Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02077335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2014-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2014-02-23', 'studyFirstSubmitQcDate': '2014-03-03', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Gastro-Intestinal (GI) Toxicity', 'timeFrame': '6 weeks, 2 years and 5 years post treatment', 'description': 'Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.'}], 'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.'}], 'secondaryOutcomes': [{'measure': 'Genito-urinary (GU) toxicity', 'timeFrame': '6 weeks, 2 years and 5 years post treatment', 'description': 'Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brachytherapy', 'Monotherapy', 'HDR'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven Adenocarcinoma of the Prostate\n* Clinical stage T1c, T2a or T2b\n* PSA less than 20 ng/ml\n* Gleason Score 6 or 7\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Clinical stage T2c, T3 ou T4\n* Clinical Stage N1\n* Clinical Stage M1\n* Prostate Specific Antigen (PSA) more than 20 ng/ml\n* Gleason score 8 or higher\n* IPSS score 19 or higher with alpha-blockers\n* Past radiation therapy to the pelvis\n* History of Collagen Vascular Disease\n* History of Inflammatory Bowel Disease\n* Bilateral Hip Prosthesis'}, 'identificationModule': {'nctId': 'NCT02077335', 'briefTitle': 'Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'CSSS de Gatineau'}, 'officialTitle': 'Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'CSSSG-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HDR brachytherapy monotherapy', 'description': 'Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.', 'interventionNames': ['Radiation: HDR brachytherapy monotherapy']}], 'interventions': [{'name': 'HDR brachytherapy monotherapy', 'type': 'RADIATION', 'description': 'Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:\n\nProstate :\n\n* V100 \\> 95%\n* V150 30-35%\n* V200 \\< 15%\n* D90 \\> 90% (12,15Gy)\n\nBladder\n\n• V75 \\< 1cc\n\nRectum\n\n• V75 \\< 1cc\n\nUrethra\n\nV125 = 0cc D10 \\< 120%\n\nTreatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.', 'armGroupLabels': ['HDR brachytherapy monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J8P 7H2', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CSSS de Gatineau', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSSS de Gatineau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Marc Gaudet', 'investigatorAffiliation': 'CSSS de Gatineau'}}}}