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PET Scan in Treating Patients With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00002981
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or recurrent prostate cancer.

Condition or disease Intervention/treatment
Prostate Cancer Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: methionine C 11

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer
Study Start Date : January 1997
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PET Scan
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.
Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: methionine C 11



Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 3 years ]
  2. Metabolism [ Time Frame: 3 years ]
  3. Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002981


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Steven M. Larson, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00002981     History of Changes
Other Study ID Numbers: 97-007
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-97007
NCI-G97-1232
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Fluorodeoxyglucose F18
Carbon-11 methionine
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action