Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT02600156
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2015-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2015-09-04', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '3 years', 'description': 'To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.'}, {'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': '3 years', 'description': 'To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.'}], 'secondaryOutcomes': [{'measure': 'Short- and mid-term ablative success', 'timeFrame': '3 years', 'description': 'To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Adenocarcinoma', 'Stage I Prostate Cancer AJCC v8', 'Stage II Prostate Cancer AJCC v8', 'Localized Prostate Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.', 'detailedDescription': 'The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male, 45 years of age or older.\n* Diagnosis of prostate adenocarcinoma.\n* Clinical stage T1c or T2a.\n* Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6\n* PSA less than or equal to 20 ng/mL\n* Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.\n* No lesion \\> or = 2cm\n* One, two, or three tumor suspicious regions identified on multiparametric MRI\n* No definite radiographic indication of extra-capsular extension.\n* Estimated survival of 5 years or greater, as determined by treating physician.\n* Tolerance for anesthesia/sedation.\n* Ability to give informed consent.\n\nExclusion Criteria\n\n* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.\n* History of other primary non-skin malignancy within previous three years.'}, 'identificationModule': {'nctId': 'NCT02600156', 'briefTitle': 'Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors', 'orgStudyIdInfo': {'id': '14-005500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm study', 'description': 'MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.', 'interventionNames': ['Procedure: Focal laser ablation of the prostate']}], 'interventions': [{'name': 'Focal laser ablation of the prostate', 'type': 'PROCEDURE', 'otherNames': ['Visualase Laser Ablation'], 'description': 'MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.', 'armGroupLabels': ['Single arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'David Woodrum, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'David A. Woodrum, M.D., Ph.D.', 'investigatorFullName': 'David A. Woodrum', 'investigatorAffiliation': 'Mayo Clinic'}}}}