Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT01540994
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'geoffrey.weinstein@sharp.com', 'phone': '858-939-5010', 'title': 'Dr. Geoffrey Weinstein', 'organization': 'Sharp Healthcare'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiation Therapy: Prostate Stereotactic Body Radiation Therapy', 'description': 'All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Late Genitourinary Toxicity (Grade 1)', 'notes': 'Frequency of urination or nocturia twice pretreatment habit/dysuria, urgency not requiring medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Late Gastrointestinal Toxicity (Grade 2)', 'notes': 'Moderate diarrhea and colic; bowel movement \\> 5 times daily; excessive rectal mucus or intermittent bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Rectal bleeding', 'notes': 'One patient hospitalized for rectal bleeding after completion of XRT, but colonoscopy showed diverticulitis without evidence of radiation changes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Genitourinary Toxicity (Grade 4)', 'notes': 'Bladder outlet obstruction requiring temporary foley catheter placement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy: Prostate Stereotactic Body Radiation Therapy', 'description': 'All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.'}], 'classes': [{'title': 'Acute Genitourinary Toxicity: 0 (none)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Acute Genitourinary Toxicity Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Genitourinary Toxicity Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Genitourinary Toxicity Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Genitourinary Toxicity Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Acute Genitourinary Toxicity Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Lower Gastrointestinal Toxicity: 0 (none)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Acute Lower Gastrointestinal Toxicity Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Lower Gastrointestinal Toxicity Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Lower Gastrointestinal Toxicity Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Lower Gastrointestinal Toxicity Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Lower Gastrointestinal Toxicity Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Genitourinary Toxicity: 0 (none)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Late Genitourinary Toxicity Grade 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Late Genitourinary Toxicity Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Genitourinary Toxicity Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Genitourinary Toxicity Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Genitourinary Toxicity Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Gastrointestinal Toxicity: 0 (none)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Late Gastrointestinal Toxicity Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Gastrointestinal Toxicity Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Late Gastrointestinal Toxicity Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Gastrointestinal Toxicity Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Late Gastrointestinal Toxicity Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.', 'description': 'Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 participants who were enrolled in the study'}, {'type': 'SECONDARY', 'title': 'Rate of Biochemical Disease-free Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy: Prostate Stereotactic Body Radiation Therapy', 'description': 'All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'mean 41 months (range 3-84 months)', 'description': 'Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have "biochemical failure" if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having "biochemical failure" will be deemed as "biochemically disease-free".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 participants who were enrolled in the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiation Therapy: Stereotactic Body Radiation Therapy', 'description': 'All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2011', 'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2018', 'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between 2011 and 2018 patients with prostate cancer were enrolled from the Radiation Oncology clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiation Therapy: Prostate Stereotactic Body Radiation Therapy', 'description': 'All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '12 patients received treatment as per protocol specifications.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Between 2011 and 2018, 12 patients were enrolled and received treatment as per protocol specifications.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-01-01', 'size': 114290, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-07T16:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2012-02-23', 'resultsFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-13', 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales.', 'timeFrame': 'Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.', 'description': 'Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant.'}], 'secondaryOutcomes': [{'measure': 'Rate of Biochemical Disease-free Status', 'timeFrame': 'mean 41 months (range 3-84 months)', 'description': 'Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have "biochemical failure" if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having "biochemical failure" will be deemed as "biochemically disease-free".'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neoplasms', 'Urogenital neoplasm', 'Genital neoplasms, male'], 'conditions': ['Prostatic Neoplasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.', 'detailedDescription': 'External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.\n\nExclusion Criteria:\n\n* Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4."}, 'identificationModule': {'nctId': 'NCT01540994', 'briefTitle': 'Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate', 'orgStudyIdInfo': {'id': '101091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic Body Radiation Therapy', 'description': 'Stereotactic Body Radiation Therapy', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'Stereotactic Body Radiation Therapy', 'armGroupLabels': ['Stereotactic Body Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Geoffrey Weinstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp HealthCare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Radiation Oncology', 'investigatorFullName': 'Geoffrey Weinstein, M.D.', 'investigatorAffiliation': 'Sharp HealthCare'}}}}