy (ADT)
  • Serum creatinine greater than 2 times the upper limit of normal
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: Yolanda McKinney, R.N. (240) 760-6095 ymckinney@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181867
Other Study ID Numbers  ICMJE 170109
17-C-0109
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter L Choyke, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 23, 2019

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