Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
Study NCT ID:
NCT06817668
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-10-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Tolerability of ePUHRT With Brachytherapy Boost
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': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with acute grade ≥ 2 GU toxicity', 'timeFrame': '3 months', 'description': 'Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5.'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with acute grade ≥ 2 GI toxicity', 'timeFrame': '3 months', 'description': 'Acute grade ≥ 2 GI toxicity at 3 months post ePUHRT with HDR boost by CTCAE version 5'}, {'measure': 'Percentage of participants with acute grade ≥ 2 GU toxicity', 'timeFrame': '3 months', 'description': 'Self-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by PRO-CTCAE'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Brachytherapy boost'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).', 'detailedDescription': 'Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Capable of providing informed consent and HIPAA authorization\n3. Karnofsky performance score ≥ 70\n4. Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician\n5. Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure\n\nExclusion Criteria:\n\n1. Prior pelvic irradiation treatment\n2. Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.\n3. Evidence of nodal or distant disease on screening diagnostic work up.\n4. Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure\n5. International Prostate Symptom Score (IPSS) score \\> 16 despite medical therapy'}, 'identificationModule': {'nctId': 'NCT06817668', 'briefTitle': 'Evaluating Tolerability of ePUHRT With Brachytherapy Boost', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'CTO-IUSCCC-0832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ePURT 5Gy x 5 fractions with single HDR boost of 15Gy', 'description': 'Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.', 'interventionNames': ['Radiation: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy']}], 'interventions': [{'name': 'ePURT 5Gy x 5 fractions with single HDR boost of 15Gy', 'type': 'RADIATION', 'description': 'ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.', 'armGroupLabels': ['ePURT 5Gy x 5 fractions with single HDR boost of 15Gy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathy Lauer', 'role': 'CONTACT', 'email': 'klauer@iuhealth.org', 'phone': '317-962-3172'}], 'facility': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Omar Ishaq, MD', 'role': 'CONTACT', 'email': 'oishaq@iuhealth.org', 'phone': '317-944-2524'}, {'name': 'Kathy Lauer, BA', 'role': 'CONTACT', 'email': 'KLauer@iuhealth.org', 'phone': '317-962-3172'}], 'overallOfficials': [{'name': 'Omar Ishaq, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University Simon Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Urology', 'investigatorFullName': 'Omar Ishaq', 'investigatorAffiliation': 'Indiana University'}}}}