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[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, December 2008
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588185
  Purpose

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 Intervention
Prostate Cancer
Other: PET scan

MedlinePlus related topics: Cancer Nuclear Scans Prostate Cancer
Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Dextrose Deoxyglucose Stanolone
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI. [ Time Frame: Baseline, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The kinetics, metabolism, and biodistribution will be assessed. [ Time Frame: Baseline. 4 weeks and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: February 2003
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
PET Scan
Other: PET scan
PET scan performed to assess accumulation and biodistribution of FDHT

Detailed Description:

Our preliminary studies have shown that whole body FDG-PET imaging identifies areas of abnormal metabolism in a majority of tumor sites in patients with progressive disease and that changes in FDG accumulation parallel changes in PSA after treatment. This suggests that changes in FDG metabolism may provide an early assessment of treatment outcomes. In previous work we established a methodology to examine a radiotracer in patients with progressive disease and abnormal imaging studies, which we have applied to the clinical states of non-castrate and castrate metastatic disease. This design is characterized by:

1) Evaluation of uptake on a site-by-site basis in relation to conventional studies 2) Standardization of uptake values in tumor relative to a normal organ 3) Controlling for progression using standard measures of progression including a rising PSA, new or enlarging lesions on bone or transaxial imaging, and new symptoms of disease. In the present study we are evaluating fluorinated dihydrotestosterone (FDHT) in addition to FDG. FDHT is targeted to the AR and has been shown in preliminary studies to visualize prostate cancers in man. This study will apply our established methods to investigate FDHT imaging in patients with progressive prostate cancer. In the selected cases where tumor is available, we will study associations between FDHT accumulation and AR expression.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed prostate cancer.
  • Progressive disease manifest by either:
  • Imaging modalities:
  • Bone Scan: New osseous lesions on bone 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 scan, or MRI consistent with disease.

Exclusion Criteria:

  • Previous anaphylactic reaction to either F18DHT 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588185

Contacts
Contact: Michael Morris, M.D., PH.D. morrism@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Morris, M.D., Ph,D.         morrism@mskcc.org    
Principal Investigator: Michael Morris, M.D., Ph.D.            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Michael Morris, M.D., Ph.D. Memorial Sloan-Kettering Cancer Center
  More Information

Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Michael Morris, M.D. )
Study ID Numbers: 00-095
Study First Received: December 26, 2007
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00588185  
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Progressive Prostate Cancer

Study placed in the following topic categories:
Testosterone
Prostatic Diseases
Genital Neoplasms, Male
Deoxyglucose
Dihydrotestosterone
Urogenital Neoplasms
Methyltestosterone
Genital Diseases, Male
Prostatic Neoplasms
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiviral Agents
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 16, 2009