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


N/A
18 Years
N/A
Not Enrolling
Male
Metastatic Cancer, Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

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

Safety Issue:

No

Principal Investigator

Evan Y. Yu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance

Authority:

United States: Institutional Review Board

Study ID:

6129

NCT ID:

NCT00392938

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Prostate Cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • bone metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Washington School of MedicineSeattle, Washington  98195