Clincosm LogoSign in Get a demo

Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00057759
Collaborator
National Cancer Institute (NCI) (NIH)
115
Enrollment
30
Locations
2
Arms
3.8
Patients Per Site

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: sildenafil citrate
  • Other: Placebo
 N/A

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

Study Type:
Interventional
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 :
Jan 1, 2003
Actual Primary Completion Date :
Dec 1, 2006

Arms and Interventions

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

Primary Outcome Measures

  1. Ability to obtain an erection, as measured by question 1 on the IIEF [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) [From baseline to 12 weeks from the start of drug after crossover]

  2. Partner sexual satisfaction as measured by the SAQ-Partner [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 [From baseline to 12 weeks from the start of drug after crossover]

  4. Predictors of erectile dysfunction therapy [From baseline to 12 weeks from the start of drug after crossover]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mount Diablo Regional Cancer Center Concord California United States 94524-4110
2 Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital Inglewood California United States 90301
3 John Muir/Mt. Diablo Comprehensive Cancer Center Walnut Creek California United States 94598
4 Cape Cod Hospital Hyannis Massachusetts United States 02601
5 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0942
6 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
7 St. John's Regional Health Center Springfield Missouri United States 65804
8 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
9 Washoe Cancer Services at Washoe Medical Center - Reno Reno Nevada United States 89502
10 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
11 Fox Chase Virtua Health Cancer Program - Marlton Marlton New Jersey United States 08053
12 Community Regional Cancer Center at Community Medical Center Toms River New Jersey United States 08755
13 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
14 CCOP - North Shore University Hospital Manhasset New York United States 11030
15 Akron City Hospital Akron Ohio United States 44309-2090
16 Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem Ohio United States 44460
17 Cancer Treatment Center Wooster Ohio United States 44691
18 LaFortune Cancer Center at St. John Medical Center Tulsa Oklahoma United States 74104
19 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
20 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
21 Paoli Memorial Hospital Paoli Pennsylvania United States 19301-1792
22 Albert Einstein Cancer Center Philadelphia Pennsylvania United States 19141
23 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
24 Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania United States 19096
25 LDS Hospital Salt Lake City Utah United States 84143
26 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
27 Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
28 Community Memorial Hospital Menomonee Falls Wisconsin United States 53051
29 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226
30 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295

Sponsors and Collaborators

  • Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Deborah Watkins Bruner, RN, PhD, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00057759
Other Study ID Numbers:
  • RTOG-0215
  • CDR0000269135
  • NCI-P-02-0234
  • NCT00075127
First Posted:
Apr 9, 2003
Last Update Posted:
Nov 17, 2015
Last Verified:
Nov 1, 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:
Prostatic Neoplasms
Erectile Dysfunction
Sildenafil Citrate

Study Results

No Results Posted as of Nov 17, 2015