Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-17 @ 9:01 AM
Study NCT ID:
NCT01347320
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Magnetic Resonance (MR) Imaging of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-27', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical margins', 'timeFrame': '30 days', 'description': 'The surgical margins are assessed by evaluating the pathological specimen'}], 'secondaryOutcomes': [{'measure': 'Surgical decision process', 'timeFrame': '30 days', 'description': 'Evaluated using questionaire'}, {'measure': 'Preoperative TNM classification', 'timeFrame': '1-4 weeks', 'description': 'Based upon preoperative MRI'}, {'measure': 'Detection of Gleason grade 4 and 5', 'timeFrame': '30 days'}, {'measure': 'Functional outcome', 'timeFrame': '1 year after prostatectomy', 'description': 'Evaluate the functional outcome in respect to erectile dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate cancer', 'preoperative staging', 'MRI', 'Free surgical margins'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '25813692', 'type': 'DERIVED', 'citation': 'Rud E, Baco E, Klotz D, Rennesund K, Svindland A, Berge V, Lundeby E, Wessel N, Hoff JR, Berg RE, Diep L, Eggesbo HB, Eri LM. Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial? Eur Urol. 2015 Sep;68(3):487-96. doi: 10.1016/j.eururo.2015.02.039. Epub 2015 Mar 23.'}, {'pmid': '25059766', 'type': 'DERIVED', 'citation': 'Rud E, Klotz D, Rennesund K, Baco E, Johansen TE, Diep LM, Svindland A, Eri LM, Eggesbo HB. Preoperative magnetic resonance imaging for detecting uni- and bilateral extraprostatic disease in patients with prostate cancer. World J Urol. 2015 Jul;33(7):1015-21. doi: 10.1007/s00345-014-1362-x. Epub 2014 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to evaluate if preoperative MRI improves the surgical results, especially in respect to surgical margins. The impact on the surgical procedure will be evaluated.\n\nIn addition the investigators will examine the accuracy of tumor detection, localization and staging.', 'detailedDescription': 'Background:\n\nDuring the last two decades, Magnetic Resonance Imaging (MRI) of the prostate has evolved to become a promising tool in preoperative evaluation of prostate cancer. Several studies have evaluated the radiological and histopathological correlation. However, the sensitivity and specificity in regard to staging have shown wide ranges and poor reproducibility. These discrepancies can be explained by difference in patient selection, MRI methods, and criteria used for diagnosis. More studies are therefore needed to evaluate the clinical impact of preoperative MRI in patients with prostate cancer.\n\nAims of the study:\n\nTo evaluate 1) detection rate of tumor 1-3 (tumor 1 = index tumor), size of tumor 1-3, possible extraprostatic extension and predict presence of Gleason grade 4 and 5 tumor, 2) the influence of preoperative MRI on the surgical decision process with respect to the operative procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of preoperative MRI on the rate of positive surgical margins and functional results.\n\nMaterial and method:\n\nA prospective study including 400 consecutive patients referred to robot assisted laparoscopic prostatectomy randomised to preoperative MRI (intervention group) and no MRI (control group). The prostatectomy specimens will be histopathologically examined, and TNM classification will be performed according to 2002 AJCC standard.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* All patients suitable for surgery.\n* Positive biopsy (Gleason grade \\>3).\n* Informed consent.\n\nExclusion Criteria:\n\n* Patients who do not sign the consent paper for any reason or do not accept the study premises.\n* Patents who want to withdraw for any reason during the study.\n* Patients with contraindications to MRI (pacemaker, claustrophobia etc) and/or surgery.\n* Patients who have undergone a high quality MRI examination of the prostate at another radiological center. In this situation the MR examination is evaluated together with the surgeon but the patient is not included in the study. (In case of a low quality examinations, we will disregard the findings, and include the patient).\n* If the surgeon finds it unacceptable to perform RALP without MRI, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study.\n* If preoperative MRI reveals extensive tumor invasion into adjacent organ (T4) or skeletal metastases (M1), as these cancer stadiums do not benefit from RALP.'}, 'identificationModule': {'nctId': 'NCT01347320', 'briefTitle': 'Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Clinical Impact of MR Imaging in Patients With Prostate Cancer', 'orgStudyIdInfo': {'id': 'OsloUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No preoperative MRI', 'description': 'control arm of the study'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MRI group', 'description': 'preoperative MRI', 'interventionNames': ['Other: Preoperative MRI']}], 'interventions': [{'name': 'Preoperative MRI', 'type': 'OTHER', 'description': 'Preoperative staging', 'armGroupLabels': ['MRI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0514', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Erik Rud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital, Aker'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Erik Rud', 'investigatorAffiliation': 'Oslo University Hospital'}}}}