Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-02-28 @ 5:33 AM
Study NCT ID:
NCT02181192
Status:
UNKNOWN
Last Update Posted:
2016-08-01
First Post:
2014-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival according to PSA-value', 'timeFrame': 'at the end of follow-up period of 4 years', 'description': 'Subjects in the control arm have an aftertreatment period of 5 years. Follow-up period of intervention arm ends after 3 to 5 years after radiotherapy. Duration depends on the surveillance period until marginal value is reached. This period is subtracted from maximum follow-up period of 5 years.'}], 'secondaryOutcomes': [{'measure': 'frequency of PSA-persistence', 'timeFrame': 'at the end of therapy , an expected average of 6 weeks'}, {'measure': 'frequency of changes in therapeutic strategies by additional diagnostics', 'timeFrame': 'at the end of therapy , an expected average of 6 weeks'}, {'measure': 'analysis for radiation parameters, restricted to patients of initiating center', 'timeFrame': 'at the end of therapy , an expected average of 6 weeks'}, {'measure': 'therapy and following costs for patients', 'timeFrame': 'time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years'}, {'measure': 'overall survival', 'timeFrame': 'at the end of therapy , an expected average of 6 weeks'}, {'measure': 'quality of life and side effects', 'timeFrame': 'time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biochemical recurrence', 'prostate carcinoma', 'prostate cancer', 'PSA', 'postoperative', 'radiotherapy', 'imaging diagnostic', 'PET/CT', 'social economic aspects', 'quality of life'], 'conditions': ['Prostate Cancer', 'Recurrence']}, 'descriptionModule': {'briefSummary': "PSA-recurrence prostate carcinoma is associated with two general problems.\n\n1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.\n2. There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value \\< 0.5 ng/ml according to german S3 guidelines is based on retrospective data.\n\nThese difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value \\>= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postoperative, biochemical recurrent prostate carcinoma with PSA value between 0.2 to 0.99 ng/ml\n* prior irradiation\n* comprehension of study protocol content and signed informed consent form\n* minimum age 18 years\n\nExclusion Criteria:\n\n* primary therapy of prostate carcinoma\n* PSA value \\>= 1 ng/ml\n* diagnosed distant metastases before randomisation (osseous or systemic)\n* performed PET/CT before randomisation\n* malignant slave tumor\n* potent men that are not willing or are unable to apply consequent contraception\n* ongoing drug- and/or alcohol abuse\n* patients that are not willing or able to cooperate according to protocol\n* patients in care\n* patients that are not able to understand German language'}, 'identificationModule': {'nctId': 'NCT02181192', 'acronym': 'PROST-I', 'briefTitle': 'Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1', 'orgStudyIdInfo': {'id': 'PROST-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'delayed radiotherapy', 'description': 'PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging', 'interventionNames': ['Device: PET/CT', 'Radiation: Radiotherapy after achievement of PSA marginal value']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'instant radiotherapy', 'description': 'Instant Radiotherapy according to guidelines', 'interventionNames': ['Radiation: Instant Radiotherapy according to guidelines']}], 'interventions': [{'name': 'PET/CT', 'type': 'DEVICE', 'description': 'PET/CT', 'armGroupLabels': ['delayed radiotherapy']}, {'name': 'Instant Radiotherapy according to guidelines', 'type': 'RADIATION', 'description': 'Instant Radiotherapy according to guidelines', 'armGroupLabels': ['instant radiotherapy']}, {'name': 'Radiotherapy after achievement of PSA marginal value', 'type': 'RADIATION', 'description': 'Radiotherapy after achievement of PSA marginal value', 'armGroupLabels': ['delayed radiotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Annedore Strnad, Dr. MHBA', 'role': 'CONTACT', 'email': 'annedore.strnad@uk.erlangen.de', 'phone': '+49(0)9131 85 33968'}, {'name': 'Eva-Maria Weiss, Dr.', 'role': 'CONTACT', 'email': 'eva-maria.weiss@uk-erlangen.de', 'phone': '+49(0)9131 85 33968'}], 'overallOfficials': [{'name': 'Annedore Strnad, Dr. MHBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Strahlenklinik, Universitätsklinikum Erlangen'}, {'name': 'Rainer Fietkau, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Strahlenklinik, Universitätsklinikum Erlangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}