Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
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.
Interventions
PROCEDUREpositron emission tomography
RADIATIONfludeoxyglucose F 18
RADIATIONmethionine C 11
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
0 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 9 years | — |
| Metabolism | 3 years | — |
| Percentage of Unbiopsied Lesions That Are Confirmed Positive | 3 years | Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
positron emission tomography
fludeoxyglucose F 18
methionine C 11 | 173 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inevaluable | 6 |
Baseline characteristics
| Characteristic | PET Scan |
|---|---|
| Age, Continuous | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 160 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 160 Participants |
| Region of Enrollment United States | 173 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 156 / 173 |
| other Total, other adverse events | 0 / 173 |
| serious Total, serious adverse events | 2 / 173 |
Outcome results
Primary
Metabolism
Time frame: 3 years
Population: N/A data were not collected
Primary
Overall Survival
Time frame: Up to 9 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PET Scan | Overall Survival | 91.6 weeks |
Primary
Percentage of Unbiopsied Lesions That Are Confirmed Positive
Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PET Scan | Percentage of Unbiopsied Lesions That Are Confirmed Positive | 98 percentage of lesions |