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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Metastatic Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: antiandrogen therapy; Diagnostic test: 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

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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington School of Medicine
    • Seattle, Washington, United States, 98109-1024
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Evan Y. Yu, MD, Seattle Cancer Care Alliance

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: October 25, 2006
• First Submitted That Met QC Criteria: October 25, 2006
• First Posted (Estimate): October 26, 2006

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: stage IV prostate cancer; recurrent prostate cancer; bone metastases
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Docetaxel; Androgen Antagonists
• Other Study ID Numbers: 6129; P30CA015704 (U.S. NIH Grant/Contract); UWCC-6129; UWCC-06-0500-H/A; FHCRC-6129; CDR0000480347 (Registry Identifier: PDQ)