Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT03225235
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2017-05-19', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'QoL-EORTC quality of life', 'timeFrame': '5 years', 'description': 'For QoL the EORTC questionnaire (C30 with PR25) is used.'}], 'primaryOutcomes': [{'measure': 'survival time without biochemical recurrence,', 'timeFrame': '5 years', 'description': 'Phoenix definition of biochemical failure'}], 'secondaryOutcomes': [{'measure': 'survival time specific for prostate cancer,', 'timeFrame': '5 years', 'description': 'the period of time from randomization until death from prostate cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer, SBRT, Ultrafractionation, CyberKnife'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.', 'detailedDescription': 'Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed \\<180 days prior to the randomization date,\n* completed assessment of tumor differentiation according to Gleason grading allows to perform stratification;\n* general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1),\n* belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2),\n* PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation,\n* no distant metastases,\n* signing informed consent,\n* morphological and biochemical blood parameters within the normal limits.\n\nExclusion Criteria:\n\n* the presence of active cancer, except skin cancer preceding period 5 years prior to randomization,\n* surgical treatment (radical prostatectomy) or RT in the pelvic area,\n* co-morbidities that may significantly affect the expectancy life of the patients\n* do not meet the criteria for inclusion.'}, 'identificationModule': {'nctId': 'NCT03225235', 'acronym': 'CYBERPROST', 'briefTitle': 'Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Greater Poland Cancer Centre'}, 'officialTitle': 'Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.', 'orgStudyIdInfo': {'id': 'CYBERPROST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated Stereotactic SBRT', 'description': 'By assuming a hypofractionated irradiation scheme, it is assumed that between the fractions sublethal radiation damage is being treated and the time factor does not significantly affect RT result. The SBRT fractional dose was determined on the basis of a Biologically Effective Dose (BED) calculation using a linear-square model, which assumes that α / β takes the following values for:\n\n* tumor (RS) = 1.5\n* Late rectal and bladder complications = 3.0\n* early rectal and bladder complications = 10.0.', 'interventionNames': ['Radiation: SBRT']}], 'interventions': [{'name': 'SBRT', 'type': 'RADIATION', 'description': 'hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer', 'armGroupLabels': ['Hypofractionated Stereotactic SBRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-866', 'city': 'Poznan', 'state': 'Wielkopolska', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Piotr Milecki, MD PhD', 'role': 'CONTACT', 'email': 'piotr.milecki@wco.pl', 'phone': '+48 61 885 08 78'}, {'name': 'Sylwia Krąkowska, MA', 'role': 'CONTACT', 'email': 'sylwia.krakowska@wco.pl', 'phone': '+48 61 885 08 78'}, {'name': 'Piotr Milecki, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Greater Poland Cancer Centre', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Piotr Milecki, PhD., MD', 'role': 'CONTACT', 'email': 'piotr.milecki@wco.pl', 'phone': '+48618850878'}, {'name': 'Sylwia Krąkowska, MD', 'role': 'CONTACT', 'email': 'sylwia.krakowska@wco.pl', 'phone': '+48 61 885 08 78'}], 'overallOfficials': [{'name': 'Piotr Milecki, PhD., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Greater Poland Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Greater Poland Cancer Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}