C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
needle biopsy
PET-CT scans supplemented with 11C-Choline tracer
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Prior negative prostate biopsy allowed
- High-risk disease, as defined by one of the following:
- PSA ≥ 20 ng/mL
- Gleason score ≥ 8
- Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)
- Creatinine < 2.0 mg/dL
- Able to tolerate PET scan, CT scan, and bone scan
- Able to tolerate IV and oral contrast
- Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan
Exclusion Criteria:
- Other cancer within the past 5 years (except for nonmelanoma skin cancer)
- No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed
Sites / Locations
- Wake Forest University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
radiolabeled choline tracer scans
Arm Description
PET-CT scans supplemented with Choline 11 tracer
Outcomes
Primary Outcome Measures
Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.
Secondary Outcome Measures
Full Information
NCT ID
NCT00804245
First Posted
December 5, 2008
Last Updated
July 2, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00804245
Brief Title
C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
Official Title
A Pilot Study of Use of 11C-Choline PET-CT in the Metastatic Evaluation of Patients With Newly Diagnosed High Risk Adenocarcinoma of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.
PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.
Detailed Description
OBJECTIVES:
Primary
To determine the sensitivity and specificity of PET-CT scan using C-11 choline in detecting bone and lymph node metastases in patients with newly diagnosed high-risk adenocarcinoma of the prostate.
Secondary
To perform semi-quantitative analysis of tracer uptake using standard uptake values and qualitative analysis using pure visual analysis.
To develop an algorithm that includes the routine use of C-11 choline PET-CT scan for the staging of patients with prostate cancer at high risk of metastatic disease.
To determine whether the presence of C-11 choline PET-CT scan positivity in these patients is predictive of outcomes, including biochemical relapse-free survival, time to development of clinically apparent metastases, time to local failure, and overall survival.
To obtain tissue specimens from these patients for correlative studies and further evaluation.
To obtain information regarding the feasibility and characteristics of C-11 choline PET-CT scan after androgen suppression.
OUTLINE: Patients undergo CT scan of the abdomen and pelvis with IV contrast and a bone scan. Patients also undergo a C-11 choline PET-CT scan*. In the case of any positive scan, patients undergo a needle biopsy. If the biopsy is negative for metastatic disease or if the biopsy is positive for metastatic disease in a draining lymph node region, patients receive radiotherapy and hormonal (antiandrogen) therapy. If the biopsy is positive for metastatic disease at any other site, patients receive hormonal therapy alone.
NOTE: *The first 10 patients enrolled on the study who have a positive PET-CT scan and positive biopsy undergo a second PET-CT scan at 6 months after the initial PET-CT scan.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
radiolabeled choline tracer scans
Arm Type
Experimental
Arm Description
PET-CT scans supplemented with Choline 11 tracer
Intervention Type
Procedure
Intervention Name(s)
needle biopsy
Intervention Description
Biopsy of positive findings found on CT scan
Intervention Type
Drug
Intervention Name(s)
PET-CT scans supplemented with 11C-Choline tracer
Intervention Description
Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer
Primary Outcome Measure Information:
Title
Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
Description
To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.
Time Frame
Approximately 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
Prior negative prostate biopsy allowed
High-risk disease, as defined by one of the following:
PSA ≥ 20 ng/mL
Gleason score ≥ 8
Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)
Creatinine < 2.0 mg/dL
Able to tolerate PET scan, CT scan, and bone scan
Able to tolerate IV and oral contrast
Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan
Exclusion Criteria:
Other cancer within the past 5 years (except for nonmelanoma skin cancer)
No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradeep Garg, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
12. IPD Sharing Statement
Learn more about this trial
C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
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