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CompletedNCT03497377Updated May 7, 2020

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

A Phase 1 interventional study of 18F-DCFPyL Injection and 18F-NaF in Metastatic Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
Male
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Study summary

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. 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. Investigators 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.

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Conditions studied

  • Metastatic Prostate Cancer

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Histological confirmation of prostate cancer
  2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET
  3. Rising PSA on two observations taken at least 1 week apart
  4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
  5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
  6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
  7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
  8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures

Exclusion criteria

Exclusion Criteria:

  1. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
  2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
  3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
  4. Serum creatinine > 3 times the upper limit of normal
  5. Total bilirubin > 3 times the upper limit of normal
  6. Liver Transaminases > 5times the upper limit of normal
  7. Unable to lie flat during or tolerate PET/CT (or PET/MRI imaging if available)
  8. Prior history of any other malignancy within last 2 years, other than skin basal cell carcinoma or superficial bladder cancer.
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Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    18F-DCFPyL Injection & 18F-NaF

    A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL injected by slow IV push. A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose

    Drug: 18F-DCFPyL Injection · Drug: 18F-NaF

Interventions

  • Drug18F-DCFPyL Injection
  • Drug18F-NaF
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What researchers measure

Primary outcomes

  1. Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT

    Compare the diagnostic accuracy during visit 2 18F-DCFPyL imaging and visit 3 NaF imaging

    Time frame: 4 years

Secondary outcomes

  1. Estimation of new or progressive metastatic lesions found on NaF and 18F-DCFPyL

    Compare proportion of new or progressive metastatic lesions found on NaF-PET/CT that are DCFPyL- PET/CT (or PET/MRI imaging if available) positive, and vice-versa.

    Time frame: 4 years

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Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
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Registry details

Key details

Study ID
NCT03497377
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 13, 2018
Start date
May 16, 2016
Primary completion
Apr 2020
Completion
Apr 2020
Last update
May 7, 2020

Study contacts

Martin Pomper, MD,PhD
principal investigator · Department of Nuclear Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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