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OpenTrials
Completed

NCT Number: NCT00002981

PET Scan in Treating Patients With Metastatic Prostate Cancer

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

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Key information

Age range

0 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron Emission Tomography

Procedure

fludeoxyglucose F 18

Radiation

methionine C 11

Radiation

Primary outcomes

  1. Overall Survival

    Time frame: Up to 9 years

  2. Metabolism

    Time frame: 3 years

  3. Percentage of Unbiopsied Lesions That Are Confirmed Positive

    Time frame: 3 years

    Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2003
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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