Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-04-15 @ 11:30 PM
Study NCT ID:
NCT01766492
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2013-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2013-01-09', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fatigue', 'timeFrame': '2 years', 'description': "Use questionnaire to assess patient's symptoms regarding fatigue"}, {'measure': 'urinary symptoms', 'timeFrame': '24 months', 'description': "Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery"}, {'measure': 'bowel symptoms', 'timeFrame': '24 months', 'description': "Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery"}, {'measure': 'sexual function', 'timeFrame': '24 months', 'description': "Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery"}], 'secondaryOutcomes': [{'measure': 'cancer control', 'timeFrame': '24 months', 'description': 'clinical evidence of localized and distal cancer controls'}, {'measure': 'toxicity symptoms', 'timeFrame': '24 months', 'description': 'Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'CyberKnife'], 'conditions': ['Prostate Cancer', 'Localized Malignant Neoplasm']}, 'referencesModule': {'references': [{'pmid': '17482880', 'type': 'BACKGROUND', 'citation': 'Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.'}, {'pmid': '29487023', 'type': 'DERIVED', 'citation': 'Dess RT, Devasia TP, Aghdam N, Jackson WC, Soni PD, Smith CP, Mitchell AL, Suy S, Hamstra DA, Jolly S, Nguyen PL, Feng FY, Schipper MJ, Skolarus TA, Miller DC, Wittmann DA, Collins SP, Spratt DE. Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):376-386. doi: 10.1016/j.ijrobp.2018.01.055. Epub 2018 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.', 'detailedDescription': 'Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):\n\nThe main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.\n\nHypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.\n\nPrimary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.\n\nSecondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men (\\> 18 y/o) with clinically localized prostate cancer,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of prostate\n* Signed study-specific consent\n* Prostate Specific Antigen (PSA) within 60 days of registration\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy\n* Prior radical prostate surgery\n* Medical or psychiatric illness that would interfere with treatment or follow up\n* Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery'}, 'identificationModule': {'nctId': 'NCT01766492', 'acronym': 'PR-PROS', 'briefTitle': 'Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)', 'orgStudyIdInfo': {'id': '2012-1175'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'male (age > 18 y/o) with prostate cancer', 'description': 'Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer', 'interventionNames': ['Radiation: Stereotactic Body Radiation Therapy (SBRT)']}], 'interventions': [{'name': 'Stereotactic Body Radiation Therapy (SBRT)', 'type': 'RADIATION', 'otherNames': ['CyberKnife radiosurgery'], 'description': 'Stereotactic body radiation therapy for prostate', 'armGroupLabels': ['male (age > 18 y/o) with prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robyn A Cyr', 'role': 'CONTACT', 'email': 'Robyn.A.Cyr@gunet.georgetown.edu', 'phone': '202-444-3068'}, {'name': 'Sean P Collins, MD, PhD', 'role': 'CONTACT', 'email': 'spc9@gunet.georgetown.edu', 'phone': '202-444-3292'}, {'name': 'Sean P Collins, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Malika T Danner', 'role': 'CONTACT', 'email': 'mtd@georgetown.edu', 'phone': '202-444-3068'}, {'name': 'Sean P Collins, MD, PhD', 'role': 'CONTACT', 'email': 'spc9@gunet.georgetown.edu', 'phone': '202-444-3292'}], 'overallOfficials': [{'name': 'Sean P Collins, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'NO individual data will be made available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}