Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-03-15 @ 5:38 PM
Study NCT ID:
NCT00057759
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2003-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D019529', 'term': 'Sexuality'}], '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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-14', 'studyFirstSubmitDate': '2003-04-07', 'studyFirstSubmitQcDate': '2003-04-08', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to obtain an erection, as measured by question 1 on the IIEF', 'timeFrame': 'From baseline to 12 weeks from the start of drug after crossover'}], 'secondaryOutcomes': [{'measure': 'Overall sexual function and satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)', 'timeFrame': 'From baseline to 12 weeks from the start of drug after crossover'}, {'measure': 'Partner sexual satisfaction as measured by the SAQ-Partner', 'timeFrame': 'From baseline to 12 weeks from the start of drug after crossover'}, {'measure': "Patient and spouse marital adjustment as measured by the Locke's Marital Adjustment Test", 'timeFrame': 'From baseline to 12 weeks from the start of drug after crossover'}, {'measure': 'Predictors of erectile dysfunction therapy', 'timeFrame': 'From baseline to 12 weeks from the start of drug after crossover'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sexual dysfunction', 'sexuality and reproductive issues', 'radiation toxicity', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer', 'psychosocial effects of cancer and its treatment'], 'conditions': ['Prostate Cancer', 'Psychosocial Effects of Cancer and Its Treatment', 'Radiation Toxicity', 'Sexual Dysfunction', 'Sexuality and Reproductive Issues']}, 'referencesModule': {'references': [{'pmid': '22354624', 'type': 'RESULT', 'citation': 'Hanisch LJ, Bryan CJ, James JL, Pisansky TM, Corbett TB, Parliament MB, Stewart CE, Hartford AC, Sandler H, Berk LB, Kachnic L, Bruner DW. Impact of sildenafil on marital and sexual adjustment in patients and their wives after radiotherapy and short-term androgen suppression for prostate cancer: analysis of RTOG 0215. Support Care Cancer. 2012 Nov;20(11):2845-50. doi: 10.1007/s00520-012-1409-8. Epub 2012 Feb 22.'}, {'pmid': '21235716', 'type': 'RESULT', 'citation': 'Watkins Bruner D, James JL, Bryan CJ, Pisansky TM, Rotman M, Corbett T, Speight J, Byhardt R, Sandler H, Bentzen S, Kachnic L, Berk L. Randomized, double-blinded, placebo-controlled crossover trial of treating erectile dysfunction with sildenafil after radiotherapy and short-term androgen deprivation therapy: results of RTOG 0215. J Sex Med. 2011 Apr;8(4):1228-38. doi: 10.1111/j.1743-6109.2010.02164.x. Epub 2011 Jan 14.'}, {'type': 'RESULT', 'citation': 'Bruner DW, James J, Pisansky TM, et al.: RTOG 0215 treatment of erectile dysfunction (ED) in patients treated with neoadjuvant and concurrent androgen deprivation (AD) and radiotherapy (RT) for prostate cancer (PC). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-52, S30, 2007.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life.\n\nPURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.', 'detailedDescription': "OBJECTIVES:\n\n* Compare the effect of sildenafil vs placebo on erectile dysfunction in patients with prostate cancer treated with radiotherapy and antiandrogens on RTOG-9910.\n* Compare the overall sexual function and satisfaction of patients treated with these regimens.\n* Compare sexual satisfaction of partners of patients treated with these regimens.\n* Compare patient and partner marital adjustment after treatment with these regimens.\n* Determine factors that may predict response to sildenafil, including age, pretreatment sexual function, tobacco use, and comorbidities in these patients.\n\nOUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to prior use of sildenafil after treatment on RTOG-9910 and level of response (No vs yes \\[unsatisfactory\\] vs yes \\[satisfactory\\]), International Index of Erectile Function (IIEF) Question #1 score (0-1 vs 2-3), and RTOG-9910 treatment arm (I vs II). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral sildenafil 1 hour prior to desired sexual intercourse.\n* Arm II: Patients receive oral placebo 1 hour prior to desired sexual intercourse.\n\nTreatment on both arms continues for 12 weeks. Patients then cross over to treatment on the other arm for 12 weeks.\n\nQuality of life, including sexual function, marital adjustment, and partner's satisfaction, is assessed at baseline, at 12 and 25 weeks, and at 1 year.\n\nPatients are followed at 1 year.