Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT03322020
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute toxicity assessment for 18 Gy and 21 Gy arm', 'timeFrame': '3 months', 'description': 'CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)'}], 'secondaryOutcomes': [{'measure': 'Biochemical control free survival', 'timeFrame': '3 years', 'description': 'PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy'}, {'measure': 'Late toxicity assessment for 18 Gy and 21 Gy arm', 'timeFrame': 'average 6 months', 'description': 'Late Effects of Normal Tissues (LENT) scoring system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasm, Prostate']}, 'referencesModule': {'references': [{'pmid': '33032643', 'type': 'DERIVED', 'citation': 'Kim YJ, Ahn H, Kim CS, Kim YS. Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR). Radiat Oncol. 2020 Oct 8;15(1):234. doi: 10.1186/s13014-020-01665-6.'}, {'pmid': '29609646', 'type': 'DERIVED', 'citation': 'Kim YJ, Ahn H, Kim CS, Lee JL, Kim YS. Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate- or high-risk prostate cancer: a study protocol for a randomized controlled, pilot trial. Trials. 2018 Apr 2;19(1):212. doi: 10.1186/s13063-018-2574-y.'}]}, 'descriptionModule': {'briefSummary': 'For the treatment for intermediate- and high-risk prostate cancer, Cyberknife boost will be used after 4 weeks of intensity modulated radiotherapy to pelvis. The boost doses are 18 Gy and 21 Gy in 3 fractions, respectively. The investigators plan to evaluate the toxicity of two dose groups and decide the appropriate dose for Cyberknife boost. Also, PSA control will be evaluated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment\n* ECOG performance status 0-1\n* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl\n* Appropriate values of kidney function within 6 months after enrollment Creatinine \\< 2.0 ng/dL\n* Appropriate values of liver function within 6 months after enrollment total bilirubin \\< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \\< 2.5 X maximum normal value\n\nExclusion Criteria:\n\n* Presence of distant metastasis\n* Presence of pelvic LN metastasis\n* History of androgen deprivation therapy within 6 months after enrollment\n* History of definitive treatment for prostate cancer (e.g., radical prostatectomy)\n* History of pelvic irradiation\n* Double primary cancer other than skin/thyroid cancer'}, 'identificationModule': {'nctId': 'NCT03322020', 'acronym': 'ADEBAR', 'briefTitle': 'Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'S2016-0351-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CK 18 Gy', 'description': 'Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions', 'interventionNames': ['Radiation: Cyberknife boost 18 Gy']}, {'type': 'EXPERIMENTAL', 'label': 'CK 21 Gy', 'description': 'Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions', 'interventionNames': ['Radiation: Cyberknife boost 21 Gy']}], 'interventions': [{'name': 'Cyberknife boost 18 Gy', 'type': 'RADIATION', 'description': 'pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx', 'armGroupLabels': ['CK 18 Gy']}, {'name': 'Cyberknife boost 21 Gy', 'type': 'RADIATION', 'description': 'pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx', 'armGroupLabels': ['CK 21 Gy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Seok Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Young Seok Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}