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Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00057759
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date  ICMJE April 7, 2003
First Posted Date  ICMJE April 9, 2003
Last Update Posted Date November 17, 2015
Study Start Date  ICMJE January 2003
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00057759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
  • 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 ]
  • Partner sexual satisfaction as measured by the SAQ-Partner [ Time Frame: 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 ]
  • Predictors of erectile dysfunction therapy [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Official Title  ICMJE Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
Intervention  ICMJE
  • Drug: sildenafil citrate
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Sildenafil citrate
    Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
    Intervention: Drug: sildenafil citrate
  • Placebo Comparator: Placebo
    Placebo with similar "dose escalation" opportunity for 12 weeks.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2013)
115
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00057759
Other Study ID Numbers  ICMJE RTOG-0215
CDR0000269135
NCI-P-02-0234
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radiation Therapy Oncology Group
Study Sponsor  ICMJE Radiation Therapy Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Deborah Watkins Bruner, RN, PhD Fox Chase Cancer Center
PRS Account Radiation Therapy Oncology Group
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP