Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-28 @ 6:20 AM
Study NCT ID:
NCT00392535
Status:
UNKNOWN
Last Update Posted:
2019-02-27
First Post:
2006-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensity-Modulated Radiation Therapy in Treating Patients With Localized 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-06-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2006-10-25', 'studyFirstSubmitQcDate': '2006-10-25', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to biochemical or clinical failure', 'timeFrame': 'Defined as the time from randomisation to biochemical failure or prostate cancer recurrence up to 5 years', 'description': 'Phoenix consensus guidelines as a PSA concentration greater than nadir plus 2 ng/mL.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'time from randomisation to any prostate cancer-related event or death from any cause up to 15 years'}, {'measure': 'Overall survival', 'timeFrame': 'Time from randomisation to death from any cause up to 15 years'}, {'measure': 'Development of metastases', 'timeFrame': 'Time from randomisation to development of metastases up to 15 years'}, {'measure': 'Recommencement of hormonal treatment for disease recurrence', 'timeFrame': 'Time from randomisation to recommencement of hormone treatment for disease recurrence up to 15 years'}, {'measure': 'Acute and late side-effects', 'timeFrame': 'Peak and week 18 bowel and bladder side-effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '27339115', 'type': 'RESULT', 'citation': "Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20."}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1186/ISRCTN97182923', 'label': 'ISRCTN registry'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which schedule of intensity-modulated radiation therapy is more effective in treating patients with prostate cancer.\n\nPURPOSE: This randomized phase III trial is studying the side effects of three schedules of intensity-modulated radiation therapy and compares how well they work in treating patients with localized prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and efficacy of conventional vs hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer.\n* Determine the side effects of these regimens in these patients.\n* Determine whether hypofractionated radiotherapy schedules will improve the therapeutic ratio by either improving tumor control or reducing normal tissue side effects.\n* Compare acute and late treatment-related gastrointestinal and urological toxicity in these patients.\n* Determine different prostate-specific antigen-related endpoints for local failure and distant metastases.\n* Extend the database of patients treated to escalated doses with dose-volume histograms (DVHs) of normal tissues at risk and relate these to common toxicity endpoints.\n* Develop a model to estimate normal tissue complication probability (NTCP) of rectum and bladder for hypofractionated as well as conventional dose-escalated radiotherapy schedules.\n\nOUTLINE: This is a multicenter, randomized, pilot study. Patients are stratified according to risk of seminal vesicle involvement (low-risk vs moderate-risk or high-risk).\n\n* Hormone therapy: Patients receive androgen-deprivation therapy comprising an injection of luteinizing hormone-releasing hormone (LHRH) agonist once monthly for 3-6 months and oral cyproterone acetate beginning the week before the first LHRH agonist injection and continuing for at least 2 weeks after each LHRH agonist injection. Within one week after the last LHRH agonist injection, patients proceed to radiotherapy.\n* Radiotherapy: Patients are randomized to 1 of 3 treatment arms.\n\n * Arm I: Patients undergo conventional high-dose intensity-modulated radiotherapy (IMRT) in 37 fractions over 7.5 weeks.\n * Arm II: Patients undergo hypofractionated high-dose IMRT in 20 fractions over 4 weeks.\n * Arm III: Patients undergo hypofractionated high-dose IMRT in 19 fractions over 3.8 weeks.\n\nIn all arms, treatment continues in the absence of unacceptable toxicity.\n\nQuality of life is assessed periodically during study treatment.\n\nAfter completion of study treatment, patients are followed periodically for up to 15 years.