[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 7, 2008

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to use special imaging tests called PET scans to find out how prostate cancer may be spreading in patients. The scans use a small amount of a radioactive substance to help doctors see changes in the body that might indicate where the cancer has moved. Specifically, the study will look at two types of PET scans—one that tracks sugar metabolism and another that looks for testosterone levels—to determine which might be more effective in spotting advanced prostate cancer.

To participate in this study, patients need to have a confirmed diagnosis of prostate cancer that is getting worse, which can be shown through imaging tests or rising blood test results called PSA levels. The trial is open to male patients, and those interested will need to provide informed consent to join. Participants can expect to undergo PET scans as part of the study, which will help researchers learn more about the best ways to detect and monitor prostate cancer progression. It's important to note that there are some health criteria that could exclude a patient from joining, such as certain liver or kidney problems, or previous severe allergic reactions to the substances used in the scans.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients with histologically confirmed prostate cancer.
• * Progressive disease manifest by either:
• * Imaging modalities:
• • Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET 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 imaging, or MRI consistent with disease.
• • Informed consent.
• Exclusion Criteria:
• • Previous anaphylactic reaction to either FDHT 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