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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392938
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Evan Y. Yu, MD, University of Washington

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 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone.


Condition or disease Intervention/treatment
Metastatic Cancer Prostate Cancer Drug: antiandrogen therapy Drug: docetaxel Diagnostic Test: C-11 acetate PET scan Diagnostic Test: F-18 FDG PET scan Diagnostic Test: Tc-99m bone scan Diagnostic Test: CT scan of the chest, abdomen and pelvis

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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
Study Start Date : December 2005
Actual Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response
  2. Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level
  3. Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales)
  4. Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression
  5. PET scan response as a predictor of duration of progression-free survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392938


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Study Chair: Evan Y. Yu, MD Seattle Cancer Care Alliance
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Responsible Party: Evan Y. Yu, MD, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00392938    
Other Study ID Numbers: 6129
P30CA015704 ( U.S. NIH Grant/Contract )
UWCC-6129
UWCC-06-0500-H/A
FHCRC-6129
CDR0000480347 ( Registry Identifier: PDQ )
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Keywords provided by Evan Y. Yu, MD, University of Washington:
recurrent prostate cancer
stage IV prostate cancer
bone metastases
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Androgen Antagonists
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs