Clinical trial NCT00139204: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Hormone-refractory prostate cancer
PET scan
C11-methionine
positron emission tomography
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
First posted: 2005-08-31
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: to explore optimal cutpoints and measures of SUV change for distinguishing responders from non-responders and progressors from non-progressors and
measure: to evaluate the relationship between the percent change is tumor SUV after C11 methionine administration with freedom from PSA progression in 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Robert Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: