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AzTrials

Prostate CancerPhase 3NCT00931528

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

A Phase 3 study testing Tadalafil in people with Prostate Cancer and Sexual Dysfunction, run by Radiation Therapy Oncology Group at 192 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is more effective than a placebo in preventing erectile dysfunction. Read more about this study

Who is it for?
Ages 18 to 120 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer, Sexual Dysfunction
What is being tested?
Tadalafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
192 sitesin 2 countries
Study dates
Nov 2009to Nov 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Clinical stage T1b-T2b (AJCC, 6th ed.) adenocarcinoma of the prostate within 6 months of registration
  • Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), nodal sampling, or dissection within 3 months prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm. Lymph node assessment is optional, and at investigator discretion, for patients with Gleason Score <7.
  • No evidence of bone metastases (M0) on bone scan within 3 months prior to registration. Equivocal bone scan findings are allowed if plain films are negative for metastasis. Bone metastases assessment is optional, and at investigator discretion, for patients with Gleason Score <7.
  • Baseline serum prostatic specific antigen (PSA) value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 3 months prior to registration.
  • -4.1 Any of the following combinations of factors (NOTE: tumor found in 1 or both lobes on biopsy, but not palpable, will not alter T stage):
  • T1b-T2b disease, Gleason Score <7 and serum total PSA that is <20 ng/ml or
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  • T1b-T2b disease, Gleason Score ≥7 and PSA that is <15 ng/ml
  • Serum total testosterone level prior to the initiation of radiation therapy (RT) within normal range according to institutional guidelines
  • Zubrod Performance Status 0 or 1 (Appendix III)
  • Age ≥ 18 years
  • Treatment that will consist of either external beam RT alone to the prostate ± seminal vesicles only at a dose between 75 Gy and 79.2 Gy or brachytherapy alone (NOTE: treatment with combined external RT and brachytherapy excludes patient participation)
  • Pretreatment (before starting prostate cancer treatment) erectile function as measured by IIEF Question 1, "How often were you able to get an erection during sexual activity?" - with responses of:
  • "sometimes (about half the time)" [response 3] or
  • "most times (much more than half the time)" [response 4] or
  • "almost always/always" [response 5]
  • History of prior tadalafil use: Document usual dosage per sexual encounter, date of last dose, and patient's response (No; Yes-Unsatisfactory Response; Yes-Satisfactory Response). Regardless of past experience, the patient is eligible if he agrees to adhere to protocol and take only tadalafil or placebo prescribed on study.
  • Although patients with partners are targeted for recruitment, patients without partners or without partners willing to participate are eligible. Patients (and spouses/partners, if willing to participate) must be able to provide study-specific informed consent.

Who cannot join

  • The patient's participation in another medical research study that involves the treatment of ED
  • Previous or concomitant invasive cancer (American Joint Committee on Cancer [AJCC] Stage >0), other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), or a hematological malignancy (e.g., leukemia, lymphoma, myeloma) unless continually disease free for at least 5 years
  • History of myocardial infarction within the last year
  • Heart failure in the last 6 months
  • Uncontrolled arrhythmias, hypotension (<90/50mm Hg), or uncontrolled hypertension (>170/100 mm Hg)
  • Stroke within the last 6 months
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  • Use of luteinizing hormone-releasing hormone (LHRH) agonist androgen suppression (e.g., Lupron, Zoladex), anti-androgen (e.g., Casodex, Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within the last 6 months
  • Current use of any organic nitrate or as needed nitrates (e.g., use of nitroglycerin)
  • Current use of cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir
  • Known moderate to severe renal insufficiency or end-stage renal disease
  • Known severe hepatic impairment
  • Use of mechanical (vacuum) devices, intracorporeal, intraurethral, topical, or oral (sildenafil, tadalafil, vardenafil) agents as therapy for ED or supplements to enhance sexual function within 5-7 days prior to the start of RT. Patients who discontinue these therapies remain eligible if they can meet eligibility criteria
  • Pretreatment (before starting prostate cancer treatment) ED as measured by IIEF Question 1, "How often were you able to get an erection during sexual activity?" - with responses of:
  • "no sexual activity" [response 0] or
  • "almost never/never" [response 1] or
  • "a few times (much less than half the time)" [response 2]
  • Prior penile implant or history of bilateral orchiectomy
  • Prior prostatectomy, prostatic cryosurgery or high-intensity focused ultrasound (HIFU), radionuclide prostate brachytherapy, or chemotherapy for prostate cancer
  • Prior or anticipated combined external RT and brachytherapy
  • Prior or anticipated external RT to the pelvic ± para-aortic lymph nodes
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
  • Anatomical genital abnormalities or concurrent conditions that in the estimation of the physician would prohibit sexual intercourse or prevent study completion
  • Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up

Trial locations and contacts

192 sites in 2 countries.

