Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT03982706
Status:
UNKNOWN
Last Update Posted:
2019-06-13
First Post:
2018-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-06-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy)', 'timeFrame': '5 years', 'description': 'PSA will be taken every 3 months during the first year after procedure, and every 6 months in the next following 4 years'}, {'measure': 'Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy.', 'timeFrame': '5 years', 'description': 'clinically significant prostate cancer is defined as Gleason 7 and above'}], 'secondaryOutcomes': [{'measure': 'Change in urinary symptoms measured by International Prostate Symptom Score (IPSS) questioner', 'timeFrame': '5 years', 'description': 'IPSS questioner is a validated tool to assess urinary symptoms. Total score is ranged 0-35. Lower values represent a better outcome.\n\nIPSS will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure'}, {'measure': 'Change in erectile function measured by International Index of Erectile Function (IIEF-5) questioner', 'timeFrame': '5 years', 'description': 'IIEF-5 questioner is a validated tool to assess erectile function in men. Total score is ranged 1-25. Higher values represent a better outcome.\n\nIIEF-5 will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI-targeted prostate biopsy', 'focal treatment'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '24399786', 'type': 'BACKGROUND', 'citation': 'Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.'}, {'pmid': '12117612', 'type': 'BACKGROUND', 'citation': 'Kaplan I, Oldenburg NE, Meskell P, Blake M, Church P, Holupka EJ. Real time MRI-ultrasound image guided stereotactic prostate biopsy. Magn Reson Imaging. 2002 Apr;20(3):295-9. doi: 10.1016/s0730-725x(02)00490-3.'}, {'pmid': '15288239', 'type': 'BACKGROUND', 'citation': 'Brown SB, Brown EA, Walker I. The present and future role of photodynamic therapy in cancer treatment. Lancet Oncol. 2004 Aug;5(8):497-508. doi: 10.1016/S1470-2045(04)01529-3.'}, {'pmid': '19917860', 'type': 'RESULT', 'citation': 'Klotz L, Zhang L, Lam A, Nam R, Mamedov A, Loblaw A. Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol. 2010 Jan 1;28(1):126-31. doi: 10.1200/JCO.2009.24.2180. Epub 2009 Nov 16.'}, {'pmid': '12137824', 'type': 'RESULT', 'citation': 'Wise AM, Stamey TA, McNeal JE, Clayton JL. Morphologic and clinical significance of multifocal prostate cancers in radical prostatectomy specimens. Urology. 2002 Aug;60(2):264-9. doi: 10.1016/s0090-4295(02)01728-4.'}, {'pmid': '21849184', 'type': 'RESULT', 'citation': 'Pinto PA, Chung PH, Rastinehad AR, Baccala AA Jr, Kruecker J, Benjamin CJ, Xu S, Yan P, Kadoury S, Chua C, Locklin JK, Turkbey B, Shih JH, Gates SP, Buckner C, Bratslavsky G, Linehan WM, Glossop ND, Choyke PL, Wood BJ. Magnetic resonance imaging/ultrasound fusion guided prostate biopsy improves cancer detection following transrectal ultrasound biopsy and correlates with multiparametric magnetic resonance imaging. J Urol. 2011 Oct;186(4):1281-5. doi: 10.1016/j.juro.2011.05.078. Epub 2011 Aug 17.'}, {'pmid': '23158413', 'type': 'RESULT', 'citation': 'Sonn GA, Natarajan S, Margolis DJ, MacAiran M, Lieu P, Huang J, Dorey FJ, Marks LS. Targeted biopsy in the detection of prostate cancer using an office based magnetic resonance ultrasound fusion device. J Urol. 2013 Jan;189(1):86-91. doi: 10.1016/j.juro.2012.08.095. Epub 2012 Nov 14.'}, {'pmid': '24722183', 'type': 'RESULT', 'citation': 'Shaw GL, Thomas BC, Dawson SN, Srivastava G, Vowler SL, Gnanapragasam VJ, Shah NC, Warren AY, Neal DE. Identification of pathologically insignificant prostate cancer is not accurate in unscreened men. Br J Cancer. 2014 May 13;110(10):2405-11. doi: 10.1038/bjc.2014.192. Epub 2014 Apr 10.'