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CompletedNCT00392938Updated Mar 13, 2017

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

An observational study in Metastatic Cancer and Prostate Cancer, sponsored by University of Washington. Completed at 2 sites in United States. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-03-13.

Sponsored by University of Washington · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
11
Ages
18 Years to 120 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Metastatic Cancer
  • Prostate Cancer

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Keywords

  • recurrent prostate cancer
  • stage IV prostate cancer
  • bone metastases
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 11 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Interventions

  • Drugantiandrogen therapy
  • Drugdocetaxel
  • Diagnostic testC-11 acetate PET scan
  • Diagnostic testF-18 FDG PET scan
  • Diagnostic testTc-99m bone scan
  • Diagnostic testCT scan of the chest, abdomen and pelvis
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

2 sites
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
  • University of Washington School of Medicine
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00392938
Lead sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
Responsible party
Evan Y. Yu, MD (Principal Investigator, University of Washington) — Principal investigator
First posted
Oct 26, 2006
Start date
Dec 2005
Primary completion
May 2010
Last update
Mar 13, 2017

Study contacts

Evan Y. Yu, MD
study chair · Seattle Cancer Care Alliance
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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