[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer - NCT00588185-10065 (Clinical Trial 197301)
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10065 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- Patients with histologically confirmed prostate cancer.
- Progressive disease manifest by either:
- Imaging modalities:
- Bone Scan: New osseous lesions on bone scan and/or MRI or CT: An increase in
measurable soft tissue disease, or the appearance of new sites of disease. Or
- Biochemical progression: A minimum of three rising PSA values from a baseline that
are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
- Visible lesions by either CT, bone scan, or MRI consistent with disease.
- Informed consent.
Exclusion Criteria:
- Previous anaphylactic reaction to either F18DHT or FDG
- Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin <
2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN
- Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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