- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057759
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
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.
PURPOSE: 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the effect of sildenafil vs placebo on erectile dysfunction in patients with prostate cancer treated with radiotherapy and antiandrogens on RTOG-9910.
- Compare the overall sexual function and satisfaction of patients treated with these regimens.
- Compare sexual satisfaction of partners of patients treated with these regimens.
- Compare patient and partner marital adjustment after treatment with these regimens.
- Determine factors that may predict response to sildenafil, including age, pretreatment sexual function, tobacco use, and comorbidities in these patients.
OUTLINE: 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.
- Arm I: Patients receive oral sildenafil 1 hour prior to desired sexual intercourse.
- Arm II: Patients receive oral placebo 1 hour prior to desired sexual intercourse.
Treatment on both arms continues for 12 weeks. Patients then cross over to treatment on the other arm for 12 weeks.
Quality of life, including sexual function, marital adjustment, and partner's satisfaction, is assessed at baseline, at 12 and 25 weeks, and at 1 year.
Patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Concord, California, United States, 94524-4110
- Mount Diablo Regional Cancer Center
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Inglewood, California, United States, 90301
- Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
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Walnut Creek, California, United States, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Massachusetts
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Hyannis, Massachusetts, United States, 02601
- Cape Cod Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Kalamazoo, Michigan, United States, 49007-3731
- West Michigan Cancer Center
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Missouri
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Springfield, Missouri, United States, 65804
- St. John's Regional Health Center
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Springfield, Missouri, United States, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nevada
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Reno, Nevada, United States, 89502
- Washoe Cancer Services at Washoe Medical Center - Reno
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Marlton, New Jersey, United States, 08053
- Fox Chase Virtua Health Cancer Program - Marlton
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Toms River, New Jersey, United States, 08755
- Community Regional Cancer Center at Community Medical Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Ohio
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Akron, Ohio, United States, 44309-2090
- Akron City Hospital
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Salem, Ohio, United States, 44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
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Wooster, Ohio, United States, 44691
- Cancer Treatment Center
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Tulsa, Oklahoma, United States, 74104
- LaFortune Cancer Center at St. John Medical Center
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- Bryn Mawr Hospital
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Paoli, Pennsylvania, United States, 19301-1792
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Cancer Center
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Utah
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Salt Lake City, Utah, United States, 84143
- LDS Hospital
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Virginia
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Portsmouth, Virginia, United States, 23708-2197
- Naval Medical Center - Portsmouth
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Menomonee Falls, Wisconsin, United States, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, United States, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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:
- T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 ng/mL but no greater than 100 ng/mL
- T1b-4, Gleason score 7, and PSA less than 20 ng/mL
- T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL
- Radiotherapy completed within the past 6 months to 5 years
Pretreatment (before enrollment on this study) erectile dysfunction as measured by International Index of Erectile Function Question #1
- Erectile dysfunction before starting prostate cancer therapy allowed
- Patients without partners or without partners willing to participate allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No myocardial infarction within the past year
Other
- No other invasive cancer within the past 5 years except localized basal cell or squamous cell skin cancer (stage 0-II)
- No anatomical genital abnormalities or concurrent conditions that would prohibit sexual intercourse or preclude study participation
- No other major medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- 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
Radiotherapy
- See Disease Characteristics
Surgery
- No prior penile implant
- No prior bilateral orchiectomy
Other
- No concurrent sildenafil
- No concurrent participation in another medical research study to treat prostate cancer
- No concurrent organic nitrate or requirement for nitrates (e.g., nitroglycerin as needed)
- No concurrent ketoconazole, itraconazole, or erythromycin
- No concurrent use of mechanical (vacuum) devices or intracorporeal, intraurethral, topical, or oral agents for erectile dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sildenafil citrate
Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
|
|
Placebo Comparator: Placebo
Placebo with similar "dose escalation" opportunity for 12 weeks.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ability to obtain an erection, as measured by question 1 on the IIEF
Time Frame: From baseline to 12 weeks from the start of drug after crossover
|
From baseline to 12 weeks from the start of drug after crossover
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall sexual function and satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)
Time Frame: From baseline to 12 weeks from the start of drug after crossover
|
From baseline to 12 weeks from the start of drug after crossover
|
Partner sexual satisfaction as measured by the SAQ-Partner
Time Frame: From baseline to 12 weeks from the start of drug after crossover
|
From baseline to 12 weeks from the start of drug after crossover
|
Patient and spouse marital adjustment as measured by the Locke's Marital Adjustment Test
Time Frame: From baseline to 12 weeks from the start of drug after crossover
|
From baseline to 12 weeks from the start of drug after crossover
|
Predictors of erectile dysfunction therapy
Time Frame: From baseline to 12 weeks from the start of drug after crossover
|
From baseline to 12 weeks from the start of drug after crossover
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Deborah Watkins Bruner, RN, PhD, Fox Chase Cancer Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Prostatic Neoplasms
- Erectile Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Sildenafil Citrate
Other Study ID Numbers
- RTOG-0215
- CDR0000269135
- NCI-P-02-0234
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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