[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate or Salivary Gland Cancer
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer or Salivary Gland Cancer
About This Trial
- This study is testing whether specialized imaging scans, known as PET scans, can do a better job of finding where prostate cancer may have spread in the body.
- It is designed for people with confirmed prostate cancer that is getting worse, which may be shown by rising PSA levels or new signs of disease on recent scans.
- Before considering this study, patients should know that their liver and kidneys must be working properly to participate safely.
- Additionally, you cannot take part if you have ever had a severe allergic reaction to the specific imaging dyes used during these scans.
More Information
- 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.
Who Can Enroll
- Gender: Male
- Who This Trial is For: This study is testing whether specialized imaging scans, known as PET scans, can do a better job of finding where prostate cancer may have spread in the body.
Study Details
- Start Date: February 2003
- Lead Sponsor: Memorial Sloan Kettering Cancer Center
Full 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 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN
- Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min Salivary Gland Cancers
Inclusion Criteria
- Histologically proven diagnosis of salivary cancer with AR expression detected by immunohistochemistry
- Measurable disease as defined by RECIST v1.1 criteria
- Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
- Age ≥ 18 years
- ECOG performance status 0 or 1
- AST/ALT 170 mmHg or diastolic BP >105 mmHg at screening)
- Vascular or ischemic event within 6 months of study registration.
Treatments
- Drug: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone