Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT03920033
Status:
RECRUITING
Last Update Posted:
2021-01-20
First Post:
2019-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], '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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical recurrence-free survival', 'timeFrame': '5 years', 'description': 'PSA \\>0.2 ng/mLfollowed by a repeat measurement \\>0.2 ng/mL'}], 'secondaryOutcomes': [{'measure': 'Acute toxicities', 'timeFrame': 'Adverse effects occured during radiation therapy, and within 3 months after radiation therapy', 'description': 'Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0'}, {'measure': 'Chronic toxicities', 'timeFrame': 'Adverse effects occured after 3 months since end of radiation therapy', 'description': 'Evaulation using CTCAE 4.0'}, {'measure': 'Quality of life 1', 'timeFrame': 'the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years', 'description': 'Expanded prostate cancer index composite (EPIC) Questionnaire Korean version EPIC consists of 50 questions in total divided into four domains: bowel (14 questions), urinary (12 questions), sexual (13 questions), and hormonal aspects (13 questions).\n\nScores of each domain will be separately reported. Response options for each EPIC item form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale.\n\nThe higher the score, the higher the quality of life.'}, {'measure': 'Quality of life 2', 'timeFrame': 'the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years', 'description': 'European Organization for Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) Korean version EORTC QLQ-C30 consists of 30 questions, and total score will be reported. Response options for each EPIC question form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale.\n\nThe higher the score, the higher the quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Biochemical Recurrence', 'Radiation', 'Hypofractionation', 'Dose Escalation', 'Survival', 'Radiation Toxicity', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '34674739', 'type': 'DERIVED', 'citation': 'Park G, Kim YJ, Ahn H, Park W, Lee JS, Kim YS. Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial. Trials. 2021 Oct 21;22(1):728. doi: 10.1186/s13063-021-05708-5.'}]}, 'descriptionModule': {'briefSummary': 'Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.\n\nIt is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.'}, '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\n* Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \\<=1.0 ng/mL)\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* Clinically gross recurrent tumor\n* Presence of distant metastasis\n* Presence of pelvic LN metastasis\n* History of pelvic irradiation\n* History of cryotherapy or brachytherapy for prostate cancer\n* Double primary cancer other than skin/thyroid cancer\n* Combined serious morbidity'}, 'identificationModule': {'nctId': 'NCT03920033', 'acronym': 'SHARE', 'briefTitle': 'Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study', 'orgStudyIdInfo': {'id': 'S2019-0154-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated', 'description': '65 Gy/ 26 fractions (fraction size 2.5 Gy)', 'interventionNames': ['Radiation: Salvage radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': '66 Gy/ 33 fractions (fraction size 2 Gy)', 'interventionNames': ['Radiation: Salvage radiation therapy']}], 'interventions': [{'name': 'Salvage radiation therapy', 'type': 'RADIATION', 'description': 'Salvage radiation therapy for biochemical recurrence', 'armGroupLabels': ['Hypofractionated', 'Standard']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Seok Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ysk@amc.seoul.kr', 'phone': '82 2 3010 5614', 'phoneExt': '5614'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won Park, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'wonp68@skku.edu', 'phone': '82-2-3410-2616'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Young Seok Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ysk@amc.seoul.kr', 'phone': '82 2 3010 5614', 'phoneExt': '5614'}, {'name': 'Yeon Joo Kim, M.D.', 'role': 'CONTACT', 'email': 'kamea1004@naver.com', 'phone': '82 2 258 9243', 'phoneExt': '9243'}], 'overallOfficials': [{'name': 'Young Seok Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young Seok Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}