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Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Completed
CT.gov ID
NCT02151760
Collaborator
National Cancer Institute (NCI) (NIH)
37
Enrollment
1
Location
1
Arm
71
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

To assess the hypothesis that this new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging metastatic prostate cancer in ten patients diagnosed with metastatic prostate cancer.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer
Actual Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-DCFPyL

Drug: 18F-DCFPyL
Other Names:
  • 10.0 A bolus of less than or equal to 9 mCi (331 MBq) of 18F-DCFPyL will be injected into the IV line by slow push IV push.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PET/CT Detection of Metastatic Disease [12 months]

      To comare diagnostic accuracy of 18-DCFPyL to CIM(CT and bone scintigraphy) for the detection of metastatic prostate cancer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:

    1. Greater than or equal to 18 years of age

    2. Histological confirmation of prostate cancer

    3. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET

    4. PSA ≥ 1.0 ng/mL

    5. Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.

    6. Platelet count > 50,000/mm3

    7. Neutrophil count > 1,000/mm3

    8. 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.

    9. 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:
    • Patients will be excluded from enrollment if any of the following apply:

    1. Karnovsky performance status of < 60

    2. Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)

    3. Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)

    4. Administered a radioisotope within 5 physical half-lives prior to study enrollment

    5. Serum creatinine > 3 times the upper limit of normal

    6. Total bilirubin > 3 times the upper limit of normal

    7. Liver Transaminases > 5times the upper limit of normal

    8. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration

    9. Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).

    10. Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins University Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Steve Y Cho, M.D., Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT02151760
    Other Study ID Numbers:
    • J1418
    • NA_00092956
    • P50CA103175
    First Posted:
    May 30, 2014
    Last Update Posted:
    May 7, 2020
    Last Verified:
    May 1, 2020
    Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Metastatic Prostate Cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of May 7, 2020