Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-02 @ 11:48 AM
Study NCT ID:
NCT02391051
Status:
RECRUITING
Last Update Posted:
2017-08-11
First Post:
2014-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2014-07-01', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity and frequency of adverse events', 'timeFrame': '6 weeks after therapy'}], 'secondaryOutcomes': [{'measure': 'Tumor regression', 'timeFrame': '6 weeks up to 10 years after therapy'}, {'measure': 'Rate of recurrences measured by PSA', 'timeFrame': '10 years after therapy'}, {'measure': 'Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival', 'timeFrame': '10 years after therapy'}, {'measure': 'Correlation of microRNA141 and -375 with outcome', 'timeFrame': '10 years after therapy'}, {'measure': 'Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ', 'timeFrame': '6 weeks after therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'focal brachytherapy', 'PSA', 'Biological marker'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.', 'detailedDescription': 'Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Histologically confirmed prostate cancer\n* Gleason Score of index lesion ≤ 6 (3+3)\n* Tumor stage: cT1-2a cN0 cM0\n* Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.\n* PSA ≤ 10/ng/ml\n* Prostate volume \\< 60 m\\^3\n* No distant metastasis\n* Life expectancy \\> 10 years\n* Informed consent\n\nExclusion Criteria:\n\n* Tumor stage ≥ T2b\n* Known metastasis: N+ and/or M1\n* General anesthesia or peridural anesthesia is not possible\n* Coagulation disorder'}, 'identificationModule': {'nctId': 'NCT02391051', 'acronym': 'FOKAL-BT', 'briefTitle': 'Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial', 'orgStudyIdInfo': {'id': 'FOKAL-BT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Focal Brachytherapy', 'description': 'HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy', 'interventionNames': ['Radiation: HDR-Brachytherapy']}], 'interventions': [{'name': 'HDR-Brachytherapy', 'type': 'RADIATION', 'description': 'HDR-Brachytherapy 2x 13,5 Gy', 'armGroupLabels': ['Focal Brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Vratislab Strnad, MD', 'role': 'CONTACT', 'email': 'st-studiensekretariat@uk-erlangen.de', 'phone': '++49-9131-85', 'phoneExt': '33968'}, {'name': 'Vratislav Strnad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Vratislav Strnad, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Radiooncology'}, {'name': 'Bastian Keck, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Urology'}, {'name': 'Alexander Cavallaro, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Radiology'}, {'name': 'Arndt Hartmann, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Pathology'}, {'name': 'Michael Lotter, Dipl.-Phys.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Radiooncology'}, {'name': 'Annedore Strnad, MD, MHBA', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Radiooncology'}, {'name': 'Peter Goebell, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Urology'}, {'name': 'Wolfgang Uter, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Erlangen; Dept. of Biometrics and Epidemiology'}, {'name': 'Michael Uder, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Radiology'}, {'name': 'Bernd Wullich, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Urology'}, {'name': 'Rainer Fietkau, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Erlangen, Dept. of Radiooncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}