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

Phase 1

Completed

• Conditions: Metastatic Prostate Cancer
• Interventions: Drug: 18F-DCFPyL

• Registration Number: NCT02151760
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DCFPyL	18F-DCFPyL	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States