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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


N/A
18 Years
N/A
Not Enrolling
Male
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


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.

Inclusion 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

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000269135

NCT ID:

NCT00057759

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

Name

Location

Akron City HospitalAkron, Ohio  44304
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
CCOP - North Shore University HospitalManhasset, New York  11030
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Cape Cod HospitalHyannis, Massachusetts  02601
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
LDS HospitalSalt Lake City, Utah  84143
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Mount Diablo Regional Cancer CenterConcord, California  94524-4110
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
LaFortune Cancer Center at St. John Medical CenterTulsa, Oklahoma  74104
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Washoe Cancer Services at Washoe Medical Center - RenoReno, Nevada  89502
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial HospitalInglewood, California  90301
Community Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755