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Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sildenafil citrate
Placebo
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Diablo Regional Cancer Center
  • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
  • John Muir/Mt. Diablo Comprehensive Cancer Center
  • Cape Cod Hospital
  • University of Michigan Comprehensive Cancer Center
  • West Michigan Cancer Center
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Washoe Cancer Services at Washoe Medical Center - Reno
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Fox Chase Virtua Health Cancer Program - Marlton
  • Community Regional Cancer Center at Community Medical Center
  • Roswell Park Cancer Institute
  • CCOP - North Shore University Hospital
  • Akron City Hospital
  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
  • Cancer Treatment Center
  • LaFortune Cancer Center at St. John Medical Center
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Bryn Mawr Hospital
  • Paoli Memorial Hospital
  • Albert Einstein Cancer Center
  • CCOP - MainLine Health
  • Lankenau Cancer Center at Lankenau Hospital
  • LDS Hospital
  • Naval Medical Center - Portsmouth
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • Community Memorial Hospital
  • Medical College of Wisconsin Cancer Center
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sildenafil citrate

Placebo

Arm Description

Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.

Placebo with similar "dose escalation" opportunity for 12 weeks.

Outcomes

Primary Outcome Measures

Ability to obtain an erection, as measured by question 1 on the IIEF

Secondary Outcome Measures

Overall sexual function and satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)
Partner sexual satisfaction as measured by the SAQ-Partner
Patient and spouse marital adjustment as measured by the Locke's Marital Adjustment Test
Predictors of erectile dysfunction therapy

Full Information

First Posted
April 7, 2003
Last Updated
November 14, 2015
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00057759
Brief Title
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Official Title
Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity, Sexual Dysfunction, Sexuality and Reproductive Issues
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil citrate
Arm Type
Experimental
Arm Description
Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo with similar "dose escalation" opportunity for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Partner sexual satisfaction as measured by the SAQ-Partner
Time Frame
From baseline to 12 weeks from the start of drug after crossover
Title
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
Title
Predictors of erectile dysfunction therapy
Time Frame
From baseline to 12 weeks from the start of drug after crossover

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Watkins Bruner, RN, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Diablo Regional Cancer Center
City
Concord
State/Province
California
ZIP/Postal Code
94524-4110
Country
United States
Facility Name
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
John Muir/Mt. Diablo Comprehensive Cancer Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Cape Cod Hospital
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Washoe Cancer Services at Washoe Medical Center - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program - Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Community Regional Cancer Center at Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
LaFortune Cancer Center at St. John Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Naval Medical Center - Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708-2197
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Community Memorial Hospital
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22354624
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.
Results Reference
result
PubMed Identifier
21235716
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.
Results Reference
result
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.
Results Reference
result

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Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

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