Clinical trial 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
Official title: Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Prostate Cancer
Keywords: recurrent prostate cancer
stage IV prostate cancer
bone metastases
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-10-26
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE

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.

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.

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

Primary outcomes:
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 outcomes:
measure: Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response
measure: Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level
measure: Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales)
measure: Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression
measure: PET scan response as a predictor of duration of progression-free survival
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: Seattle Cancer Care Alliance
name: Evan Y. Yu, MD
role: STUDY_CHAIR
References: