Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT01578902
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2011-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrew.loblaw@sunnybrook.ca', 'phone': '4164804806', 'title': 'Dr Andrew Loblaw, Director GU Radiation Trials', 'organization': 'Sunnybrook Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hypofractionated Radiation', 'description': '35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.\n\nThe co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.', 'otherNumAtRisk': 84, 'otherNumAffected': 34, 'seriousNumAtRisk': 84, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'acute grade 2 genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute grade 2 gastrointestinal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'late grade 2 gastrointestinal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'late grade 2 genitourinary toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'late grade 3+ GI toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'late grade 3+ GU toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute grade 3+ GU toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'acute urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rectalcutaneous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Grade 3+ Gastrointestinal Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypofractionated Radiation', 'description': '35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.\n\nThe co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Acute period (up to 6 months)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v3.0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Grade 3+ Genitourinary Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypofractionated Radiation', 'description': '35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.\n\nThe co-primary endpoint (Grade 3+ acute genitourinary toxicity) was observed in 1% (1/84) patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Acute (up to 6 months) and Late (6 months and after)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v3.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Grade 3+ Rectal and Urinary Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypofractionated Radiation', 'description': '35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.\n\nHypofractionated radiotherapy: 35Gy/5 fractions/29 days'}], 'classes': [{'title': 'Acute GU grade 3+ toxicity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Acute GI grade 3+ toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late GU grade 3+ toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late GI grade 3+ toxicity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Late (6 months and after)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v3.0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'low risk prostate cancer patients were treated with SABR 35Gy in 5 fractions over 29 days'}, {'type': 'SECONDARY', 'title': 'Patient Reported Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypofractionated Radiotherapy Using SABR', 'description': 'Stereotactic radiation: 35Gy in 5 fractions over 29 days\n\nStereotactic ablative body radiotherapy: 35Gy/5 fractions/29 days'}], 'classes': [{'title': 'Bowel quality of life change', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Bladder quality of life change', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Sexual quality of life change', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Expanded Prostate Cancer Index Composite (EPIC)', 'unitOfMeasure': 'percentage with change in QOL', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were low risk prostate cancer patients treated with SABR 35Gy in 5 fractions over 29 days.'}, {'type': 'SECONDARY', 'title': 'Biochemical (ie. Prostate Specific Antigen) Disease Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypofractionated Radiation', 'description': '35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.\n\nHypofractionated radiotherapy: 35Gy/5 fractions/29 days'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 year', 'description': 'Failure = Follow-up PSA greater than nadir PSA + 2 ng/ml', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'low risk prostate cancer patients treated with SABR 35 Gy in 5 fractions over 29 days'}, {'type': 'SECONDARY', 'title': 'Biopsy Positive Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypofractionated Radiation', 'description': '35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.\n\nHypofractionated radiotherapy: 35Gy/5 fractions/29 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 year', 'description': 'Patients were biopsied at 3 years post treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'low risk prostate cancer patients treated with SABR 35 Gy in 5 fractions over 29 days'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypofractionated Radiation', 'description': '35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.