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

18 Years
Not Enrolling
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity, Sexual Dysfunction, Sexuality and Reproductive Issues

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Trial Information

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


- 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

- 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 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

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No myocardial infarction within the past year


- 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


Biologic therapy

- Not specified


- 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.,
diethylstibestrol) agents


- See Disease Characteristics


- No prior penile implant

- No prior bilateral orchiectomy


- No concurrent sildenafil

- No concurrent participation in another medical research study to treat prostate

- No concurrent organic nitrate or requirement for nitrates (e.g., nitroglycerin as

- No concurrent ketoconazole, itraconazole, or erythromycin

- No concurrent use of mechanical (vacuum) devices or intracorporeal, intraurethral,
topical, or oral agents for erectile dysfunction

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Deborah Watkins Bruner, RN, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

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



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