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PET Scan in Treating Patients With Metastatic Prostate Cancer



PET Scan in Treating Patients With Metastatic Prostate Cancer

For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or recurrent prostate cancer. PURPOSE: Diagnostic trial to study the effectiveness of PET scans in treating patients with metastatic prostate cancer.
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.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StevenLarson,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Howard  Scher 646-422-4323


Additional Information:
Study ID Numbers:
  CDR0000065504;  MSKCC-97007,NCI-G97-1232
Study Start Date: 
Record last reviewed: November 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002981

Other Stage 4 Prostate Cancer Studies:
1. BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer

2. Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy

3. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

4. Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer

5. Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer

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