Clinical trial NCT00057759: Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Official title: Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexual Dysfunction
Sexuality and Reproductive Issues
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
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-09
Enrollment: 115
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility 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., 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Concord
country: United States
facility: Mount Diablo Regional Cancer Center
state: California
city: Inglewood
country: United States
facility: Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
state: California
city: Walnut Creek
country: United States
facility: John Muir/Mt. Diablo Comprehensive Cancer Center
state: California
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Springfield
country: United States
facility: St. John's Regional Health Center
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center at Cox Medical Center South
state: Missouri
city: Reno
country: United States
facility: Washoe Cancer Services at Washoe Medical Center - Reno
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Marlton
country: United States
facility: Fox Chase Virtua Health Cancer Program - Marlton
state: New Jersey
city: Toms River
country: United States
facility: Community Regional Cancer Center at Community Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Salem
country: United States
facility: Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
state: Ohio
city: Wooster
country: United States
facility: Cancer Treatment Center
state: Ohio
city: Tulsa
country: United States
facility: LaFortune Cancer Center at St. John Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Natalie Warren Bryant Cancer Center at St. Francis Hospital
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Cancer Center at Lankenau Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Portsmouth
country: United States
facility: Naval Medical Center - Portsmouth
state: Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Community Memorial Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
Study officials:
affiliation: Fox Chase Cancer Center
name: Deborah Watkins Bruner, RN, PhD
role: STUDY_CHAIR
References:
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.
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.
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.