Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

November 14, 2015 updated by: Radiation Therapy Oncology Group

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

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

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Concord, California, United States, 94524-4110
        • Mount Diablo Regional Cancer Center
      • Inglewood, California, United States, 90301
        • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
      • Walnut Creek, California, United States, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Massachusetts
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
    • Missouri
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Nevada
      • Reno, Nevada, United States, 89502
        • Washoe Cancer Services at Washoe Medical Center - Reno
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program - Marlton
      • Toms River, New Jersey, United States, 08755
        • Community Regional Cancer Center at Community Medical Center
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
    • Ohio
      • Akron, Ohio, United States, 44309-2090
        • Akron City Hospital
      • Salem, Ohio, United States, 44460
        • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
      • Wooster, Ohio, United States, 44691
        • Cancer Treatment Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
      • Tulsa, Oklahoma, United States, 74104
        • LaFortune Cancer Center at St. John Medical Center
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, United States, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Cancer Center
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Virginia
      • Portsmouth, Virginia, United States, 23708-2197
        • Naval Medical Center - Portsmouth
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Menomonee Falls, Wisconsin, United States, 53051
        • Community Memorial Hospital
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Deborah Watkins Bruner, RN, PhD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 14, 2015

Last Verified

November 1, 2015

More Information

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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