Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine in Prostate Cancer Patients - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00139204

Purpose

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.

Condition	Intervention
Prostate Cancer	Procedure: C11 Methionine PET scan

MedlinePlus related topics: Cancer Nuclear Scans Prostate Cancer

Drug Information available for: Methionine Carbon-11 methionine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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)

Further study details as provided by Dana-Farber Cancer Institute:

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

Estimated Enrollment:	20
Study Start Date:	April 2005
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139204

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Investigators

Principal Investigator:

Robert Ross, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Study ID Numbers:	04-419
Study First Received:	August 29, 2005
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00139204 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Prostate cancer
Hormone-refractory prostate cancer
PET scan
C11-methionine
positron emission tomography

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Urinary Retention
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009