Back to resultsPET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium Acetate C11
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Recurrent Prostate Carcinoma, sodium acetate c11, PET, prostate cancer, rising PSA, PSA recurrence, biochemical recurrence
Eligibility Criteria
Inclusion Criteria:
- recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)
Exclusion Criteria:
- < 18 years old
- claustrophobic patients
Sites / Locations
- Phoenix Molecular Imaging
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sodium Acetate C11 PET Imaging
Arm Description
Outcomes
Primary Outcome Measures
SUV (Standardized Uptake Value)
Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
Secondary Outcome Measures
PSA (prostate specific antigen)
PSA will be monitored per routine clinical follow-up.
Full Information
NCT ID
NCT01304485
First Posted
February 24, 2011
Last Updated
March 5, 2019
Sponsor
Phoenix Molecular Imaging
1. Study Identification
Unique Protocol Identification Number
NCT01304485
Brief Title
PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Official Title
Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix Molecular Imaging
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy
Detailed Description
The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.
A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.
The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.
Specific questions to be addressed:
What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?
How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT?
What is the optimal imaging protocol in terms of imaging time after injection?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Recurrent Prostate Carcinoma, sodium acetate c11, PET, prostate cancer, rising PSA, PSA recurrence, biochemical recurrence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Acetate C11 PET Imaging
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sodium Acetate C11
Other Intervention Name(s)
Carbon 11 Acetate PET, C11 Acetate, AC-PET
Intervention Description
PET Imaging with Sodium Acetate C11
Primary Outcome Measure Information:
Title
SUV (Standardized Uptake Value)
Description
Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
Time Frame
Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration
Secondary Outcome Measure Information:
Title
PSA (prostate specific antigen)
Description
PSA will be monitored per routine clinical follow-up.
Time Frame
Every 3 - 6 months for 24 months after PET imaging
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)
Exclusion Criteria:
< 18 years old
claustrophobic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Almeida, M.D.
Organizational Affiliation
Medical Director, Phoenix Molecular Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Molecular Imaging
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85040
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Journal Publication
Learn more about this trial
PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
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