}, {'pmid': '22818143', 'type': 'RESULT', 'citation': 'Barzell WE, Melamed MR, Cathcart P, Moore CM, Ahmed HU, Emberton M. Identifying candidates for active surveillance: an evaluation of the repeat biopsy strategy for men with favorable risk prostate cancer. J Urol. 2012 Sep;188(3):762-7. doi: 10.1016/j.juro.2012.04.107. Epub 2012 Jul 19.'}, {'pmid': '24262102', 'type': 'RESULT', 'citation': 'Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8.'}, {'pmid': '23063807', 'type': 'RESULT', 'citation': 'Kasivisvanathan V, Dufour R, Moore CM, Ahmed HU, Abd-Alazeez M, Charman SC, Freeman A, Allen C, Kirkham A, van der Meulen J, Emberton M. Transperineal magnetic resonance image targeted prostate biopsy versus transperineal template prostate biopsy in the detection of clinically significant prostate cancer. J Urol. 2013 Mar;189(3):860-6. doi: 10.1016/j.juro.2012.10.009. Epub 2012 Oct 11.'}, {'pmid': '17997026', 'type': 'RESULT', 'citation': 'Blana A, Murat FJ, Walter B, Thuroff S, Wieland WF, Chaussy C, Gelet A. First analysis of the long-term results with transrectal HIFU in patients with localised prostate cancer. Eur Urol. 2008 Jun;53(6):1194-201. doi: 10.1016/j.eururo.2007.10.062. Epub 2007 Nov 5.'}, {'pmid': '25485722', 'type': 'RESULT', 'citation': "Mearini L, D'Urso L, Collura D, Nunzi E, Muto G, Porena M. High-intensity focused ultrasound for the treatment of prostate cancer: A prospective trial with long-term follow-up. Scand J Urol. 2015;49(4):267-74. doi: 10.3109/21681805.2014.988174. Epub 2014 Dec 8."}, {'pmid': '27697580', 'type': 'RESULT', 'citation': 'Valerio M, Dickinson L, Ali A, Ramachadran N, Donaldson I, Mccartan N, Freeman A, Ahmed HU, Emberton M. Nanoknife Electroporation Ablation Trial: A Prospective Development Study Investigating Focal Irreversible Electroporation for Localized Prostate Cancer. J Urol. 2017 Mar;197(3 Pt 1):647-654. doi: 10.1016/j.juro.2016.09.091. Epub 2016 Sep 30.'}, {'pmid': '25072507', 'type': 'RESULT', 'citation': 'Valerio M, Dickinson L, Ali A, Ramachandran N, Donaldson I, Freeman A, Ahmed HU, Emberton M. A prospective development study investigating focal irreversible electroporation in men with localised prostate cancer: Nanoknife Electroporation Ablation Trial (NEAT). Contemp Clin Trials. 2014 Sep;39(1):57-65. doi: 10.1016/j.cct.2014.07.006. Epub 2014 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.', 'detailedDescription': 'Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data.\n\nThe following information will be collected for all patients:\n\n* Demographic data: date of birth, age, gender, ethnicity, Height, weight.\n* Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests.\n\nFor patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected:\n\n* MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values.\n* Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable).\n\nFor patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected:\n\n* Procedure details.\n* Evaluation of success: results of following PSA test, MRI and/or prostate biopsy.\n\nPatients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men, age 18-90, which have underwent, or are scheduled to undergo, MRI-US FUSION, HIFU, NanoKnife or Cryotherapy at the Ramat Aviv Medical Center or Rabin Medical Center', 'genderDescription': 'participant eligibility is based on gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center\n2. Age 18-90.\n\nExclusion Criteria:\n\nNone.'}, 'identificationModule': {'nctId': 'NCT03982706', 'briefTitle': 'Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy', 'orgStudyIdInfo': {'id': '0316-16-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MRI-US Fusion', 'description': 'patients undergoing MRI targeted prostate biopsy'}, {'label': 'Focal', 'description': 'patients undergoing focal treatment for localized prostate cancer (HIFU, NanoKnife, Cryotherapy)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Margel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}