PET Scan in Treating Patients With Metastatic Prostate Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: positron emission tomography; Radiation: methionine C 11; Radiation: fludeoxyglucose F 18

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00002981

P30CA008748 (U.S. NIH Grant/Contract)

NCI-G97-1232

97-007

MSKCC-97007

Details and patient eligibility

About

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

Full 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.

Enrollment: 173 patients

Sex: Male

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

173 participants in 1 patient group

PET Scan

Experimental group

Description:

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.

Treatment:

Radiation: fludeoxyglucose F 18

Radiation: methionine C 11

Procedure: positron emission tomography