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Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer

Phase 1 Biodistribution and Pharmacokinetic Study of 18F-DCFBC PSMA Based PET in Patients With Advanced Prostate Cancer

NCT01417182•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

Prostate cancer is the most common cancer among men in the United States. Through early detection and improved local therapies a large number of men will be cured. The clinical needs include early detection, accurate initial staging and detection of local recurrence or metastases in order to permit application of the most appropriate therapy. Therapeutic monitoring and prognostic assessment are equally important. Imaging can play an important and crucial role in meeting these clinical needs. Positron emission tomography (PET) imaging has gained an important role in the clinical management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18 positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging prostate cancer. This initial phase I study will determine the biodistribution, pharmacokinetics, and prostate specific tumor uptake in patients with metastatic prostate cancer.

Detailed Description

Eligibility

Age

18 - 90 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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).
+1 more criteria

Locations (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

January 17, 2019

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

18F-DCFBC

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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