192 sites in 2 countries

United States183 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • New York Oncology Hematology PC - Albany

    Albany, New York, 12206

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • Appleton Medical Center

    Appleton, Wisconsin, 54911

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Southside Hospital

    Bay Shore, New York, 11706

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Lourdes Hospital

    Binghamton, New York, 13905

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • IU Health Bloomington

    Bloomington, Indiana, 47403

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus

    Brooklyn, New York, 11209

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Medical Center

    Chico, California, 95926

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Siteman Cancer Center - Saint Peters

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Huron Valley-Sinai Hospital

    Commerce, Michigan, 48382

  • Concord Hospital

    Concord, New Hampshire, 03301

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Broward Health North

    Deerfield Beach, Florida, 33064

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • McLaren-Flint

    Flint, Michigan, 48532

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • The Klabzuba Cancer Center

    Fort Worth, Texas, 76104

  • Saint Agnes Medical Center

    Fresno, California, 93720

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

  • University of Florida

    Gainesville, Florida, 32610

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555-0565

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • IU Health Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Cancer Specialists of North Florida-Southside

    Jacksonville, Florida, 32207

  • University of Florida Health Science Center

    Jacksonville, Florida, 32209

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Cancer Specialists of North Florida-Baptist South

    Jacksonville, Florida, 32258

  • Cancer Specialists of North Florida-Beaches

    Jacksonville Beach, Florida, 32250

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Good Samaritan Hospital

    Kearney, Nebraska, 68847

  • Academic Urology Prostate Center

    King of Prussia, Pennsylvania, 19406

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Memorial Medical Center - Las Cruces

    Las Cruces, New Mexico, 88011

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Veterans Administration Long Beach Medical Center

    Long Beach, California, 90822

  • Elliot Hospital

    Manchester, New Hampshire, 03103

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Providence Medford Medical Center

    Medford, Oregon, 97504

  • Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Southwest General Health Center Ireland Cancer Center

    Middleburg Heights, Ohio, 44130

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Clement J. Zablocki VA Medical Center

    Milwaukee, Wisconsin, 53295

  • Providence Hospital

    Mobile, Alabama, 36608

  • The Coleman Radiation Center-Carteret General Hospital

    Morehead City, North Carolina, 28557

  • Intermountain Medical Center

    Murray, Utah, 84157

  • CarolinaEast Health System-Medical Center

    New Bern, North Carolina, 28560

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Ochsner Clinic CCOP

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Northridge Hospital Medical Center

    Northridge, California, 91325

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Wisconsin, 53066-3896

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • UHHS-Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • 21st Century Oncology-Orange Park

    Orange Park, Florida, 32073

  • 21st Century Oncology-Palatka

    Palatka, Florida, 32177

  • Advocate Lutheran General Hospital.

    Park Ridge, Illinois, 60068

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Western Oncology Research Consortium

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604-3337

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Radiological Associates of Sacramento

    Sacramento, California, 95815

  • Mercy General Hospital Radiation Oncology Center

    Sacramento, California, 95819

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Cancer Specialists of North Florida-Saint Augustine

    Saint Augustine, Florida, 32086

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center

    San Antonio, Texas, 78229

  • UCSF-Mount Zion

    San Francisco, California, 94115

  • California Pacific Medical Center

    San Francisco, California, 94118

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Maine Medical Center- Scarborough Campus

    Scarborough, Maine, 04074

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona, 85260

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Saint John's Hospital

    Springfield, Illinois, 62702

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Door County Cancer Center

    Sturgeon Bay, Wisconsin, 54235-1495

  • Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • South Atlantic Radiation Oncology

    Supply, North Carolina, 28462

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Arizona Oncology Associates-West Orange Grove

    Tucson, Arizona, 85704

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Sutter Cancer Centers Radiation Oncology Services-Vacaville

    Vacaville, California, 95687

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Compass Oncology Vancouver

    Vancouver, Washington, 98684

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Waukesha Memorial Hospital - ProHealth Care

    Waukesha, Wisconsin, 53188

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Coastal Carolina Radiation Oncology

    Wilmington, North Carolina, 28401

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Cleveland Clinic Wooster Specialty Center

    Wooster, Ohio, 44691

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17405

Other trials in United States

Canada9 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA-Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUQ - Pavilion Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • BCCA-Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated With Radiotherapy for Prostate Cancer

RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is more effective than a placebo in preventing erectile dysfunction.

PURPOSE: This randomized phase III trial is studying tadalafil to see how well it works compared with a placebo in preventing erectile dysfunction in patients with prostate cancer treated with radiation therapy.

Read the detailed description

OBJECTIVES:

Primary

  • To determine whether tadalafil maintains spontaneous (off-drug) erectile function, as measured by the International Index of Erectile Function (IIEF) as compared to placebo at weeks 28-30 after initiation of radiotherapy in patients with prostate cancer.

