NCT Number: NCT00032058
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
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.
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Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
UCSF Comprehensive Cancer Center, San Francisco, California, United States
About this study
OBJECTIVES:
- Compare the accuracy of MRI vs MRI combined with magnetic resonance spectroscopic imaging (MRSI) for the localization of prostate cancer prior to radical prostatectomy in patients with stage I or II adenocarcinoma of the prostate.
- Compare the incremental benefit of these tests on diagnostic accuracy in these patients.
- Compare the incremental benefit of MRSI for interobserver agreement vs MRI alone in the localization of prostate cancer in these patients.
- Compare the accuracy of combined MRSI with that of other available information on tumor extent derived from digital rectal exam, PSA level, Gleason score, and Partin nomogram in these patients.
OUTLINE: This is a multicenter study.
At least 6 weeks after biopsy, patients undergo MRI and magnetic resonance spectroscopic imaging (MRSI) over approximately 1 hour. Within 6 months of MRI/MRSI, patients undergo radical prostatectomy.
PROJECTED ACCRUAL: A total of 134 patients will be accrued for this study within 7 months.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
magnetic resonance spectroscopic imaging
ProcedureSponsors and collaborators
Lead sponsor
American College of Radiology Imaging Network
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study
Important dates
- Study start
- 2003
- Primary completion
- 2006
- First posted
- Jan 27, 2003
- Registry last updated
- Feb 21, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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