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

Prior treatment

• Previous anaphylactic reaction to either FDHT or FDG

Other illness

• Class 3 or 4 congestive heart failure
• Uncontrolled hypertension (systolic BP \>170 mmHg or diastolic BP \>105 mmHg at screening)

Lab values

• 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
  • Salivary Gland Cancers

Other

• Uncontrolled or untreated brain metastases
• Vascular or ischemic event within 6 months of study registration.

• 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.
• 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 \< 3xULN
• No prior AR-targeted therapy (Exception: AR-targeted therapy administered in the adjuvant setting and with disease recurrence more than 6 months since treatment completion)