Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 2:15 AM
Study NCT ID:
NCT03424850
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-01-31', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Optimal dose of radiation', 'timeFrame': 'Through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)', 'description': '-The optimal dose is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity within the DLT assessment period (3 months after implant) OR the maximally administered dose if fewer than 2 patients in that cohort experience DLT.'}], 'primaryOutcomes': [{'measure': 'Biochemical control experienced by patients with prostate cancer treated with an HDR implant', 'timeFrame': 'Through 3 years after implant', 'description': '-Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir'}], 'secondaryOutcomes': [{'measure': 'Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant', 'timeFrame': 'From start of treatment through 90 days', 'description': '-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.'}, {'measure': 'Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant', 'timeFrame': 'From day 91 through 3 years after implant', 'description': '-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of early stage prostate cancer.\n* Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA \\< 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores \\< 50%, no more than one NCCN intermediate risk factor).\n* Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.\n* A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.\n* Currently receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Unable to undergo general, spinal or local anesthesia.\n* Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment."}, 'identificationModule': {'nctId': 'NCT03424850', 'briefTitle': 'Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy', 'orgStudyIdInfo': {'id': '201801118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HDR brachytherapy - 21 Gy', 'description': '-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy.', 'interventionNames': ['Radiation: HDR brachytherapy']}, {'type': 'EXPERIMENTAL', 'label': 'HDR brachytherapy - 23 Gy', 'description': '-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.', 'interventionNames': ['Radiation: HDR brachytherapy']}, {'type': 'EXPERIMENTAL', 'label': 'HDR brachytherapy - 25 Gy', 'description': '-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy.', 'interventionNames': ['Radiation: HDR brachytherapy']}], 'interventions': [{'name': 'HDR brachytherapy', 'type': 'RADIATION', 'description': '* Dose constraints for 21 Gy:\n\n * Bladder and rectum: V70 \\< 1 cc\n * Urethra: V115 \\< 1 cc\n * V135: 0%\n* Dose constraints for 23 Gy:\n\n * Bladder and rectum: V65 \\< 1 cc\n * Urethra: V105 \\< 1 cc\n * V125: 0%\n* Dose constraints for 25 Gy:\n\n * Prostate V100 \\>90% (\\>95% preferred)\n * Bladder and rectum: V70 \\< 1 cc, Dmax \\<115%\n * Urethra: V110 \\< 1 cc, Dmax \\<120%', 'armGroupLabels': ['HDR brachytherapy - 21 Gy', 'HDR brachytherapy - 23 Gy', 'HDR brachytherapy - 25 Gy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hiram A Gay, M.D.', 'role': 'CONTACT', 'email': 'hiramgay@wustl.edu', 'phone': '314-362-8516'}, {'name': 'Hiram A Gay, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeff M Michalski, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joshua Schiff, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Trevor Zimmerman', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Altman, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Hiram A Gay, M.D.', 'role': 'CONTACT', 'email': 'hiramgay@wustl.edu', 'phone': '314-362-8516'}], 'overallOfficials': [{'name': 'Hiram A Gay, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}