Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT00969202
Status:
UNKNOWN
Last Update Posted:
2015-11-18
First Post:
2009-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stereotactic Hypofractionated Radiosurgery for Early Stage 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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA decline measured through laboratory testing.', 'timeFrame': 'One month following radiosurgery through 5 year follow up'}], 'secondaryOutcomes': [{'measure': 'Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.', 'timeFrame': 'One month following radiosurgery through 5 years follow up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Cancer of the Prostate', 'Prostate Tumor', 'Novalis Tx', 'Novalis', 'Stereotactic Radiosurgery', 'Radiosurgery', 'Radiation'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.\n\nThe investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Gleason score ≤ 6 and low volume Gleason 7 (3+4)\n* PSA \\< 10\n* Clinical Stage of T2a or less\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior radiation treatment for prostate cancer\n* Gleason score \\> 7\n* PSA \\> 10\n* Clinical Stage of T2b or greater'}, 'identificationModule': {'nctId': 'NCT00969202', 'briefTitle': 'Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'San Diego Radiosurgery'}, 'officialTitle': 'Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage', 'orgStudyIdInfo': {'id': 'SDRS0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic Radiosurgery using NovalisTx', 'description': 'Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.', 'interventionNames': ['Radiation: Stereotactic Radiosurgery using the Novalis Tx']}], 'interventions': [{'name': 'Stereotactic Radiosurgery using the Novalis Tx', 'type': 'RADIATION', 'otherNames': ['Novalis Tx', 'Novalis'], 'description': 'Five treatments given every other day.', 'armGroupLabels': ['Stereotactic Radiosurgery using NovalisTx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92025', 'city': 'Escondido', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Joiner', 'role': 'CONTACT', 'email': 'Jennifer.joiner@palomarhealth.org', 'phone': '760-739-3185'}, {'name': 'Lori A Coleman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'P. Brian Volpp, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kelly D Dewitt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Barry Uhl, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Geoffrey Weinstein, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Phillip Zentner, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'San Diego Radiosurgery at Palomar Medical Center', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}], 'centralContacts': [{'name': 'Jennifer Joiner', 'role': 'CONTACT', 'email': 'Jennifer.joiner@palomarhealth.org', 'phone': '760-739-3185'}, {'name': 'Jeremy Legg', 'role': 'CONTACT', 'email': 'jlegg@Allianceoncology.com', 'phone': '615-920-1282'}], 'overallOfficials': [{'name': 'P. Brian Volpp, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego Radiosurgery', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}