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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

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

Eligibility Criteria

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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