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

PURPOSE: This phase II/III trial is studying how well PET scans work in detecting cancerous changes in patients with metastatic prostate cancer.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer	Drug: fludeoxyglucose F 18  Drug: methionine C 11  Procedure: diagnostic test  Procedure: tomography, emission computed	Phase II Phase III

Further Study Details: 

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.

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.

PROJECTED ACCRUAL: Approximately 100 will be accrued.

Genders Eligible for Study:  Both

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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Steven M. Larson, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000065504; MSKCC-97007; NCI-G97-1232; NCT00002981
Record last reviewed:  November 1997
Last Updated:  February 7, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002981
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08