[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
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.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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.
Baseline, 4 weeks and 12 weeks
Michael Morris, M.D., Ph.D.
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|