search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-DCFBC
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring Patients with Advanced Prostate Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Outpatient Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melanoma

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess the ability of 18F-DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis
Correlation will be made to sites of suspected metastatic disease seen on CT portion of PET/CT, available conventional imaging modalities (CIM) (anatomical imaging [CT, MRI, ultrasound], bone scintigraphy or FDG PET) or serum PSA performed for clinical indications

Full Information

First Posted
November 8, 2010
Last Updated
January 15, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Prostate Cancer Foundation, Radiological Society of North America
search

1. Study Identification

Unique Protocol Identification Number
NCT01417182
Brief Title
Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer
Official Title
Phase 1 Biodistribution and Pharmacokinetic Study of 18F-DCFBC PSMA Based PET in Patients With Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Prostate Cancer Foundation, Radiological Society of North America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Patients with Advanced Prostate Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melanoma
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
18F-DCFBC
Intervention Description
A bolus of 10 mCi (370 MBq) of 18F-DCFBC will be injected once into the IV line by slow push IV push.
Primary Outcome Measure Information:
Title
Serial PET scans will be used to obtain biodistribution and radiation dosimetry calculations.
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Assess the ability of 18F-DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis
Description
Correlation will be made to sites of suspected metastatic disease seen on CT portion of PET/CT, available conventional imaging modalities (CIM) (anatomical imaging [CT, MRI, ultrasound], bone scintigraphy or FDG PET) or serum PSA performed for clinical indications
Time Frame
one year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Cho, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs