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

Recruiting

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

Who can join

All ages · Men

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 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.

About the 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.

What is being tested

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 300 · Started: 2003-02

Contact the study team

Official record on ClinicalTrials.gov — NCT00588185

Locations in the U.S.

New JerseyMemorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge
Memorial Sloan Kettering Monmouth (Consent only), Middletown
Memorial Sloan Kettering Bergen (Consent Only), Montvale
New YorkMemorial Sloan Kettering Commack (Consent only), Commack
Memorial Sloan Kettering Westchester (Consent only), Harrison
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Nassau (Consent Only), Uniondale

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.