Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-04-22 @ 3:13 PM
Study NCT ID:
NCT03235557
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CyberKnife for Prostate Cancer Patients Aged 70 y or More
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-20', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute and late toxicity (Using the CTCAEv4)', 'timeFrame': 'During 36 months after treatment', 'description': 'Using the CTCAEv4'}], 'secondaryOutcomes': [{'measure': 'PSA evaluation', 'timeFrame': 'at 4 and 6 months, than every 6 months for 3 years', 'description': 'PSA Dosage'}, {'measure': 'Digital rectal exam', 'timeFrame': 'at 6, 12, 24 and 36 months', 'description': 'Clinical examination (digital rectal exam)'}, {'measure': 'Birads score evaluation', 'timeFrame': 'at 36 months', 'description': 'Multiparametric prostatic MRI'}, {'measure': 'IPSS evaluation', 'timeFrame': 'at 12, 24 and 36 months', 'description': 'IPSS score'}, {'measure': 'IIEF5 evaluation', 'timeFrame': 'at 12, 24 and 36 months', 'description': 'IIEF5 score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate', 'cancer', 'radiation', 'stereotactic', 'CyberKnife', 'elderly'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '20724012', 'type': 'RESULT', 'citation': 'Nickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which alpha/beta ratio and half-time of repair are useful for predicting outcomes in prostate cancer? Radiother Oncol. 2010 Dec;97(3):462-6. doi: 10.1016/j.radonc.2010.06.006. Epub 2010 Aug 17.'}, {'pmid': '21464418', 'type': 'RESULT', 'citation': 'Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4.'}, {'pmid': '21300474', 'type': 'RESULT', 'citation': 'King CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.\n\nInclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) \\<30ng/ml.\n\nDose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores\\>5.\n\nPrimary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.', 'detailedDescription': 'Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.\n\nRationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now curative treatments were not proven to increase overall survival rates. Therefore, very short, comfortable and safe treatments have to be designed to increase the pelvic control of the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using hypofractionation schemes.\n\nPrimary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response and quality of life evaluation.\n\nInclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA\\<30ng/ml.\n\nDose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5 fractions, in 10 days, considering CAPRA Scores\\>5.\n\nDoses to the Organs At Risk (OAR) : Rectum wall : V36.25\\<2%, V27\\<20%, V23\\<30%, V20\\<35%. Bladder wall : V36.25\\<2%, V27\\<20%, V20\\<35%. Considering specifically the prescription of 37.5 Gray, the rectum and bladder wall: V37.5\\<2%. Anytime, hot spots of 105 % of the prescription dose must avoid the urethra.\n\nEvaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA, multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International Index of Erectile Function).\n\nMethodolgy : this is a three step prospective, observational study of 20 patients each step. Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1 year must remain below 5% each.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients suffering prostatic adenocarcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T1-T3b,\n* MRI pelvic nodes negative,\n* M0,\n* any Gleason Score,\n* PSA\\<30ng/ml,\n* WHO (World Health Organisation) score\\<2, IPSS≤15,\n* maximal urinary flow rate ≥15ml/s,\n* mean urinary flow rate ≥5ml/s,\n* multiparametric prostatic and pelvis MRI\n\nExclusion Criteria:\n\n* Prostatic volume \\> 100cc,\n* TURP (transurethral prostatectomy) \\<3 y,\n* any recurrent prostatitis within the last 3 years,\n* collagenose diseases,\n* ulcero-haemorrhagic rectocolitis or\n* crohn diseases'}, 'identificationModule': {'nctId': 'NCT03235557', 'acronym': 'ProRobot', 'briefTitle': 'CyberKnife for Prostate Cancer Patients Aged 70 y or More', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse, Luxembourg'}, 'officialTitle': 'Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More', 'orgStudyIdInfo': {'id': 'CYM Prostate CFB 1'}}, 'contactsLocationsModule': {'locations': [{'zip': '4005', 'city': 'Esch-sur-Alzette', 'country': 'Luxembourg', 'facility': 'Centre Francois Baclesse', 'geoPoint': {'lat': 49.49583, 'lon': 5.98056}}], 'overallOfficials': [{'name': 'Philippe Nickers, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Francois Baclesse'}, {'name': 'Michel Untereiner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Francois Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse, Luxembourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}