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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392938
• Other study ID #: 6129
• Secondary ID: P30CA015704UWCC-
• Status: Completed
• Phase: N/A
• First received: October 25, 2006
• Last updated: March 8, 2017
• Start date: December 2005

Study information

• Verified date: March 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• antiandrogen therapy

• docetaxel

Diagnostic Test:
• C-11 acetate PET scan

• F-18 FDG PET scan

• Tc-99m bone scan

• CT scan of the chest, abdomen and pelvis

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response
Secondary	Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level
Secondary	Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales)
Secondary	Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression
Secondary	PET scan response as a predictor of duration of progression-free survival