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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00804245 |
RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.
PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.
Condition | Intervention |
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Prostate Cancer |
Drug: C-11 choline Procedure: bone scan Procedure: computed tomography Procedure: needle biopsy |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | A Pilot Study of Use of 11C-Choline PET-CT in the Metastatic Evaluation of Patients With Newly Diagnosed High Risk Adenocarcinoma of the Prostate |
Estimated Enrollment: | 78 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo CT scan of the abdomen and pelvis with IV contrast and a bone scan. Patients also undergo a C-11 choline PET-CT scan*. In the case of any positive scan, patients undergo a needle biopsy. If the biopsy is negative for metastatic disease or if the biopsy is positive for metastatic disease in a draining lymph node region, patients receive radiotherapy and hormonal (antiandrogen) therapy. If the biopsy is positive for metastatic disease at any other site, patients receive hormonal therapy alone.
NOTE: *The first 10 patients enrolled on the study who have a positive PET-CT scan and positive biopsy undergo a second PET-CT scan at 6 months after the initial PET-CT scan.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
High-risk disease, as defined by one of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | Recruiting |
Winston-Salem, North Carolina, United States, 27157-1096 | |
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 |
Study Chair: | Pradeep Garg, PhD | Wake Forest University |
Investigator: | Daniel Fried, MD | Wake Forest University |
Responsible Party: | Wake Forest University Comprehensive Cancer Center ( Pradeep Garg ) |
Study ID Numbers: | CDR0000627716, CCCWFU-85207 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804245 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Signs and Symptoms Choline Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Antimetabolites Nootropic Agents Lipotropic Agents Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Antilipemic Agents Gastrointestinal Agents Central Nervous System Agents Pharmacologic Actions |