PET Scan in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002981
• Other study ID #: 97-007
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: N/A
• Start date: January 1997
• Est. completion date: June 12, 2023

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 0 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• positron emission tomography

Radiation:
• fludeoxyglucose F 18

• methionine C 11

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Up to 9 years
Primary	Metabolism		3 years
Primary	Percentage of Unbiopsied Lesions That Are Confirmed Positive	Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods	3 years

External Links

•   Memorial Sloan Kettering Cancer Center