NCT00032058

Brief Summary

RATIONALE: Imaging procedures such as magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) may improve the ability to detect the extent of prostate cancer. It is not yet known if MRI combined with MRSI is more effective than MRI alone in detecting the extent of prostate cancer. PURPOSE: Diagnostic trial to compare the effectiveness of combining MRI with MRSI to that of MRI alone in determining the extent of prostate cancer in patients who are scheduled to undergo surgery to remove the prostate gland.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

February 21, 2011

Status Verified

April 1, 2005

Enrollment Period

3 years

First QC Date

March 8, 2002

Last Update Submit

February 18, 2011

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage IIB prostate cancerstage IIA prostate cancer

Interventions

magnetic resonance imagingPROCEDURE
magnetic resonance spectroscopic imagingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage I-II adenocarcinoma of the prostate * At least 6 weeks since prior biopsy * Scheduled to undergo radical prostatectomy within 6 months of MRI and magnetic resonance spectroscopic imaging (MRSI) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No cardiac pacemakers Other: * Must be willing and able to undergo MRI/MRSI * No allergy to latex * No contraindications to MRI such as non-compatible intracranial vascular clips * No metallic hip implant or any other metallic implant or device that would compromise quality of MRI/MRSI * No contraindications to or intolerance of endorectal coil insertion (e.g., prior abdominoperineal resection of the rectum or Crohn's disease) * No general medical or psychiatric condition or physiologic status unrelated to prostate cancer that would preclude valid informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior BCG for bladder cancer Chemotherapy: * Not specified Endocrine therapy: * No prior androgen-deprivation therapy Radiotherapy: * No prior prostatic or rectal radiotherapy Surgery: * See Disease Characteristics * No prior cryosurgery * No prior surgery for prostate cancer * No prior transurethral resection of the prostate (TURP) * No prior rectal surgery Other: * No prior complementary alternative medicine

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

Sponsors & Collaborators

Study Sites (8)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0628, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jeffrey Weinreb, MD

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
NETWORK

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

June 1, 2003

Primary Completion

June 1, 2006

Last Updated

February 21, 2011

Record last verified: 2005-04

Locations

US(8)