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NCT00057759 · CITED IN SOURCE DOCUMENTS

Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
COMPLETED
Registry last update
2015-11-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
    intervention Names
    1. Drug: sildenafil citrate
    label
    Sildenafil citrate
    type
    EXPERIMENTAL
  2. description
    Placebo with similar "dose escalation" opportunity for 12 weeks.
    intervention Names
    1. Other: Placebo
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Sildenafil citrate
    name
    sildenafil citrate
    type
    DRUG
  2. arm Group Labels
    1. Placebo
    description
    Placebo
    name
    Placebo
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
CROSSOVER
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
115
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    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 Outcomes
  1. measure
    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. measure
    Partner sexual satisfaction as measured by the SAQ-Partner
    time Frame
    From baseline to 12 weeks from the start of drug after crossover
  3. measure
    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. measure
    Predictors of erectile dysfunction therapy
    time Frame
    From baseline to 12 weeks from the start of drug after crossover
Full study description
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.
Source references
references
  1. 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.
    pmid
    22354624
    type
    RESULT
  2. 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.
    pmid
    21235716
    type
    RESULT
  3. 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.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      source title
      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Not medical advice