\n\nHypofractionated radiotherapy: 35Gy/5 fractions/29 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were prospectively recruited from the Odette Cancer Centre from Oct 2006 to July 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'Inclusion criteria were men over 18 years of age with histologically confirmed diagnosis of adenocarcinoma of the prostate. Only patients with clinical stage T1-T2b (TNM 2002) \\[18\\] Gleason Sum 66 and PSA 610 ng/ml were eligible. Neoadjuvant androgen deprivation therapy (ADT) was allowed for cytoreduction. Patients were excluded if they had prior pelvic radiation therapy, a bleeding diathesis which precluded safe gold seed insertion, the presence of hip prosthesis or pelvic girth \\>40 cm. Lastly, prostate size \\>90cm3 on imaging or severe lower urinary tract symptoms (IPSS \\> 19)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2011-10-31', 'resultsFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2012-04-13', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-23', 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Grade 3+ Gastrointestinal Toxicity', 'timeFrame': 'Acute period (up to 6 months)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v3.0'}], 'secondaryOutcomes': [{'measure': 'Incidence of Grade 3+ Genitourinary Toxicity', 'timeFrame': 'Acute (up to 6 months) and Late (6 months and after)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v3.0'}, {'measure': 'Incidence of Grade 3+ Rectal and Urinary Toxicity', 'timeFrame': 'Late (6 months and after)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v3.0'}, {'measure': 'Patient Reported Quality of Life', 'timeFrame': 'up to 5 years', 'description': 'Expanded Prostate Cancer Index Composite (EPIC)'}, {'measure': 'Biochemical (ie. Prostate Specific Antigen) Disease Free Survival', 'timeFrame': '5 year', 'description': 'Failure = Follow-up PSA greater than nadir PSA + 2 ng/ml'}, {'measure': 'Biopsy Positive Rate', 'timeFrame': '3 year', 'description': 'Patients were biopsied at 3 years post treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostatic Neoplasms', 'Radiotherapy', 'Hypofractionation', 'Low Risk Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '27622157', 'type': 'DERIVED', 'citation': "Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.', 'detailedDescription': 'Rationale for Proposed Study With the availability of intensity modulated radiotherapy (IMRT) at the Odette Cancer Centre (OCC), there is an opportunity to explore the use of a much more intensive hypofractionation schedule for prostate cancer. Using an alpha/beta ratio of 1.3, a dose of 35 Gy in 5 fractions would be equivalent to 88 Gy delivered in 2 Gy fractions. For normal tissues (alpha/beta value of 2), this would be equivalent to 78 Gy in 2 Gy fractions. As such, the linear quadratic equation predicts that 35 Gy in 5 fractions should not result in any increased late toxicity for normal tissues compared to standard dose escalated radiotherapy. However, the biological dose to the prostate cancer would be significantly increased. As a safety precaution for this study proposal, the investigators propose to deliver 35 Gy in 5 fractions over 5 weeks (one radiotherapy fraction of 7 Gy per week) to allow for normal tissue repair.\n\nWith IMRT, it is expected that there will be superior conformality of the high dose region around the target volume. As well, the use of daily on-line imaging will allow us to eliminate interfraction prostate motion errors and use tighter planning target volume margins for any residual intrafraction motion. At OCC, such an approach has already been shown to be feasible and is currently employed in the phase 1/2 concomitant boost study for high risk prostate cancer.\n\nIf proven to be safe and effective, such a hypofractionated radiotherapy schedule may have significant practical advantages as well. With only 1 fraction of radiotherapy delivered each week (for a total of 5 weeks), there are huge savings in resource utilization and increased convenience for patients.\n\nThe investigators propose to start a small phase 1 study to explore the use of this dose fractionation for men with low risk prostate cancer. The primary endpoint for this small pilot study would be acute and late normal tissue toxicities. If proven to be feasible and safe, external peer-reviewed funding will be sought to further explore this novel treatment schedule in a larger phase 2 setting.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed (Appendix A)\n* Adult men greater than 18 years of age\n* Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).\n* Clinical stage T1-T2b, Gleason Score \\< 6, and PSA \\< 10 ng/mL\n* Less than 50% of biopsy cores +ve for cancer\n* Less than 50% overall surface area involved with cancer\n* Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been performed within 2 months of starting androgen suppression therapy. If androgen suppression therapy has been started LHRH agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion \\& radiotherapy planning.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)\n* Diagnosis of bleeding diathesis\n* Presence of a hip prosthesis\n* Pelvic girth \\>40cm (to ensure visibility of gold seeds on electronic portal imaging device)\n* Large prostate (\\> 60 cm3) on imaging\n* Severe lower urinary tract symptoms (International Prostate Symptom Score \\> 15 or nocturia \\> 3)'}, 'identificationModule': {'nctId': 'NCT01578902', 'acronym': 'pHART3', 'briefTitle': 'Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)', 'orgStudyIdInfo': {'id': '371-2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated radiotherapy using SABR', 'description': 'Stereotactic radiation: 35Gy in 5 fractions over 29 days', 'interventionNames': ['Radiation: Stereotactic ablative body radiotherapy']}], 'interventions': [{'name': 'Stereotactic ablative body radiotherapy', 'type': 'RADIATION', 'otherNames': ['standard linear accelerator delivery'], 'description': '35Gy/5 fractions/29 days', 'armGroupLabels': ['Hypofractionated radiotherapy using SABR']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Andrew Loblaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}, {'name': 'Patrick Cheung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Association of Radiation Oncology', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}