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

March 8, 2017 updated by: Evan Y. Yu, MD, University of Washington

Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington School of Medicine
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Evan Y. Yu, MD, Seattle Cancer Care Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6129
  • P30CA015704 (U.S. NIH Grant/Contract)
  • UWCC-6129
  • UWCC-06-0500-H/A
  • FHCRC-6129
  • CDR0000480347 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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