Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments positron emission tomography, fludeoxyglucose f 18, methionine c 11
Sponsor Memorial Sloan-Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date January 1997
End date April 2016
Trial size 173 participants
Trial identifier NCT00002981, 97-007, MSKCC-97007, NCI-G97-1232, P30CA008748

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
positron emission tomography
fludeoxyglucose f 18
methionine c 11

Primary Outcomes

Measure
Pharmacokinetics
time frame: 3 years
Metabolism
time frame: 3 years
Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods
time frame: 3 years

Eligibility Criteria

Male participants of any age.

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

Additional Information

Official title 11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan-Kettering Cancer Center.