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18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03173924
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : June 20, 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. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body.

Objective:

To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.

Eligibility:

People ages 18 and older who have metastatic prostate cancer

Design:

Participants will be screened with:

  • Blood tests
  • Physical exam
  • Medical history

Participants will be assigned to 1 of 2 groups based on their PSA.

Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission

Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes.

On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT.

Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis.

If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor.

Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results.

About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor.


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

Expanded Access : 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:

  • The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F] DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer
  • PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential
  • Our preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection.
  • We propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra-sensitive but less specific [18F] Sodium

Fluoride (NaF)-PET/CT imaging for prostate cancer.

OBJECTIVES:

- To compare the diagnostic sensitivity of DCFPyL-PET/CT (or PET/MRI imaging if available) to NaF-PET/CT for detection of prostate cancer bone metastasis based on comparison to reference standard of care conventional imaging modalities (CIM); such as CT

and whole body bone scintigraphy incorporating prior and follow-up scans and histopathology when available.

ELIGIBILITY:

  • Histological confirmation of prostate cancer
  • Radiologic evidence of metastatic bone disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [^18F] Sodium Fluoride (NaF)-PET, and/or [^18F] FDG PET
  • Age greater than or equal to 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
  • Confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater.

DESIGN:

  • Two Cohort study

    • Cohort 1: Stable Prostate Specific Antigen (PSA): PSA must be within 0.5 value of the last PSA obtained (at least one month apart).
    • Cohort 2: Rising PSA: PSA must be greater than 0.5 above the last PSA value obtained on at least two occasions within 1 year
  • Patients will undergo DCFPyL PET/CT (or PET/MRI) and NaF-PET/CT within 21 days of each other. The order obtained does not matter.
  • The DCFPyL PET/CT (or PET/MRI) will be compared with the NaF-PET/CT and standard chest/abdomen/pelvis CT
  • DCFPyL PET/CT (or PET/MRI) detection of metastatic disease will be assessed by visual qualitative assessment as positive, equivocal, or negative. Sites of equivocal or positive metastatic disease will have a quantitative PET assessment (SUVmax, SUVmean).
  • A mandatory research biopsy will be performed under image guidance on a suspicious lesion, if feasible.
  • The patients will be followed by chart review, phone-call, and/or email follow-up for PSA relapse and radiologic evidence of metastatic disease over a one-year period from the time of imaging.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
18F-NaF and 18FDCFPyL
Drug: 18F-NaF
IV x 1 followed by PET/CT IMAGING

Drug: 18F-DCFPyL
IV x 1 (or x2) followed by PET/CT IMAGING




Primary Outcome Measures :
  1. Accuracy of DCFPyL-PET/CT diagnostics [ Time Frame: 36 months ]
    Accuracy of DCFPyL-PET/CT diagnostics


Secondary Outcome Measures :
  1. PSMA expression in lesion samples from patients with presumed stable disease and actively expanding disease [ Time Frame: 36 months ]
    Correlation between PSMA expression and PSA levels

  2. Association between PSA parameters and the number of metastases identified with DCFPyL- PET/CT (or PET/MRI imaging if available). [ Time Frame: 36 months ]
    Correlation between PSA parameters and the number of metastases identified with DCFPyLPET/CT



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Subject is 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.
  • Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater.
  • Histological confirmation of prostate cancer
  • 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
  • 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): NCT03173924


Contacts
Contact: Yolanda McKinney, R.N. (240) 760-6095 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: NCT03173924     History of Changes
Other Study ID Numbers: 170089
17-C-0089
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: March 20, 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) ):
Small Molecule
Radiolabeled
PSA
Diagnostic
PMSA

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