PET Scan in Treating Patients With Metastatic Prostate Cancer
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Purpose
RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or recurrent prostate cancer.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: methionine C 11 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | 11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer |
- Pharmacokinetics [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Metabolism [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 173 |
| Study Start Date: | January 1997 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PET Scan
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.
|
Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: methionine C 11 |
Detailed 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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Steven M. Larson, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002981 History of Changes |
| Other Study ID Numbers: | 97-007, P30CA008748, MSKCC-97007, NCI-G97-1232 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013