An official website of the United States government
Fludeoxyglucose F-18 and Fluorine F18 FDHT Positon Emission Tomography in Treating Patients with Progressive Prostate Cancer or Locally Advanced, Unresectable, or Metastatic Salivary Gland Cancer
Trial Status: active
This clinical trial studies how well fludeoxyglucose F-18 (18FDG) and fluorine F18 16-beta-fluoro-5-alpha-dihydrotestosterone (18FDHT) positron emission tomography (PET) works in treating patients with prostate cancer that is growing, spreading, or getting worse (progressive) and salivary gland cancer that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). A PET scan is a procedure in which a small amount of radioactive glucose (radiotracer) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because tumor cells often take up more glucose than normal cells, the pictures can be used to find tumor cells in the body. A radiotracer is a drug that
carries a small amount of radiation that can be seen on the scan. Two radiotracer drugs will be used in this study. The first is a drug called FDG. It is a sugar that many living cells need for energy. The second is a radiotracer called
FDHT that targets a protein called the “androgen receptor,” which is present in prostate cancer and other cells. FDG and FDHT PET may help locate tumor cells and learn what they use to grow to improve treatment in patients with progressive prostate cancer or locally advanced, unresectable, or metastatic salivary gland cancer.
Inclusion Criteria
PROSTATE CANCER: Patients with histologically confirmed prostate cancer
PROSTATE CANCER: Progressive disease manifest by either:
* Imaging modalities:
** Scintigraphy or sodium fluoride (NaF) PET scan and/or magnetic resonance imaging (MRI) or computed tomography (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
*** An increase in measurable soft tissue disease, or the appearance of new sites of disease OR A minimum of three rising prostate-specific antigen (PSA) values from a baseline that are obtained 1 week or more apart, or 2 or more weeks apart
* PSA changes:
** Androgen-independent, minimum number of determinations 3, interval >= 1 week, percentage increase over 25%
** Androgen-independent, minimum number of determinations 2, interval >= 2 week, percentage increase over 25%
PROSTATE CANCER: Visible lesions by either CT, bone imaging, or MRI consistent with disease
PROSTATE CANCER: Informed consent
SALIVARY GLAND CANCERS: Histologically proven diagnosis of salivary cancer with AR expression detected
by immunohistochemistry
SALIVARY GLAND CANCERS: Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria
SALIVARY GLAND CANCERS: Locally advanced/unresectable (as determined by local surgeon) OR metastatic
disease
SALIVARY GLAND CANCERS: Age ≥ 18 years
SALIVARY GLAND CANCERS: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
SALIVARY GLAND CANCERS: AST/ALT < 3 x ULN
SALIVARY GLAND CANCERS: 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
PROSTATE CANCER: Previous anaphylactic reaction to either FDHT or FDG
PROSTATE CANCER: Bilirubin > 1.5 x upper limit of normal (ULN)
PROSTATE CANCER: Gamma-glutamyl transpeptidase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULN
PROSTATE CANCER: Creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min
SALIVARY GLAND CANCERS: Uncontrolled or untreated brain metastases
SALIVARY GLAND CANCERS: Class 3 or 4 congestive heart failure
SALIVARY GLAND CANCERS: Uncontrolled hypertension (systolic blood pressure [BP] > 170 mmHg or diastolic BP > 105 mmHg at screening)
SALIVARY GLAND CANCERS: Vascular or ischemic event within 6 months of study registration
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00588185.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Heiko Schoder
Phone: 212-639-8001
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Heiko Schoder
Phone: 212-639-8001
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Heiko Schoder
Phone: 212-639-8001
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Heiko Schoder
Phone: 212-639-8001
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Heiko Schoder
Phone: 212-639-8001
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Heiko Schoder
Phone: 212-639-8001
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Heiko Schoder
Phone: 212-639-8001
PRIMARY OBJECTIVES:
I. To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer and salivary gland cancers..
II. To define the relationship between FDHT uptake and tumor diffusivity as assessed by magnetic resonance imaging (MRI).
III. To preliminarily determine the relationship between FDHT uptake and tissue analyses of androgen receptor (AR) expression (tissue will not be acquired under this protocol).
IV. To correlate the accumulation of 18FDHT to 18FDG.
V. To study changes in 18FDHT accumulation over time in patients treated with AR-targeting therapies and chemotherapy.
OUTLINE:
Patients receive 18FDG intravenously (IV) and undergo PET imaging over 60-75 minutes on day 1. Patients then receive fluorine 18FDHT IV and undergo PET imaging on day 2. Some patients will only receive 18FDG or 18FDHT IV and undergo PET imaging on day 1. Courses repeat at weeks 4 and 12, and every 12 weeks for up to 8 FDHT/FDG scan sets in 12 months. Additionally, patients undergo blood sample collection, bone scan, and computed tomography (CT) or MRI at screening.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
