Status:

COMPLETED

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

Lead Sponsor:

University of Washington

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Metastatic Cancer

Prostate Cancer

Eligibility:

MALE

18-120 years

Brief Summary

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 acetat...

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 clinic...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 1 2005

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    11 Patients enrolled

    Trial Details

    Trial ID

    NCT00392938

    Start Date

    December 1 2005

    Last Update

    March 13 2017

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States, 98109-1024

    2

    University of Washington School of Medicine

    Seattle, Washington, United States, 98195