Back to resultsEvaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
Primary Purpose
Metastatic Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-DCFBC
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Prostate Cancer focused on measuring Metastatic Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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, and/or [18F]FDG PET
- Rising PSA on two observations taken at least 1 week apart
- Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
- Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
- Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
- 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
Exclusion Criteria:
- Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
- 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)
- Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
- 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
- Unable to lie flat during or tolerate PET/CT
- 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.
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-DCFBC
Arm Description
Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
Outcomes
Primary Outcome Measures
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)
Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.
Secondary Outcome Measures
Sensitivity of Detection of New or Progression of Metastasis
Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where "equivocal" lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed.
Full Information
NCT ID
NCT01815515
First Posted
March 18, 2013
Last Updated
August 17, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1. Study Identification
Unique Protocol Identification Number
NCT01815515
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
November 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
Metastatic Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-DCFBC
Arm Type
Experimental
Arm Description
Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
Intervention Type
Drug
Intervention Name(s)
18F-DCFBC
Other Intervention Name(s)
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-18F-fluorobenzyl-L-cysteine
Intervention Description
18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA).
A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
Primary Outcome Measure Information:
Title
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)
Description
Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Sensitivity of Detection of New or Progression of Metastasis
Description
Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where "equivocal" lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed.
Time Frame
up to 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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, and/or [18F]FDG PET
Rising PSA on two observations taken at least 1 week apart
Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
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
Exclusion Criteria:
Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
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)
Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
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
Unable to lie flat during or tolerate PET/CT
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zsolt Szabo, M.D
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
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