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

Phase 1
18 Years
90 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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.

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

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

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Serial PET scans will be used to obtain biodistribution and radiation dosimetry calculations.

Outcome Description:

Time-activity curves (TACs) demonstrating radiotracer activity as a function of time post injection (minutes) will be drawn for the whole body and the following organs: brain, breast, gallbladder, stomach, pancreas, heart wall, lung, liver, bladder, muscle, pancreas, red marrow, spleen, adrenals, upper large intestine, lower large intestine, small intestine, thymus, thyroid, testes and ovaries.Organ specific mean radiation-absorbed dose estimates for 18F-DCFBC will be calculated from the individual organ residence times. The OLINDA software package will be used to perform the absorbed dose.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Steve Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Patients with Advanced Prostate Cancer
  • Prostatic Neoplasms



Johns Hopkins Outpatient CenterBaltimore, Maryland  21287