NCT00002981

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 1997

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
20.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 3, 2024

Completed
Last Updated

June 3, 2024

Status Verified

June 1, 2023

Enrollment Period

26.5 years

First QC Date

November 1, 1999

Results QC Date

March 11, 2024

Last Update Submit

May 31, 2024

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancerrecurrent prostate cancer

Outcome Measures

Primary Outcomes (3)

  • Overall Survival

    Up to 9 years

  • Metabolism

    3 years

  • 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

Study Arms (1)

PET Scan

EXPERIMENTAL

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.

Procedure: positron emission tomographyRadiation: fludeoxyglucose F 18Radiation: methionine C 11

Interventions

positron emission tomographyPROCEDURE
PET Scan
fludeoxyglucose F 18RADIATION
PET Scan
methionine C 11RADIATION
PET Scan

Eligibility Criteria

Age0 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18carbon-11 methionine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Results Point of Contact

Title
Dr. Steven Larson, MD
Organization
Memorial Sloan Kettering Cancer Center
LarsonS@MSKCC.ORG
212-639-7373

Study Officials

  • Steven M. Larson, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1997

Primary Completion

June 12, 2023

Study Completion

June 12, 2023

Last Updated

June 3, 2024

Results First Posted

June 3, 2024

Record last verified: 2023-06

Locations

US(1)