Trial Outcomes & Findings for PET Scan in Treating Patients With Metastatic Prostate Cancer (NCT NCT00002981)

NCT ID: NCT00002981

Last Updated: 2024-06-03

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

173 participants

Primary outcome timeframe

Up to 9 years

Results posted on

2024-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	173
Overall Study COMPLETED	167
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Inevaluable	6

Baseline Characteristics

PET Scan in Treating Patients With Metastatic Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET Scan n=173 Participants 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
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	173 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	160 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	160 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	173 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 9 years

Outcome measures

Outcome measures
Measure	PET Scan n=173 Participants 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
Overall Survival	91.6 weeks Interval 56.0 to 433.0

PRIMARY outcome

Timeframe: 3 years

Population: N/A data were not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 years

Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods

Outcome measures

Outcome measures
Measure	PET Scan n=2057 Unbiopsied Lesions 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
Percentage of Unbiopsied Lesions That Are Confirmed Positive	98 percentage of lesions

Adverse Events

PET Scan

Serious events: 2 serious events

Other events: 0 other events

Deaths: 156 deaths

Serious adverse events

Serious adverse events
Measure	PET Scan n=173 participants at risk 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
Psychiatric disorders Confusion	0.58% 1/173 • up to 5 years
General disorders Fatigue	0.58% 1/173 • up to 5 years
Renal and urinary disorders Renal Failure	0.58% 1/173 • up to 5 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Steven Larson, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-7373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place