Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-03-12 @ 5:54 PM
Study NCT ID:
NCT02370992
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I125 Brachytherapy After TURP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4.', 'timeFrame': 'Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly', 'description': 'This change will be measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly'}], 'secondaryOutcomes': [{'measure': 'Gastro-intestinal and sexual function', 'timeFrame': 'Measured at 1 mth.', 'description': 'Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)'}, {'measure': 'Gastro-intestinal and sexual function', 'timeFrame': 'Measured at 3 mth.', 'description': 'Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)'}, {'measure': 'Gastro-intestinal and sexual function', 'timeFrame': 'Measured at 6 mth.', 'description': 'Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)'}, {'measure': 'Gastro-intestinal and sexual function', 'timeFrame': 'Measured at 12 mth.', 'description': 'Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when the technique was being developed in the 1980s suggested that there was a higher incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It is however clear that with increasing experience many centres offer this treatment to patients who have had previous TURP, using various parameters to select patients including time from the TURP and persence or absence of a significant cavity within the gland on MRI scanning. There has been no systematic study of I125 brachytherapy after TURP in the current era which might address and inform the practice for future patient. Hence this study is designed to formally assess the safety of I125 brachytherapy after previous TURP.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients taking part will do so having chosen I125 brachytherapy as their chosen treatment for prostate cancer and will have previously undergone TURP', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* WHO performance status 0-1\n* No contra-indication for anaesthesia\n* No history of irradiation of the pelvis\n* No other oncologic malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient is disease free for at least 5 years.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;\n\nProstate (cancer) related:\n\n* Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D'Amico classification.\n* Prostate volume \\< 50 cc as measured on transrectal ultrasound\n* Neo-adjuvant antiandrogen hormonal treatment is permitted to downsize the prostate volume or to cover waiting time till brachytherapy procedure. No adjuvant hormonal treatment is permitted.\n* History of TransUrethral Resection of the prostate (TURp), performed at least 3 months before the brachytherapy procedure.\n* Rim of prostate tissue of at least 1 cm around the post-TURp urethral defect at thepostero-lateral sides of the prostate\n* Absence of significant TURp-induced urinary incontinence\n* IPSS \\<15\n\nExclusion Criteria:\n\n* Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer High grade tumours defined by Gleason score 8 or above Co-morbidity which would exclude the patient from a transperineal implant procedure.\n\nUnable to give informed consent."}, 'identificationModule': {'nctId': 'NCT02370992', 'briefTitle': 'I125 Brachytherapy After TURP', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection', 'orgStudyIdInfo': {'id': 'CO11/9837'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Receiving I125 brachytherapy', 'description': 'I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice', 'interventionNames': ['Radiation: I125 brachytherapy']}], 'interventions': [{'name': 'I125 brachytherapy', 'type': 'RADIATION', 'description': 'I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice', 'armGroupLabels': ['Receiving I125 brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'The Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}