Clinical trial NCT00002981: PET Scan in Treating Patients With Metastatic Prostate Cancer
Official title: 11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 173
Sex: MALE
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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 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

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 9 years
measure: Metabolism
timeFrame: 3 years
measure: Percentage of Unbiopsied Lesions That Are Confirmed Positive
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven M. Larson, MD
role: STUDY_CHAIR
References: