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Prostate CancerNCT00057759

Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

A study testing sildenafil citrate in people with Prostate Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Radiation Therapy Oncology Group at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
sildenafil citrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
30 sitesUnited States
Study dates
Jan 2003to Dec 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Mount Diablo Regional Cancer Center

    Concord, California, 94524-4110

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital

    Inglewood, California, 90301

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Fox Chase Virtua Health Cancer Program - Marlton

    Marlton, New Jersey, 08053

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Washoe Cancer Services at Washoe Medical Center - Reno

    Reno, Nevada, 89502

  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

    Salem, Ohio, 44460

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Community Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • LaFortune Cancer Center at St. John Medical Center

    Tulsa, Oklahoma, 74104

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • John Muir/Mt. Diablo Comprehensive Cancer Center

    Walnut Creek, California, 94598

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
sildenafil citrate, Placebo
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
Medical subject headings
Prostatic Neoplasms, Radiation Injuries, Sexual Dysfunction, Physiological, Sexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sildenafil citrateDrug

  • PlaceboOther

    Placebo

Study groups in NCT00057759
Study groupRoleWhat they receive
Sildenafil citrateExperimentalSildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
Receives: Drug: sildenafil citrate
PlaceboPlacebo comparatorPlacebo with similar "dose escalation" opportunity for 12 weeks.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From baseline to 12 weeks from the start of drug after crossover

Secondary outcomes (4)

  1. Overall sexual function and satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)

    Measured: From baseline to 12 weeks from the start of drug after crossover

  2. Partner sexual satisfaction as measured by the SAQ-Partner

    Measured: 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

    Measured: From baseline to 12 weeks from the start of drug after crossover

  4. Predictors of erectile dysfunction therapy

    Measured: From baseline to 12 weeks from the start of drug after crossover

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057759
Sponsor's protocol ID
RTOG-0215
Other IDs
CDR0000269135, NCI-P-02-0234
Status last verified
Nov 2015
First submitted
7 Apr 2003
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22354624

  • 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.

    PubMed 21235716

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing sildenafil citrate in people with Prostate Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Radiation Therapy Oncology Group at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00057759, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.

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