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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00139204
First received: August 29, 2005
Last updated: October 30, 2009
Last verified: October 2009
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00139204     History of Changes
Other Study ID Numbers: 04-419
Study First Received: August 29, 2005
Last Updated: October 30, 2009
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014