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Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity Sexual Dysfunction Sexuality and Reproductive Issues Drug: sildenafil citrate Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
Study Start Date : January 2003
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sildenafil citrate
Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
 Drug: sildenafil citrate
Placebo Comparator: Placebo
Placebo with similar "dose escalation" opportunity for 12 weeks.
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Partner sexual satisfaction as measured by the SAQ-Partner [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ]
  3. 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 ]
  4. Predictors of erectile dysfunction therapy [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057759


Locations
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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Deborah Watkins Bruner, RN, PhD Fox Chase Cancer Center
More Information
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Publications of Results:
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.

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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00057759    
Obsolete Identifiers: NCT00075127
Other Study ID Numbers: RTOG-0215
CDR0000269135
NCI-P-02-0234
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Radiation Therapy Oncology Group:
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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
 Mental Disorders
Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents