Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone - Full Text View

Sponsored by:	Fred Hutchinson Cancer Research Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00392938

Purpose

RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone.

Condition	Intervention
Metastatic Cancer Prostate Cancer	Drug: carbon-11 acetate Drug: docetaxel Drug: fludeoxyglucose F 18 Procedure: antiandrogen therapy Procedure: positron emission tomography Procedure: radionuclide imaging

MedlinePlus related topics: Cancer Nuclear Scans Prostate Cancer

Drug Information available for: Docetaxel Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation of pre-treatment and 3-month post-treatment carbon-11 (11C) acetate and fludeoxyglucose F 18 positron emission tomography (18F-FDG PET) images with changes in clinical response measures [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response [ Designated as safety issue: No ]
Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level [ Designated as safety issue: No ]
Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales) [ Designated as safety issue: No ]
Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression [ Designated as safety issue: No ]
PET scan response as a predictor of duration of progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2005
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Correlate pre-treatment and 3-month post-treatment carbon-11 (^11C) acetate and fludeoxyglucose F 18 positron emission tomography (^18F-FDG PET) images with changes in clinical response measures in patients with bone-dominant metastatic prostate cancer.

Secondary

Compare ^11C acetate and ^18F-FDG PET scanning results with bone scintigraphy in these patients to determine which best predicts clinical response.
Correlate changes in ^11C acetate and ^18F-FDG PET with changes in prostate-specific antigen level.
Correlate changes in ^11C acetate and ^18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales).
Correlate ^11C acetate and ^18F-FDG PET scan response with clinical time to progression.
Determine if PET scan response can predict duration of progression-free survival.

OUTLINE: This is a pilot study. Patients are stratified according to hormone response (sensitive [stratum 1] vs refractory [stratum 2]).

Patients undergo carbon-11 acetate and fludeoxyglucose F 18 positron emission tomography imaging prior to and 3 months after initiation of either androgen-deprivation therapy (stratum 1) or docetaxel (stratum 2).

Pain and quality of life are assessed at baseline and at 3 months.

Patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of prostate cancer, meeting 1 of the following criteria:
- Metastatic hormone-sensitive disease prior to initiation of first-line androgen-deprivation therapy and meets the following criteria:
  - Histologic confirmation of original diagnosis
  - Hormone-sensitive is defined as progressive disease in the absence of androgen-deprivation therapy
  - Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray
- Metastatic hormone-refractory disease prior to initiation of a first-line chemotherapy regimen that includes docetaxel and meets the following criteria:
  - Histologic confirmation of original diagnosis
  - Hormone-refractory is defined as development or advancement of metastatic disease with castrate testosterone levels (total testosterone < 20 ng/dL)
  - Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray
  - Must have castrate testosterone levels (< 20 ng/dL) from orchiectomy or undergoing maintenance with a luteinizing hormone-releasing hormone agonist
    - Outside the window of a potential antiandrogen withdrawal response (either decline in prostate-specific antigen or objective response by imaging)

PATIENT CHARACTERISTICS:

Life expectancy > 12 weeks
No serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and undergo imaging studies
No condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
Able to lie still for the imaging
Weight ≤ 300 lbs

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 6 weeks since prior bicalutamide or nilutamide
At least 4 weeks since prior flutamide, ketoconazole, diethylstilbestrol, or estradiol
More than 4 weeks since prior bisphosphonate therapy
More than 4 weeks since prior radiotherapy to the bone
More than 4 weeks since prior radiopharmaceutical treatment to the bone
No concurrent radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392938

Locations

United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Evan Y. Yu, MD 206-288-6525 evanyu@u.washington.edu
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824
University of Washington School of Medicine	Recruiting
Seattle, Washington, United States, 98195
Contact: Clinical Trials Office - University of Washington School of Me 206-616-8289

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

Investigators

Study Chair:

Evan Y. Yu, MD

Fred Hutchinson Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000480347, UWCC-UW-6129, UWCC-06-0500-H/A, FHCRC-6129
Study First Received:	October 25, 2006
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00392938
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer
stage IV prostate cancer
bone metastases

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009