Metastatic Cancer, Prostate Cancer
Conditions
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
Sponsors
Study design
Eligibility
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
| Measure | Time 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
| Measure | Time 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