Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057759

Purpose

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	Intervention
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity Sexual Dysfunction and Infertility Sexuality	Drug: sildenafil citrate

Study Type:	Interventional
Study Design:	Allocation: Randomized 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Erectile Dysfunction Infertility Prostate Cancer

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 2003

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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., diethylstibestrol) 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057759

Show 30 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Deborah Watkins Bruner, RN, PhD

Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 Jan 14; [Epub ahead of print]

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.

ClinicalTrials.gov Identifier:	NCT00057759 History of Changes
Obsolete Identifiers:	NCT00075127
Other Study ID Numbers:	CDR0000269135, RTOG-0215, NCI-P-02-0234
Study First Received:	April 7, 2003
Last Updated:	February 18, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

sexual dysfunction and infertility
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:

Infertility
Prostatic Neoplasms
Erectile Dysfunction
Radiation Injuries
Genital Diseases, Male
Genital Diseases, Female
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological

Sexual and Gender Disorders
Mental Disorders
Wounds and Injuries
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012