\n\nPROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Prior treatment on RTOG-9910 for intermediate relapse-risk stage II or III prostate cancer as determined by any of the following combinations of factors:\n\n * T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 ng/mL but no greater than 100 ng/mL\n * T1b-4, Gleason score 7, and PSA less than 20 ng/mL\n * T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL\n* Radiotherapy completed within the past 6 months to 5 years\n* Pretreatment (before enrollment on this study) erectile dysfunction as measured by International Index of Erectile Function Question #1\n\n * Erectile dysfunction before starting prostate cancer therapy allowed\n* Patients without partners or without partners willing to participate allowed\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No myocardial infarction within the past year\n\nOther\n\n* No other invasive cancer within the past 5 years except localized basal cell or squamous cell skin cancer (stage 0-II)\n* No anatomical genital abnormalities or concurrent conditions that would prohibit sexual intercourse or preclude study participation\n* No other major medical or psychiatric illness that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* More than 6 months since prior androgen suppression (e.g., leuprolide or goserelin), antiandrogen (e.g., bicalutamide, flutamide, or nilutamide), or estrogenic (e.g., diethylstilbestrol) agents\n\nRadiotherapy\n\n* See Disease Characteristics\n\nSurgery\n\n* No prior penile implant\n* No prior bilateral orchiectomy\n\nOther\n\n* No concurrent sildenafil\n* No concurrent participation in another medical research study to treat prostate cancer\n* No concurrent organic nitrate or requirement for nitrates (e.g., nitroglycerin as needed)\n* No concurrent ketoconazole, itraconazole, or erythromycin\n* No concurrent use of mechanical (vacuum) devices or intracorporeal, intraurethral, topical, or oral agents for erectile dysfunction'}, 'identificationModule': {'nctId': 'NCT00057759', 'briefTitle': 'Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer', 'nctIdAliases': ['NCT00075127'], 'organization': {'class': 'NETWORK', 'fullName': 'Radiation Therapy Oncology Group'}, 'officialTitle': 'Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life', 'orgStudyIdInfo': {'id': 'RTOG-0215'}, 'secondaryIdInfos': [{'id': 'CDR0000269135'}, {'id': 'NCI-P-02-0234'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil citrate', 'description': 'Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.', 'interventionNames': ['Drug: sildenafil citrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo with similar "dose escalation" opportunity for 12 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'sildenafil citrate', 'type': 'DRUG', 'armGroupLabels': ['Sildenafil citrate']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94524-4110', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Mount Diablo Regional Cancer Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'John Muir/Mt. Diablo Comprehensive Cancer Center', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '02601', 'city': 'Hyannis', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cape Cod Hospital', 'geoPoint': {'lat': 41.65289, 'lon': -70.2828}}, {'zip': '48109-0942', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49007-3731', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Regional Health Center", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Hulston Cancer Center at Cox Medical Center South', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Washoe Cancer Services at Washoe Medical Center - Reno', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Fox Chase Virtua Health Cancer Program - Marlton', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Community Regional Cancer Center at Community Medical Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '44309-2090', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron City Hospital', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44460', 'city': 'Salem', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford', 'geoPoint': {'lat': 40.90089, 'lon': -80.85675}}, {'zip': '44691', 'city': 'Wooster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cancer Treatment Center', 'geoPoint': {'lat': 40.80517, 'lon': -81.93646}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'LaFortune Cancer Center at St. John Medical Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Natalie Warren Bryant Cancer Center at St. Francis Hospital', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bryn Mawr Hospital', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '19301-1792', 'city': 'Paoli', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paoli Memorial Hospital', 'geoPoint': {'lat': 40.04205, 'lon': -75.47631}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CCOP - MainLine Health', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Cancer Center at Lankenau Hospital', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23708-2197', 'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center - Portsmouth', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}, {'zip': '53051', 'city': 'Menomonee Falls', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Community Memorial Hospital', 'geoPoint': {'lat': 43.1789, 'lon': -88.11731}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin Cancer Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Milwaukee (Zablocki)', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Deborah Watkins Bruner, RN, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radiation Therapy Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}