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 2,163 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:\n\n * Clinical stage T1b-T3a, N0, M0\n * Locally confined disease\n * Previously untreated disease\n* Prostate-specific antigen (PSA) ≤ 30 ng/mL\n* Estimated risk of seminal vesicle involvement \\< 30%\n\n * Estimated risk of seminal vesicle involvement is defined as PSA + (\\[Gleason score - 6\\] x 10) (i.e., if Gleason score ≤ 6, then PSA must be ≤ 30 ng/mL; if Gleason score = 7, then PSA must be \\< 20 ng/mL; if Gleason score = 8, then PSA must be \\< 10 ng/mL; if Gleason score = 9 or 10 patient is ineligible)\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0 or 1\n* Life expectancy \\> 10 years (5 years for patients with poorly differentiated cancers)\n* WBC \\> 4,000/mm\\^3\n* Hemoglobin \\> 11g/dL\n* Platelet count \\> 100,000/mm\\^3\n* No other active malignancy within the past 5 years except basal cell carcinoma\n* No hip prosthesis or fixation that would interfere with standard radiation beam configuration\n* No comorbid conditions likely to impact on the advisability of radical radiotherapy (e.g., previous inflammatory bowel disease, previous colorectal surgery, significant bladder instability, or urinary incontinence)\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior pelvic radiotherapy\n* No prior radical prostatectomy\n* No prior androgen-deprivation therapy\n* No concurrent full anticoagulation therapy with warfarin or heparin'}, 'identificationModule': {'nctId': 'NCT00392535', 'briefTitle': 'Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Cancer Research, United Kingdom'}, 'officialTitle': 'Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP', 'orgStudyIdInfo': {'id': 'CDR0000510112'}, 'secondaryIdInfos': [{'id': 'ICR-CTSU-CHHIP-2006-10007'}, {'id': 'ISRCTN97182923'}, {'id': 'EU-20646'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'conventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks)', 'interventionNames': ['Radiation: conventional radiotherapy 74 Gy delivered in 37 fractions']}, {'type': 'EXPERIMENTAL', 'label': 'Hypofractionated arm 1', 'description': 'Hypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)', 'interventionNames': ['Radiation: hypofractionated radiation therapy 60 Gy in 20 fractions']}, {'type': 'EXPERIMENTAL', 'label': 'Hypofractionated arm 2', 'description': 'Hypofractionated radiotherapy (57 Gy in 19 fractions over 3·8 weeks)', 'interventionNames': ['Radiation: hypofractionated radiation therapy 57 Gy in 19 fractions']}], 'interventions': [{'name': 'conventional radiotherapy 74 Gy delivered in 37 fractions', 'type': 'RADIATION', 'armGroupLabels': ['Control arm']}, {'name': 'hypofractionated radiation therapy 60 Gy in 20 fractions', 'type': 'RADIATION', 'armGroupLabels': ['Hypofractionated arm 1']}, {'name': 'hypofractionated radiation therapy 57 Gy in 19 fractions', 'type': 'RADIATION', 'armGroupLabels': ['Hypofractionated arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG24 9NA', 'city': 'Basingstoke', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Basingstoke and North Hampshire NHS Foundation Trust', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'zip': 'BN2 5BF', 'city': 'Brighton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sussex Cancer Centre at Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'IP33 2QZ', 'city': 'Bury St Edmunds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'West Suffolk Hospital', 'geoPoint': {'lat': 52.2463, 'lon': 0.71111}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CH2 1UL', 'city': 'Chester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Countess of Chester Hospital', 'geoPoint': {'lat': 53.1905, 'lon': -2.89189}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsgrave Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'BN21 2UD', 'city': 'Eastbourne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Eastbourne District General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. Luke's Cancer Centre at Royal Surrey County Hospital", 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'CH63 4JY', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'EC1A 7BE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Saint Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden - London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'L35 5DR', 'city': 'Prescot', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Whiston Hospital', 'geoPoint': {'lat': 53.42948, 'lon': -2.80031}}, {'zip': 'PR2 9HT', 'city': 'Preston', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Rosemere Cancer Centre at Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}, {'zip': 'WA7 2DA', 'city': 'Runcorn', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Halton Hospital', 'geoPoint': {'lat': 53.34174, 'lon': -2.73124}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'PR8 6PN', 'city': 'Southport', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southport and Formby District General Hospital', 'geoPoint': {'lat': 53.64581, 'lon': -3.01008}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'WA5 1QG', 'city': 'Warrington', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Warrington Hospital NHS Trust', 'geoPoint': {'lat': 53.39254, 'lon': -2.58024}}, {'zip': 'BN11 2DH', 'city': 'Worthing', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Worthing Hospital', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}, {'zip': 'BT8 8JR', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Center at Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'David P. Dearnaley, FRCR', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}