Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine in Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C11 Methionine PET scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Hormone-refractory prostate cancer, PET scan, C11-methionine, positron emission tomography
Eligibility Criteria
Inclusion Criteria: Metastatic hormone-refractory prostate cancer patients who are planned to begin every 3-week docetaxel chemotherapy Progression after androgen deprivation therapy Serum testosterone < 50ng/ml 18 years of age or older Exclusion Criteria: Prior taxane therapy
Sites / Locations
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
Outcomes
Primary Outcome Measures
To describe the association between percent change in tumor standardized uptake value (SUV) after c11 methionine administration after one cycle of every three-week docetaxel-based chemotherapy and prostate-specific antigen (PSA) response
Secondary Outcome Measures
To explore the relative value of the change in tumor SUV after C11 methionine administration after one cycle and 3 cycles of docetaxel with respect to PSA progression
to explore optimal cutpoints and measures of SUV change for distinguishing responders from non-responders and progressors from non-progressors and
to evaluate the relationship between the percent change is tumor SUV after C11 methionine administration with freedom from PSA progression in 6 months
Full Information
NCT ID
NCT00139204
First Posted
August 29, 2005
Last Updated
October 30, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00139204
Brief Title
Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine in Prostate Cancer Patients
Official Title
An Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine (C11 MET) in Prostate Cancer, as Assessed by Positron Emission Tomography (PET)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to better understand a new type of radiology test called positron emission tomography (PET) with carbon 11 methionine to determine which patients have a beneficial effect from anti-cancer therapy with the drug docetaxel.
Detailed Description
In the week before the patients first dose of chemotherapy they will receive a C11 methionine PET scan which takes about 90 minutes. C11 methionine is a radioactively labeled amino acid that is given to the patient intravenously.
Eighteen to twenty days after the patients first dose of docetaxel chemotherapy, they will have another C11 methionine PET scan which is identical to the first scan.
At the end of three cycles of docetaxel chemotherapy (about 2 and 1/2 months on study) another C11 methionine PET scan will be done.
The PET scans will show how well the tumor is taking up methionine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Hormone-refractory prostate cancer, PET scan, C11-methionine, positron emission tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
C11 Methionine PET scan
Primary Outcome Measure Information:
Title
To describe the association between percent change in tumor standardized uptake value (SUV) after c11 methionine administration after one cycle of every three-week docetaxel-based chemotherapy and prostate-specific antigen (PSA) response
Secondary Outcome Measure Information:
Title
To explore the relative value of the change in tumor SUV after C11 methionine administration after one cycle and 3 cycles of docetaxel with respect to PSA progression
Title
to explore optimal cutpoints and measures of SUV change for distinguishing responders from non-responders and progressors from non-progressors and
Title
to evaluate the relationship between the percent change is tumor SUV after C11 methionine administration with freedom from PSA progression in 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic hormone-refractory prostate cancer patients who are planned to begin every 3-week docetaxel chemotherapy
Progression after androgen deprivation therapy
Serum testosterone < 50ng/ml
18 years of age or older
Exclusion Criteria:
Prior taxane therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ross, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine in Prostate Cancer Patients
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