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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00588185 |
This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread.
Condition | Intervention |
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Prostate Cancer |
Other: PET scan |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer |
Estimated Enrollment: | 55 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
PET Scan
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Other: PET scan
PET scan performed to assess accumulation and biodistribution of FDHT
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Our preliminary studies have shown that whole body FDG-PET imaging identifies areas of abnormal metabolism in a majority of tumor sites in patients with progressive disease and that changes in FDG accumulation parallel changes in PSA after treatment. This suggests that changes in FDG metabolism may provide an early assessment of treatment outcomes. In previous work we established a methodology to examine a radiotracer in patients with progressive disease and abnormal imaging studies, which we have applied to the clinical states of non-castrate and castrate metastatic disease. This design is characterized by:
1) Evaluation of uptake on a site-by-site basis in relation to conventional studies 2) Standardization of uptake values in tumor relative to a normal organ 3) Controlling for progression using standard measures of progression including a rising PSA, new or enlarging lesions on bone or transaxial imaging, and new symptoms of disease. In the present study we are evaluating fluorinated dihydrotestosterone (FDHT) in addition to FDG. FDHT is targeted to the AR and has been shown in preliminary studies to visualize prostate cancers in man. This study will apply our established methods to investigate FDHT imaging in patients with progressive prostate cancer. In the selected cases where tumor is available, we will study associations between FDHT accumulation and AR expression.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Morris, M.D., PH.D. | morrism@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Michael Morris, M.D., Ph,D. morrism@mskcc.org | |
Principal Investigator: Michael Morris, M.D., Ph.D. |
Principal Investigator: | Michael Morris, M.D., Ph.D. | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Michael Morris, M.D. ) |
Study ID Numbers: | 00-095 |
Study First Received: | December 26, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00588185 |
Health Authority: | United States: Food and Drug Administration |
Progressive Prostate Cancer |
Testosterone Prostatic Diseases Genital Neoplasms, Male Deoxyglucose Dihydrotestosterone |
Urogenital Neoplasms Methyltestosterone Genital Diseases, Male Prostatic Neoplasms Testosterone 17 beta-cypionate |
Antimetabolites Anti-Infective Agents Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiviral Agents Hormones Pharmacologic Actions Androgens |