Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-29 @ 3:37 AM
Study NCT ID:
NCT00304759
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2006-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROFIT - Prostate Fractionated Irradiation Trial
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-28', 'studyFirstSubmitDate': '2006-03-17', 'studyFirstSubmitQcDate': '2006-03-17', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical (PSA) Failure', 'timeFrame': 'five years'}], 'secondaryOutcomes': [{'measure': 'Biochemical-Clinical Failure', 'timeFrame': 'five years'}, {'measure': 'Prostate Cancer Specific Mortality', 'timeFrame': 'five years'}, {'measure': 'Toxicity', 'timeFrame': 'five years'}, {'measure': 'Quality of Life', 'timeFrame': 'five years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer', 'localized prostate cancer', 'intermediate risk', 'prostate specific antigen', 'PSA', 'radiation fractionation', 'shorter schedule', 'quality of life'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '23751377', 'type': 'BACKGROUND', 'citation': 'Martin J, Frantzis J, Chung P, Langah I, Crain M, Cornes D, Plank A, Finch T, Jones M, Khoo E, Catton C. Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project). Radiother Oncol. 2013 Jun;107(3):333-8. doi: 10.1016/j.radonc.2013.05.015. Epub 2013 Jun 8.'}, {'pmid': '40335398', 'type': 'DERIVED', 'citation': 'Sanmamed N, Dayes I, Catton C, Liu A, Supiot S, Lukka H, Bauman G, Liu Z, Bahary JP, Ahmed S, Cheung P, Parliament M, Sia M, Tsakiridis T, Siva S, Corbett T, Tang C, Craig T, Martin J, Chung P. Patient-reported Quality of Life in PROFIT, a Phase 3 Randomized Clinical Trial Evaluating Moderately Hypofractionated Radiotherapy for Intermediate-risk Prostate Cancer. Eur Urol Oncol. 2025 May 6:S2588-9311(25)00095-1. doi: 10.1016/j.euo.2025.03.017. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.', 'detailedDescription': 'In this trial, men with intermediate risk prostate cancer will be randomized to a shorter course of radiotherapy (6000cGy in 20 fractions over 4 weeks-hypofractionated) or treatment with a conventional fractionation course (7800cGy in 39 fractions over 8 weeks-standard). Three-dimensional conformal radiation treatment techniques, including intensity modulated radiotherapy will be used for both hypofractionated and standard treatments to avoid normal tissue exposure to radiation and minimize the risk of acute and late treatment related toxicity. The primary outcome measure is biochemical (PSA) failure defined by the ASTRO consensus criteria. Secondary outcomes include biochemical-clinical failure (BCF), mortality from cancer, toxicity and health-related quality of life. It is planned to recruit 1204 patients to the study. If the safety and efficacy of the shorter course are demonstrated, then its adoption would reduce the social, emotional and economic burden of treatment for patients and their families.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;\n2. Intermediate risk prostate cancer (that is, T1-2a, Gleason score \\<6, PSA 10.1-20.0 ng/ml; T2b-c Gleason \\<6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ml).\n\nExclusion Criteria:\n\n1. Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;\n2. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;\n3. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;\n4. Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer;\n5. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;\n6. Previous pelvic radiotherapy;\n7. Inflammatory bowel disease.'}, 'identificationModule': {'nctId': 'NCT00304759', 'briefTitle': 'PROFIT - Prostate Fractionated Irradiation Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ontario Clinical Oncology Group (OCOG)'}, 'officialTitle': 'A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'OCOG-2005-PROFIT'}, 'secondaryIdInfos': [{'id': 'CIHR grant MCT-78776'}, {'id': 'ISRCTN43853433'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '6000 cGy / 20 fractions in 4 weeks', 'interventionNames': ['Procedure: 6000 cGy/20 fractions in 4 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '7800 cGy / 39 fractions in 8 weeks', 'interventionNames': ['Procedure: 7800 cGy/39 fractions in 8 weeks']}], 'interventions': [{'name': '7800 cGy/39 fractions in 8 weeks', 'type': 'PROCEDURE', 'otherNames': ['standard'], 'description': 'see above', 'armGroupLabels': ['2']}, {'name': '6000 cGy/20 fractions in 4 weeks', 'type': 'PROCEDURE', 'otherNames': ['short fractionation schedule'], 'description': 'see above', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital & Campbelltown Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2310', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Northern Sydney Cancer Centre, Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2145', 'city': 'Wentworthville', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Cancer Care Centre', 'geoPoint': {'lat': -33.80652, 'lon': 150.96785}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Wollongong Hospital / Illawarra Cancer Care Centre', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4350', 'city': 'Toowoomba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Toowoomba Cancer Research Centre', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3350', 'city': 'Ballarat', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Ballarat Austin Radiation Oncology Centre (BAROC)', 'geoPoint': {'lat': -37.56622, 'lon': 143.84957}}, {'zip': '8006', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'T4N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Dr. H. Bliss Murphy Cancer Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5M 2N1', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Stronach Regional Cancer Centre, Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'R.S. McLaughlin Durham Regional Cancer Centre', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Sunnybrook Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 1L9', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Regional Cancer Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Hôpital Notre-Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montréal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S4T 7T1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': '44093', 'city': 'Nantes', 'state': 'Saint Herblain', 'country': 'France', 'facility': 'Centre René Gauducheau', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Charles Catton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Hospital, Canada'}, {'name': 'Himu Lukka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Juravinski Cancer Centre'}, {'name': 'Mark Levine, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ontario Clinical Oncology Group (OCOG)'}, {'name': 'Jim Julian, MMATH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University - Department of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ontario Clinical Oncology Group (OCOG)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Trans Tasman Radiation Oncology Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}