[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate or Salivary Gland Cancer
About this study
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.
- Condition
- Prostate Cancer
- Tested
- [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
- Sponsor
- Memorial Sloan Kettering Cancer Center
Who can join
- Age
- Not specified
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 16
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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)
Exclusion 8
- 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
- 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.
Where
7 sites, 7 recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
and 1 more site on ClinicalTrials.gov
Contact
-
Heiko Schoder, MD
212-639-8001
-
Michael Morris, MD, PhD
646-422-4469
Potential match only. Final eligibility is determined by the study team.