Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
18 Years
N/A
Male
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity, Sexual Dysfunction, Sexuality and Reproductive Issues
Trial Information
Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
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 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.
Inclusion Criteria
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.,
diethylstibestrol) 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Deborah Watkins Bruner, RN, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000269135
NCT ID:
NCT00057759
Start Date:
January 2003
Completion Date:
Related Keywords:
- Prostate Cancer
- Psychosocial Effects of Cancer and Its Treatment
- Radiation Toxicity
- Sexual Dysfunction
- Sexuality and Reproductive Issues
- 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
- Prostatic Neoplasms
- Sexual Dysfunctions, Psychological
- Erectile Dysfunction
- Radiation Injuries
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Cape Cod Hospital | Hyannis, Massachusetts 02601 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
| Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
| Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
| Mount Diablo Regional Cancer Center | Concord, California 94524-4110 |
| John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
| LaFortune Cancer Center at St. John Medical Center | Tulsa, Oklahoma 74104 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Washoe Cancer Services at Washoe Medical Center - Reno | Reno, Nevada 89502 |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | Inglewood, California 90301 |
| Community Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
