Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-04 @ 5:30 PM
Study NCT ID:
NCT03238066
Status:
UNKNOWN
Last Update Posted:
2018-06-07
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy
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': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 77}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-06', 'studyFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2017-07-31', 'lastUpdatePostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of late GI/GU grade 3 and more toxicities', 'timeFrame': 'up to 60 Months in Follow up'}], 'secondaryOutcomes': [{'measure': 'Rate of acute GI/GU treatment-related adverse events', 'timeFrame': 'up to 24 months after start of recruitment'}, {'measure': 'Time to biochemical failure', 'timeFrame': 'up to 60 Months in Follow up', 'description': 'defined rise of PSA'}, {'measure': 'Overall survival', 'timeFrame': 'up to 60 Months in Follow up'}, {'measure': 'Disease-free survival', 'timeFrame': 'up to 60 Months in Follow up'}, {'measure': 'Disease-specific survival', 'timeFrame': 'up to 60 Months in Follow up'}, {'measure': 'Clinical patterns of tumor recurrence', 'timeFrame': 'up to 60 Months in Follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.', 'detailedDescription': 'Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy:\n\nSalvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22, 43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31) Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs should not exceed 43˚C'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically-confirmed locally recurrent prostate cancer - biopsy performed \\< 6 months before registration;\n* Histology: Adenocarcinoma, every Gleason score (2-10)\n* Initial treatment (EBRT) completed \\> 24 months prior to biopsy;\n* Androgen deprivation therapy for prostate cancer should be discontinued at least 3 months prior to patient registration\n* Staging performed within 12 weeks prior to registration:\n\n * Local stage evaluated by DRE, TRUS or - if necessary - mpMRI (T1b, T1c, T2a, T2b, T2c, T3a, T3b);\n * Negative lymph nodes by imaging studies (at least one of these: choline PET scan, pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0);\n * Negative bone scan (M0);\n* PSA-DT \\> 6 months (PSA measurements taken of the 12 months prior to registration)\n* Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS) \\< 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers;\n* Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.\n\nIn TRUS volume study performed 0-4 weeks before registration patient meets eligibility criteria for prostate brachytherapy as follows:\n\n* Prostate/tumor volume \\<60ml\n* The distance rear prostate edge - rectal mucosa \\>5mm\n* Interference of pubic arch ruled out\n* If local stage T3b: it must be possible to cover by the brachytherapy dose cancer infiltration\n\n * Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for 915 MHz frequency antennas)\n * The patient is suitable for spinal or general anesthesia\n * Age \\> 18 y.\n * Life expectancy \\> 5 years\n * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n * The patient must sign a study-specific informed consent form before study registration\n\nExclusion Criteria:\n\n* Severe, active comorbidities:\n\n * Decompensated congestive heart disease\n * Chronic obstructive pulmonary disease exacerbation, respiratory failure\n * Hepatic insufficiency resulting in coagulation defects or clinical jaundice\n* Other active malignancy or treatment of invasive or hematological malignancy\n* Evidence of extraprostatic disease at local recurrence:\n\n * Local stage T4\n * Histologic or radiologic evidence of lymph node metastases (N1 or pN1)\n * Presence of distant metastases (M1)\n* Any of the following prior therapies:\n\n * TURP within 6 months prior to registration\n * Prostatic salvage cryosurgery performed at least 6 months before registration\n * HIFU performed at least 6 months before registration\n * Androgen deprivation therapy within 3 months prior to registration\n* Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.'}, 'identificationModule': {'nctId': 'NCT03238066', 'acronym': 'Prostata-BT-HT', 'briefTitle': 'Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy', 'orgStudyIdInfo': {'id': 'Prostata-BT-HT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'The physician can choose either HDR or PDR brachytherapy.\n\nIf HDR BT is chosen:\n\nd1: hyperthermia (IHT) 60 minutes + 10Gy HDR brachytherapy (HDRBT) d22: IHT 60 minutes + 10 Gy HDRBT d43: IHT 60 minutes + 10 Gy HDRBT\n\nIf PDR BT is chosen:\n\nd1-3: IHT 60 minutes + 30Gy PDRBT d29-31: IHT 60 minutes + 30Gy PDRBT', 'interventionNames': ['Radiation: Brachytherapy', 'Other: Hyperthermia']}], 'interventions': [{'name': 'Brachytherapy', 'type': 'RADIATION', 'description': 'HDR/PDR brachytherapy', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Hyperthermia', 'type': 'OTHER', 'description': 'Interstitial hyperthermia', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Vratislav Strnad, MD', 'role': 'CONTACT', 'email': 'vratislav.strnad@uk-erlangen.de', 'phone': '++49(0)9131-85', 'phoneExt': '33419'}], 'facility': 'Strahlenklinik im Universitaetsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '31-826', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Andrzej Kukielka, MD', 'role': 'CONTACT'}], 'facility': 'Centrum Radiotherapii', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '02-034', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Mateusz Dabkowski, MD', 'role': 'CONTACT'}], 'facility': 'Maria Sklodowska-Curie Institute - Oncology Center', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Vratislav Strnad, MD', 'role': 'CONTACT', 'email': 'vratislav.strnad@uk-erlangen.de', 'phone': '++49(0)9131-85', 'phoneExt': '33419'}, {'name': 'Studiensekretariat', 'role': 'CONTACT', 'email': 'st-studiensekretariat@uk-erlangen.de', 'phone': '++49(0)9131-85', 'phoneExt': '33968'}], 'overallOfficials': [{'name': 'Vratislav Strnad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Medical Director of the Dept. of Radiooncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Medical Director of the Dept. of Radiooncology', 'investigatorFullName': 'Vratislav Strnad', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}