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Home > "M" Clinical Trials Conditions > Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer  Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
For Condition: stage 2 prostate cancer,stage 1 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): American College of Radiology Imaging Network , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyWeinreb, Study Chair, Yale University
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-0628
United States
Recruiting Fergus Coakley 415-353-1786
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Akira Kawashima 507-284-2511
Brigham and Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Clare Tempany 617-732-7858
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Katarzyna Macura 410-955-5391
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Mark Rosen 215-662-3107
Yale University School of Medicine *Recruiting*
New Haven, Connecticut, 06520
United States
Recruiting Jeffrey Weinreb 203-785-5913
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Haesun Choi 713-745-4693
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Steve Eberhardt 212-794-4010
Additional Information:
Study ID Numbers: CDR0000069254; ACRIN-6659
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032058
Other Stage 1 Prostate Cancer Studies:
1. Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
2. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
3. Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
4. External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer
5. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
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