Clinical trial NCT01815515: Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
Official title: Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Prostate Cancer
Keywords: Metastatic Prostate Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.

Detailed description: The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.

Eligibility criteria: Inclusion Criteria:

1. Histological confirmation of prostate cancer
2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, \[18F\]Sodium Fluoride PET, and/or \[18F\]FDG PET
3. Rising PSA on two observations taken at least 1 week apart
4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
7. 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
8. 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:

1. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
4. Serum creatinine \> 3 times the upper limit of normal
5. Total bilirubin \> 3 times the upper limit of normal
6. Liver Transaminases \> 5times the upper limit of normal
7. Unable to lie flat during or tolerate PET/CT
8. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Primary outcomes:
measure: Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)
timeFrame: 24 Months
Secondary outcomes:
measure: Sensitivity of Detection of New or Progression of Metastasis
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Zsolt Szabo, M.D
role: PRINCIPAL_INVESTIGATOR
References: