Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-29 @ 10:29 AM
Study NCT ID:
NCT06665932
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], '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': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute toxicity incidence', 'timeFrame': '3 months from treatment', 'description': 'Incidence of acute urological toxicity grade 2 and more according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.03 scale'}, {'measure': 'Acute toxicity of the lower gastrointestinal tract (GIT)', 'timeFrame': '3 months from treatment', 'description': 'Incidence of acute toxicity of the lower GIT grade 2 and more according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.03 scale'}], 'secondaryOutcomes': [{'measure': '5-year cumulative toxicity', 'timeFrame': '5 years', 'description': '5-year cumulative toxicity (urological and lower GIT) according to the CTCAE 4.03 scale'}, {'measure': 'Quality of Life according to the EPIC-26 scale', 'timeFrame': '5 years from treatment', 'description': 'Quality of Life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26) scale'}, {'measure': 'Quality of life (EQ-5D)', 'timeFrame': '5 years from treatment', 'description': 'Quality of Life will be assessed using the EQ-5D tool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'Stereotactic Body Radiotherapy', 'acute toxicity', 'late toxicity'], 'conditions': ['Prostate Cancer (Adenocarcinoma)']}, 'referencesModule': {'references': [{'pmid': '36633877', 'type': 'BACKGROUND', 'citation': 'Kishan AU, Ma TM, Lamb JM, Casado M, Wilhalme H, Low DA, Sheng K, Sharma S, Nickols NG, Pham J, Yang Y, Gao Y, Neylon J, Basehart V, Cao M, Steinberg ML. Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. JAMA Oncol. 2023 Mar 1;9(3):365-373. doi: 10.1001/jamaoncol.2022.6558.'}, {'pmid': '17482880', 'type': 'BACKGROUND', 'citation': 'Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to reduce the PTV (Planning Target Volume) safety margins to 1-2 mm in stereotactic prostate radiotherapy for low- and medium-risk prostate cancers while maintaining a dose of 36.25 Gy in 5 fractions per day. By reducing the hems, the investigators expect a reduction of acute and late toxicity on the organs at risk, dominantly the urethra, bladder, penile bulb, and rectum, and an improvement in the quality of life.', 'detailedDescription': 'In this prospective study, a total of 100 patients will be treated over 2 years. Patients will be implanted with 4 contrast markers (fiducials) in the prostate - in the base, apex, and right and left lobes of the prostate. Subsequently, 3 planning examinations will be performed: 1. CT with a urinary catheter immediately after the implantation of fiducials (gold contrast markers), with a distance from implantation 2. planning CT and MR without a urinary catheter. The CTV (Clinical Target Volume) will be defined by the prostate, and the border on the PTV will be reduced from 3-5 mm to 1-2 mm isometrically to maximize the reduction of doses to the organs at risk (rectum, bladder, and urethra, penile bulb, testes), the organs at risk (OAR) will be marked in the radiation plan as OAR. Subsequently, the patients will be irradiated with a dose of 36.25 Gy in 5 fractions per day. Acute toxicity will be evaluated in the 1st and 3rd month after radiotherapy, and late toxicity after 4-6 months according to CTCAE criteria (Common Terminology Criteria for Adverse Events).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only male patients with prostate cancer will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically verified, localized prostate cancer without regional lymphadenopathy or distant metastases\n* low or intermediate risk - favorable risk\n* staging according to NCCN recommendations:\n* low risk: no staging required\n* intermediate risk- favorable risk: CT abdomen and pelvis\n* PSA up to 15\n* age over 18 years\n* signed informed consent form\n* suitable position of fiducials (to be determined by the physicist)\n\nExclusion Criteria:\n\n* a histological type other than acinar adenocarcinoma\n* the presence of local lymphadenopathy or distant metastases\n* a dominant lesion in the periphery that is in contact with the capsule or grows through it\n* PSA over 15\n* unsatisfactory position of fiducials (to be determined by the physicist)\n* previous treatment with radiotherapy to the pelvic area'}, 'identificationModule': {'nctId': 'NCT06665932', 'briefTitle': 'Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins', 'orgStudyIdInfo': {'id': 'ONK-11-SBRT'}, 'secondaryIdInfos': [{'id': '16/RVO-FNOs/2024', 'type': 'OTHER_GRANT', 'domain': 'University Hospital Ostrava'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Men with prostate cancer', 'interventionNames': ['Procedure: Stereotactic radiotherapy']}], 'interventions': [{'name': 'Stereotactic radiotherapy', 'type': 'PROCEDURE', 'description': 'Stereotactic surgery is a minimally invasive form of surgical intervention that makes use of a three-dimensional coordinate system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery, etc.', 'armGroupLabels': ['Men with prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '708 52', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}, {'name': 'Zuzana Zděblová-Čermáková, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tomáš Blažek, MD, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lukáš Knybel, Ing., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pavla Benýšková, Mgr., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zuzana Růžičková, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pavla Hanzlíková, MD, Ph.D., MBA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'centralContacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is no plan to make individual participant data available to other researchers. The data may be provided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}