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

NCT ID: NCT00392938

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-12-31

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.

Conditions

Metastatic Cancer; Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

antiandrogen therapy

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

C-11 acetate PET scan

Intervention Type: DIAGNOSTIC_TEST

F-18 FDG PET scan

Intervention Type: DIAGNOSTIC_TEST

Tc-99m bone scan

Intervention Type: DIAGNOSTIC_TEST

CT scan of the chest, abdomen and pelvis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Evan Y. Yu, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evan Y. Yu, MD

Role: STUDY_CHAIR

Seattle Cancer Care Alliance

Locations

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University of Washington School of Medicine

Seattle, Washington, United States

Countries

United States

Other Identifiers

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UWCC-6129

Identifier Type: -

Identifier Source: secondary_id

UWCC-06-0500-H/A

Identifier Type: -

Identifier Source: secondary_id

FHCRC-6129

Identifier Type: -

Identifier Source: secondary_id

CDR0000480347

Identifier Type: REGISTRY

Identifier Source: secondary_id

6129

Identifier Type: -

Identifier Source: org_study_id