Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057759
• Other study ID #: RTOG-0215
• Secondary ID: CDR0000269135NCI
• Status: Completed
• Phase: N/A
• First received: April 7, 2003
• Last updated: November 14, 2015
• Start date: January 2003

Study information

• Verified date: November 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00075127

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment
• Radiation Injuries
• Radiation Toxicity
• Sexual Dysfunction
• Sexuality and Reproductive Issues

Intervention

Drug:
• sildenafil citrate

Other:
• Placebo
Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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 — View 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 ra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to obtain an erection, as measured by question 1 on the IIEF		From baseline to 12 weeks from the start of drug after crossover	No
Secondary	Overall sexual function and satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)		From baseline to 12 weeks from the start of drug after crossover	No
Secondary	Partner sexual satisfaction as measured by the SAQ-Partner		From baseline to 12 weeks from the start of drug after crossover	No
Secondary	Patient and spouse marital adjustment as measured by the Locke's Marital Adjustment Test		From baseline to 12 weeks from the start of drug after crossover	No
Secondary	Predictors of erectile dysfunction therapy		From baseline to 12 weeks from the start of drug after crossover	No