Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 3:27 AM
Study NCT ID:
NCT00032058
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2002-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-04', 'lastUpdateSubmitDate': '2011-02-18', 'studyFirstSubmitDate': '2002-03-08', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Compare the incremental benefit of these tests on diagnostic accuracy in these patients.\n* Compare the incremental benefit of MRSI for interobserver agreement vs MRI alone in the localization of prostate cancer in these patients.\n* 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.\n\nOUTLINE: This is a multicenter study.\n\nAt 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.\n\nPROJECTED ACCRUAL: A total of 134 patients will be accrued for this study within 7 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage I-II adenocarcinoma of the prostate\n\n * At least 6 weeks since prior biopsy\n* Scheduled to undergo radical prostatectomy within 6 months of MRI and magnetic resonance spectroscopic imaging (MRSI)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nCardiovascular:\n\n* No cardiac pacemakers\n\nOther:\n\n* Must be willing and able to undergo MRI/MRSI\n* No allergy to latex\n* No contraindications to MRI such as non-compatible intracranial vascular clips\n* No metallic hip implant or any other metallic implant or device that would compromise quality of MRI/MRSI\n* No contraindications to or intolerance of endorectal coil insertion (e.g., prior abdominoperineal resection of the rectum or Crohn's disease)\n* No general medical or psychiatric condition or physiologic status unrelated to prostate cancer that would preclude valid informed consent\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior BCG for bladder cancer\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No prior androgen-deprivation therapy\n\nRadiotherapy:\n\n* No prior prostatic or rectal radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* No prior cryosurgery\n* No prior surgery for prostate cancer\n* No prior transurethral resection of the prostate (TURP)\n* No prior rectal surgery\n\nOther:\n\n* No prior complementary alternative medicine"}, 'identificationModule': {'nctId': 'NCT00032058', 'briefTitle': 'Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study', 'orgStudyIdInfo': {'id': 'CDR0000069254'}, 'secondaryIdInfos': [{'id': 'ACRIN-6659'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'magnetic resonance imaging', 'type': 'PROCEDURE'}, {'name': 'magnetic resonance spectroscopic imaging', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143-0628', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Comprehensive Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jeffrey Weinreb, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American College of Radiology Imaging Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}