Secondary

  • Determine the difference in spontaneous (off-drug) erectile function between tadalafil and placebo at 1 and 2 years.
  • Determine the difference in overall sexual function as measured by the IIEF between tadalafil and placebo at weeks 28-30 and at 1 and 2 years.
  • Determine differences in patient and partner overall sexual satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ) between tadalafil and placebo at weeks 28-30 and at 1 and 2 years.
  • Determine differences in patient and partner marital adjustment as measured by Locke's Marital Adjustment Test (LMAT) between tadalafil and placebo at weeks 28-30 and at 1 and 2 years.
  • Determine associations between patient and partner overall sexual satisfaction as measured by SAQ and patient and partner marital adjustment as measured by LMAT at weeks 28-30 and at 1 and 2 years.
  • Determine patient-related factors (i.e., age, pretreatment sexual response, tobacco use, and comorbidities) that may predict response to tadalafil therapy at weeks 28-30 and at 1 and 2 years.
  • Determine the difference in adverse events between tadalafil and placebo as assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 criteria.

Tertiary

  • Characterization of preference and erectile function among patients who choose to stay on (or if on placebo, to start) tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor other than tadalafil, a non-PDE5-inhibitor erectile aide, or no PDE5 inhibitor or erectile aide at 28-30 weeks and at 1 and 2 years.
  • Identification of radiotherapy factors (i.e., modality, prescribed total dose, planning target volume margin, penile bulb dose-volume parameters) associated with erectile function.
  • Evaluation of the number of patients screened for eligibility, the number eligible that are presented the study, the number who refuse, and the number who are accrued.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 65 years vs > 65 years) and radiotherapy treatment (external beam radiation therapy vs brachytherapy*). Patients are randomized to 1 of 2 treatment arms.

Note: * Radiotherapy start date for brachytherapy patients is the date of the procedure.

All patients undergo either external beam radiotherapy alone to the prostate ± seminal vesicles only or low-dose rate permanent brachytherapy alone.

  • Arm I: Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete the International Index of Erectile Function (IIEF), the Sexual Adjustment Questionnaire (SAQ), the Locke's Marital Adjustment Test (LMAT) (if applicable), and the Expanded Prostate Cancer Index Composite Sexual Medications and Devices Evaluations Supplement questionnaires periodically. Partners or spouses complete the SAQ-Partner, LMAT (if applicable), and IIEF questionnaires periodically.

After completion of study treatment, patients are followed at 28-30 weeks, and annually for up to 2 years.

Being tested
Tadalafil, Placebo
Keywords
sexual dysfunction, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms, Sexual Dysfunction, Physiological

What participants receive

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

  • TadalafilDrug

    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.

  • PlaceboOther

    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.

Study groups in NCT00931528
Study groupRoleWhat they receive
TadalafilExperimentalTadalafil
Receives: Drug: Tadalafil
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

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

  1. Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)

    EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.

    Measured: Baseline and 30 weeks from the start of radiation therapy

Secondary outcomes (6)

  1. Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT

    The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.

    Measured: Baseline, 1 and 2 years from the start of tadalafil or placebo

  2. Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)

    The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.

    Measured: Baseline, week 30, and years 1 and 2 from start of treatment

  3. Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score

    The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.

    Measured: Baseline, week 30 and years 1 and 2 after the start of treatment

  4. Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score

    The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.

    Measured: Baseline, week 30 and years 1 and 2 after the start of treatment

  5. Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test

    The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.

    Measured: Baseline, week 30 and years 1 and 2 after the start of treatment

  6. Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test

    The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.

    Measured: Baseline, week 30 and years 1 and 2 after the start of treatment

Timeline

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

  1. First posted2 Jul 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2012
  4. Study completionNov 2014

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931528
Sponsor's protocol ID
RTOG 0831
Other IDs
CDR0000647146, NCI-2011-01934
Status last verified
Jan 2018
First submitted
30 Jun 2009
Last updated
14 Feb 2018
Data monitoring committee
Yes

Publications

  • Pisansky TM, Pugh SL, Greenberg RE, Pervez N, Reed DR, Rosenthal SA, Mowat RB, Raben A, Buyyounouski MK, Kachnic LA, Bruner DW. Tadalafil for prevention of erectile dysfunction after radiotherapy for prostate cancer: the Radiation Therapy Oncology Group [0831] randomized clinical trial. JAMA. 2014 Apr 2;311(13):1300-7. doi: 10.1001/jama.2014.2626.

    PubMed 24691606

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil in people with Prostate Cancer and Sexual Dysfunction, run by Radiation Therapy Oncology Group at 192 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States, Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT) (time frame: Baseline and 30 weeks from the start of radiation therapy). 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 NCT00931528, which also lists 1 linked publication.

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 14 Feb 2018.

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