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

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ClinicalTrials.gov Identifier: NCT03181867
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease Intervention/treatment Phase
Prostate Neoplasms Prostatic Cancer Prostate Cancer Cancer Of Prostate Metastatic Prostate Cancer Drug: 18F-DCFPyL Phase 2

National Cancer Institute (NCI) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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 > 0.2 ng/ml

Design

This is a single site study enrolling a total of 330 patients; 55 patients with presumed localized high risk prostate cancer scheduled to undergo prostatectomy or biopsy within 4 months of enrollment and 275 patients with suspected recurrent prostate cancer without definitive evidence of disease on conventional imaging. 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: (18)F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1-Localized High risk
18F-DCFPyL PET/CT imaging and possible prostatectomy
Drug: 18F-DCFPyL
Subjects will receive 18F-DCFPyL under the direct supervision of study personnel. Each subject will receive a single IV dose of 18F-DCFPyL by bolus injection at a rate of approximately 1ml/3-5sec. The maximum amount of injected active drug will be less than 4.02mcg. The injection will be followed by a 10 ml saline flush (sodium chloride IV infusion 0.9% w/v) over approx 10sec. The target administered activity will be 8 mCi.
Experimental: 2-Biochemical recurrence (BCR)
18F-DCFPyL PET/CT imaging
Drug: 18F-DCFPyL
Subjects will receive 18F-DCFPyL under the direct supervision of study personnel. Each subject will receive a single IV dose of 18F-DCFPyL by bolus injection at a rate of approximately 1ml/3-5sec. The maximum amount of injected active drug will be less than 4.02mcg. The injection will be followed by a 10 ml saline flush (sodium chloride IV infusion 0.9% w/v) over approx 10sec. The target administered activity will be 8 mCi.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • 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
  • Total bilirubin greater than 2 times the upper limit of normal
  • Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181867


Contacts
Contact: Yolanda McKinney, R.N. (301) 443-6913 ymckinney@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter L Choyke, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03181867     History of Changes
Other Study ID Numbers: 170109
17-C-0109
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 7, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
PET/ CT
Endorectal MRI
Imaging
PSMA
Prostate Cancer Relapse

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases