Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 6:31 PM
Study NCT ID:
NCT02761135
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biopsy cores from prostate.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer detection', 'timeFrame': 'Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.', 'description': 'After finished study inclusion, data will be analyzed and presented within 12-18 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Biopsy technique', 'Transrectal ultrasonography probe', 'Side-fire', 'Prostate cancer', 'End-fire'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '31204873', 'type': 'DERIVED', 'citation': 'Ortegren J, Holmberg JT, Lekas E, Mana S, Martensson S, Richthoff J, Sundqvist P, Kjolhede H, Bratt O, Liedberg F. A randomised trial comparing two protocols for transrectal prostate repeat biopsy: six lateral posterior plus six anterior cores versus a standard posterior 12-core biopsy. Scand J Urol. 2019 Aug;53(4):217-221. doi: 10.1080/21681805.2019.1628102. Epub 2019 Jun 17.'}]}, 'descriptionModule': {'briefSummary': "Prostate cancer is the most common cancer among men in Sweden. During investigation of suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to diagnosis.\n\nThe most common technique today is side-fire where the needle enter the prostate in angle from the probe. In end-fire technique the needle enters the prostate at tip of probe without angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach the ventral and apical aspects of prostate.\n\nToday´s standard is at least five cores from each side of the prostate at first biopsy. If first sample is negative there will usually be another urological exam and a first re-biopsy.\n\nThe study aim to compare these two methods in cancer detection. The investigators' hypothesis is that when using end-fire technique at first re-biopsy, investigators find more cancers compared to side-fire.\n\nPatients are prospectively randomized into two groups, both assessing 12 core biopsies according to study protocol.\n\nPrimary endpoint is cancer detection. Data will be collected about patient age, PSA-level, prostate size, digital rectal exam, hypoechogenic zones and length of cancers."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men admitted to Urological reception in Vaxjo and Ljungby for a first-time re-biopsy for investigating prostate cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first re-biopsy\n* PSA over 3ng/ml\n* T1c to T2a palpatory finding\n\nExclusion Criteria:\n\n* prostate cancer\n* T2b or more advanced cancer\n* more than one previous biopsy done'}, 'identificationModule': {'nctId': 'NCT02761135', 'briefTitle': 'Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kronoberg County Council'}, 'officialTitle': 'Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique, in Investigating a Raised Prostatic Specific Antigen (PSA)?', 'orgStudyIdInfo': {'id': 'Endfirestudie'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Side-fire', 'description': 'Using side-fire technique during transrectal ultrasound.'}, {'label': 'End-fire', 'description': 'Using end-fire technique during transrectal ultrasound.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vaxjo', 'state': 'Kronoberg County', 'country': 'Sweden', 'facility': 'Section of Urology, Department of surgery, Regional Hospital Växjö', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}], 'overallOfficials': [{'name': 'Joakim Ortegren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kronoberg County Council', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}