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

Completed · Phase 1

Conditions studied: Metastatic Prostate Cancer

In brief

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

Key facts

Study ID

NCT02151760

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

37

Starts

2014-05-01

Expected to finish

2020-04-01

Last updated by the study team

2020-05-07

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:
• Greater than or equal to 18 years of age
• Histological confirmation of prostate cancer
• 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
• PSA ≥ 1.0 ng/mL
• Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
• Platelet count > 50,000/mm3
• Neutrophil count > 1,000/mm3
• 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.
• 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.

You may not qualify if…

• Patients will be excluded from enrollment if any of the following apply:
• Karnovsky performance status of < 60
• Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
• Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
• Administered a radioisotope within 5 physical half-lives prior to study enrollment
• Serum creatinine > 3 times the upper limit of normal
• Total bilirubin > 3 times the upper limit of normal
• Liver Transaminases > 5times the upper limit of normal
• Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
• 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).
• Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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