Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT01578356
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2012-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-02', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-13', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical recurrence at follow-up.', 'timeFrame': '3 months after prostatectomy', 'description': 'PSA measurement in the serum should not be \\> or = 0,20 ng/ml.'}, {'measure': 'Biochemical recurrence at follow-up', 'timeFrame': '6 months after prostatectomy', 'description': 'PSA measurement in the serum should not be \\> or = 0,20 ng/ml.'}, {'measure': 'Biochemical recurrence at follow-up.', 'timeFrame': '9 months after prostatectomy', 'description': 'PSA measurement in the serum should not be \\> or = 0,20 ng/ml.'}, {'measure': 'Biochemical recurrence at follow-up.', 'timeFrame': '1 year after prostatectomy', 'description': 'PSA measurement in the serum should not be \\> or = 0,20 ng/ml.'}, {'measure': 'Biochemical recurrence at follow-up.', 'timeFrame': '6-monthly follow up between 1 and 5 years after prostatectomy.', 'description': 'PSA measurement in the serum should not be \\> or = 0,20 ng/ml.'}], 'secondaryOutcomes': [{'measure': 'Functional assessment concerning continence.', 'timeFrame': 'after 1, 3, 12 and 24 months', 'description': 'Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.'}, {'measure': 'Functional assessment concerning potency.', 'timeFrame': 'after 1, 3, 12 and 24 months', 'description': 'Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.'}, {'measure': 'Functional assessment concerning quality of life.', 'timeFrame': 'after 1, 3, 12 and 24 months', 'description': 'Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men who were surgically treated or who are being surgically treated for prostate cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prostate cancer\n* radical retropubic prostatectomy or\n* robot-assisted laparoscopic surgery\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01578356', 'briefTitle': 'Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery', 'orgStudyIdInfo': {'id': '2012/122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radical Retropubic prostatectomy (RRP)', 'description': 'Men who underwent open radical prostatectomy in the past at our centre.'}, {'label': 'Robot-assisted laparoscopic prostatectomy (RALP)', 'description': 'Men who undergo robot-assisted laparoscopic prostatectomy at our centre.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Nicolaas Lumen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}