Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Status: | Completed |
---|---|
Conditions: | Prostate Cancer, Cancer, Cancer, Erectile Dysfunction, Other Indications, Psychiatric |
Therapuetic Areas: | Nephrology / Urology, Oncology, Psychiatry / Psychology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2003 |
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.
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.
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.
- 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.
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
We found this trial at
30
sites
One Medical Center Drive
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Inglewood, California 90301
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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Paoli Memorial Hospital Paoli is recognized regionally and nationally for outstanding medical and surgical services,...
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Salem, Ohio 44460
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LDS Hospital LDS Hospital provides clinical excellence to our community in a wide range of...
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3850 S National Ave
Springfield, Missouri 65807
Springfield, Missouri 65807
(417) 269-5257
Hulston Cancer Center at Cox Medical Center South In 1997, the cancer program at CoxHealth...
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100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
(484) 476-2000
Lankenau Cancer Center at Lankenau Hospital At Lankenau we pride ourselves on the breadth of...
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