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

Summary

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.

Eligibility

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

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 \< 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)

Exclusion Criteria:

* Uncontrolled or untreated brain metastases
* Class 3 or 4 congestive heart failure
* Uncontrolled hypertension (systolic BP \>170 mmHg or diastolic BP \>105 mmHg at screening)
* Vascular or ischemic event within 6 months of study registration.

Conditions2

Locations7 sites

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