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


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

[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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

Baseline, 4 weeks and 12 weeks

Safety Issue:

No

Principal Investigator

Michael Morris, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

00-095

NCT ID:

NCT00588185

Start Date:

February 2003

Completion Date:

February 2014

Related Keywords:

  • Prostate Cancer
  • Progressive Prostate Cancer
  • [18F]-Fluoro-2-Deoxy-D-Glucose
  • [18F] Dihydro-Testosterone
  • Pet Imaging
  • Pet scan
  • 00-095
  • Prostatic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021