Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-01-02 @ 3:16 PM
Study NCT ID:
NCT07131956
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'wohle blood, prostate tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-08-03', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy', 'timeFrame': 'Blood withdrawal pre-brachytherapy treatment, during surgery, one day after brachytherapy and at the first follow-up visit 4-12 weeks later. Tissue samples at every brachytherapy procedure.', 'description': 'Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy in the primary as well as in the recurrent setting.'}], 'secondaryOutcomes': [{'measure': 'Treatment-related toxicity', 'timeFrame': 'Up to 6 months', 'description': 'Acute toxicity related to brachytherapy'}, {'measure': 'recurrence-free survival', 'timeFrame': 'Up to 6 months', 'description': 'recurrence-free survival'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 6 months', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune-profiling in prostate cancer patients', 'brachytherapy for prostate cancer', 'interstitial brachytherapy for prostate cancer'], 'conditions': ['Prostate Cancer (Diagnosis)', 'Prostate Cancer Patients Who Have Brachytherapy Seed Implant', 'Prostate Cancer Patients Treated by Radiotherapy', 'Prostate Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Prostate cancer patients planning to undergo sole brachytherapy treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Arm 1:\n\n* Primary treatment with I-125 seeds or HDR-BT\n* No previous treatment for prostate cancer\n* Age ≥ 18 years\n\nInclusion Criteria Arm 2:\n\n* HDR- or PDR-BT\n* No radiation therapy within three months before salvage treatment\n* Complete documentation available on previous treatment for prostate cancer\n* No history of prostatectomy\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Pre-existent auto-immune disease\n* patients under bloodthinning medication\n* substance abuse'}, 'identificationModule': {'nctId': 'NCT07131956', 'briefTitle': 'Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)', 'orgStudyIdInfo': {'id': 'ImmunBioProBrachy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary brachytherapy', 'description': 'Patients receiving sole primary brachytherapy (either LDR-BT or HDR-BT) for low or low intermediate risk prostate cancer'}, {'label': 'Salvage brachytherapy', 'description': 'Patients receiving sole brachytherapy (either PDR-BT or HDR-BT) for locally recurrent prostate cancer after prior irradiation with prostate in situ'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klinik für Strahlentherapie Augsburg', 'role': 'CONTACT', 'email': 'strahlenklinik@uk-augsburg.de', 'phone': '+49 821 400-2080'}], 'facility': 'Klinik für Strahlentherapie', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Strahlenklinik Erlangen Ambulanz', 'role': 'CONTACT', 'email': 'sekretariat.strahlenklinik@uk-erlangen.de', 'phone': '+4991318534080'}], 'facility': 'Strahlenklinik Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klinik und Poliklinik für Strahlentherapie und Radioonkologie', 'role': 'CONTACT', 'email': 'strahl.onlinetermine@med.uni-muenchen.de', 'phone': '+49 (0)89 / 4400 - 73770'}], 'facility': 'Klinik und Poliklinik für Strahlentherapie und Radioonkologie', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Claudia Schweizer, MD', 'role': 'CONTACT', 'email': 'claudia.schweizer@uk-erlangen.de', 'phone': '+49 9131 85 33968'}, {'name': 'Anna-Jasmina Donaubauer, Dr. rer. nat.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Claudia Schweizer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Strahlenklinik Universitätsklinikum Erlangen'}, {'name': 'Anna-Jasmina Donaubauer, Dr. rer. nat.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Strahlenklinik Universitätsklinikum Erlangen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bavarian Cancer Research Center (BZKF)', 'class': 'UNKNOWN'}, {'name': 'University Hospital Augsburg', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Claudia Schweizer MD', 'investigatorFullName': 'Claudia Schweizer', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}