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11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose 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

11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer


OBJECTIVES:

- Measure the pharmacokinetics, whole body retention of isotope, and biodistribution of
C11-methionine and FDG by PET imaging and serial sampling of blood in men with
progressive prostate cancer.

- Explore metabolism of each PET scan by comparing the sensitivity of C11-methionine or
FDG by PET scanning in androgen independent prostate cancer metastases with the
sensitivity of C11-methionine or FDG in androgen dependent metastases on a site by site
basis.

- Compare C11-methionine and FDG PET scanning to standard of care diagnostic studies
which include the Tc 99m bone scan, computed tomography, and magnetic resonance
imaging.

Patients fast for 6 hours prior to PET imaging with the exception of liberal water intake
which is encouraged. A two way catheter is placed in the urinary bladder, and continuous
isotonic saline irrigation is performed throughout scan acquisition to reduce the
interference in imaging lesions in the pelvic lymph nodes and adjacent pelvic bones caused
by radiation excreted in urine held in the bladder.

Each patient receives C11-methionine intravenously. PET imaging begins immediately after
injection for approximately 60 minutes total using standard imaging procedures. Immediately
following the completion of imaging after C11-methionine administration, each patient
receives FDG intravenously. PET imaging begins approximately 45 minutes thereafter for
approximately 60 minutes using standard imaging procedures.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate adenocarcinoma

- Must have an at least 50% increase in PSA which is sustained for a minimum of 3
observations obtained at least 1 week apart

- Must have development of new lesions on bone scintigraphy or greater than 50%
increase in measurable disease on CT or MRI scan

- Metastatic disease

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Karnofsky greater than 60%

Hematopoietic:

- ANC greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No clinically significant cardiac disease

Pulmonary:

- No clinically significant pulmonary disease

Other:

- No active infection not controlled by antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetics

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Steven M. Larson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

97-007

NCT ID:

NCT00002981

Start Date:

January 1997

Completion Date:

April 2014

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021