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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00392938
Enrollment
11
Registered
2006-10-26
Start date
2005-12-31
Completion date
Unknown
Last updated
2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer, Prostate Cancer

Keywords

recurrent prostate cancer, stage IV prostate cancer, bone metastases

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.

Interventions

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026