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Completed

NCT Number: NCT00392938

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

Male

Study type

Observational

Primary location

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antiandrogen Therapy

Drug

docetaxel

Drug

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

Diagnostic Test

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
First posted
Oct 26, 2006
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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