Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02739659
Status:
UNKNOWN
Last Update Posted:
2021-11-19
First Post:
2016-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbon Ion Radiotherapy for the Treatment of Localized 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'From the date of CIRT to 6 months after the completion of CIRT, up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival of all patients', 'timeFrame': 'From the diagnosis of localized prostate, a median of 2 years'}, {'measure': 'biochemical failure-free survival，bFFS', 'timeFrame': 'From the completion of CIRT, a median of 2 years'}, {'measure': 'Progression-free survival of all patients', 'timeFrame': 'From the completion of CIRT, a median of 2 years'}]}, 'conditionsModule': {'keywords': ['prostate carcinoma', 'carbon-ion radiotherapy', 'efficacy', 'toxicity'], 'conditions': ['Prostate Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31164172', 'type': 'DERIVED', 'citation': 'Zhang Y, Li P, Yu Q, Wu S, Chen X, Zhang Q, Fu S. Preliminary exploration of clinical factors affecting acute toxicity and quality of life after carbon ion therapy for prostate cancer. Radiat Oncol. 2019 Jun 4;14(1):94. doi: 10.1186/s13014-019-1303-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer', 'detailedDescription': 'The purpose of this study is to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 6 months after the completion of CIRT. Once the MTD for localized prostate cancer is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed adenocarcinoma of the prostate\n* No lymph node and distant metastasis\n* Age ≥ 20 and \\< 85 years of age\n* Karnofsky Performance Score ≥70\n* No previous pelvic radiation therapy (RT)\n* No previous prostatectomy\n* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer\n* Ability to understand character and individual consequences of the clinical trial\n* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial\n\nExclusion Criteria:\n\n* No pathologically confirmed adenocarcinoma of the prostate\n* Pelvic lymph node metastasis (N1)\n* Distant metastasis (M1)\n* Urinary obstructive symptoms (IPSS \\> 20)\n* Previous pelvic radiotherapy\n* Previous prostatectomy\n* Severe systemic disorders\n* Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)\n* Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer\n* Non conformity of the radiotherapy dose distribution when compared to the dose constraints\n* Psychiatric disorders or any other condition that can make unreliable the informed consent'}, 'identificationModule': {'nctId': 'NCT02739659', 'briefTitle': 'Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Proton and Heavy Ion Center'}, 'orgStudyIdInfo': {'id': 'SPHIC-TR-PCa 2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'carbon-ion radiotherapy', 'description': 'Five dose levels \\[59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0 GyE/16Fx and 65.6 GyE/16Fx\\] are planned within the Phase I part. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65.6 GyE/16Fx are safely delivered, the recommended dose (or 65.6 GyE/16Fx) will be the prescribed dose in the Phase II part of the study.', 'interventionNames': ['Device: carbon-ion radiotherapy']}], 'interventions': [{'name': 'carbon-ion radiotherapy', 'type': 'DEVICE', 'armGroupLabels': ['carbon-ion radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201321', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Li, Dr.', 'role': 'CONTACT', 'email': 'ping.li@sphic.org.cn'}, {'name': 'Qing Zhang, Dr.', 'role': 'CONTACT', 'email': 'qing.zhang@sphic.org.cn'}, {'name': 'Qing Zhang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Proton and Heavy Ion Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ping Li, Dr.', 'role': 'CONTACT', 'email': 'ping.li@sphic.org.cn'}], 'overallOfficials': [{'name': 'Qing Zhang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Proton and Heavy Ion Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Proton and Heavy Ion Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DIRECTOR', 'investigatorFullName': 'Qing Zhang,MD', 'investigatorAffiliation': 'Shanghai Proton and Heavy Ion Center'}}}}