Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

PET Scan in Treating Patients With Metastatic Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Diagnostic	Closed	Not specified	NCI	MSKCC-97007 NCI-G97-1232, NCT00002981

Objectives

1. 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.
2. 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.
3. 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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• Not specified

Performance status:

• Karnofsky greater than 60%

Hematopoietic:

• ANC greater than 1,000/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

Approximately 100 will be accrued.

Outcomes

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

Outline

Two cohorts of patients are evaluated: those with tumors that are proliferating despite castrate levels of testosterone (androgen independent) and those that are proliferating in the setting of noncastrate testosterone levels (hormone naive or intermittent therapy).

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 Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Steven M. Larson, MD, Protocol chair		Ph: 212-639-7373; 800-525-2225

Registry Information
Official Title		11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients with Progressive Prostate Cancer
Trial Start Date		1997-01-30
Registered in ClinicalTrials.gov		NCT00002981
Date Submitted to PDQ		1997-04-08
Information Last Verified		2007-04-29
NCI Grant/Contract Number		CA08748

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