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

NCT00392938 | Completed

• 6 other identifiers: 6129P30CA015704UWCC-6129UWCC-06-0500-H/AFHCRC-6129CDR0000480347
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Cancer; Prostate Cancer

Keywords

recurrent prostate cancer; stage IV prostate cancer; bone metastases

Outcome Measures

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 (5)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms

Interventions

Androgen Antagonists; Docetaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Evan Y. Yu, MD

  Seattle Cancer Care Alliance

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: December 1, 2005
• Primary Completion: May 1, 2010
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (2)