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 Hormone-Refractory Prostate Cancer	Procedure: C11 Methionine PET scan

Further Study Details: 

Primary Outcomes: To describe the association between percent change in tumor SUV after c11 methionine administration after one cycle of every three-week docetaxel-based chemotherapy and PSA response.
Secondary Outcomes: 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.
Expected Total Enrollment:  20

• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00139204

Robert Ross, MD       robert_ross@dfci.harvard.edu

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

Study chairs or principal investigators

Robert Ross, MD,  Principal Investigator,  Dana-Farber Cancer Institute   

Study ID Numbers:  04-419
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139204
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06