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

January 18, 2018 updated by: Radiation Therapy Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

242

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - BCCA-Cancer Centre for the Southern Interior
  - Surrey, British Columbia, Canada, V3V 1Z2
    - BCCA-Fraser Valley Cancer Centre
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - BCCA-Vancouver Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Juravinski Cancer Centre at Hamilton Health Sciences
  - London, Ontario, Canada, N6A 4L6
    - London Regional Cancer Program
- Quebec
  - Quebec City, Quebec, Canada, G1R 2J6
    - CHUQ - Pavilion Hotel-Dieu de Quebec
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - University of Alabama at Birmingham
  - Mobile, Alabama, United States, 36608
    - Providence Hospital
- Arizona
  - Peoria, Arizona, United States, 85381
    - Arizona Center for Cancer Care-Peoria
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic in Arizona
  - Scottsdale, Arizona, United States, 85260
    - Arizona Oncology Services Foundation
  - Tucson, Arizona, United States, 85704
    - Arizona Oncology Associates-West Orange Grove
- California
  - Auburn, California, United States, 95603
    - Sutter Cancer Centers Radiation Oncology Services-Auburn
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Cameron Park, California, United States, 95682
    - Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  - Carmichael, California, United States, 95608
    - Mercy San Juan Medical Center
  - Chico, California, United States, 95926
    - Enloe Medical Center
  - Fresno, California, United States, 93720
    - Saint Agnes Medical Center
  - Long Beach, California, United States, 90822
    - Veterans Administration Long Beach Medical Center
  - Northridge, California, United States, 91325
    - Northridge Hospital Medical Center
  - Oakland, California, United States, 94611
    - Kaiser Permanente Oakland-Broadway
  - Roseville, California, United States, 95661
    - Sutter Cancer Centers Radiation Oncology Services-Roseville
  - Sacramento, California, United States, 95819
    - Mercy General Hospital Radiation Oncology Center
  - Sacramento, California, United States, 95815
    - Radiological Associates of Sacramento
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center
  - San Francisco, California, United States, 94115
    - UCSF-Mount Zion
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Cancer Treatment Center
  - Vacaville, California, United States, 95687
    - Sutter Cancer Centers Radiation Oncology Services-Vacaville
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center - Anschutz Cancer Pavilion
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
- Connecticut
  - New Britain, Connecticut, United States, 06050
    - The Hospital of Central Connecticut
- Delaware
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Washington Hospital Center
- Florida
  - Deerfield Beach, Florida, United States, 33064
    - Broward Health North
  - Gainesville, Florida, United States, 32610
    - University of Florida
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Jacksonville, Florida, United States, 32207
    - Baptist Cancer Institute
  - Jacksonville, Florida, United States, 32209
    - University of Florida Health Science Center
  - Jacksonville, Florida, United States, 32207
    - Cancer Specialists of North Florida-Southside
  - Jacksonville, Florida, United States, 32258
    - Cancer Specialists of North Florida-Baptist South
  - Jacksonville Beach, Florida, United States, 32250
    - Cancer Specialists of North Florida-Beaches
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Orange Park, Florida, United States, 32073
    - 21st Century Oncology-Orange Park
  - Palatka, Florida, United States, 32177
    - 21st Century Oncology-Palatka
  - Saint Augustine, Florida, United States, 32086
    - Cancer Specialists of North Florida-Saint Augustine
- Georgia
  - Columbus, Georgia, United States, 31904
    - John B Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Atlanta VA Medical Center
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
- Illinois
  - Chicago, Illinois, United States, 60657
    - Advocate Illinois Masonic Medical Center
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital.
  - Springfield, Illinois, United States, 62702
    - Saint John's Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
- Indiana
  - Anderson, Indiana, United States, 46016
    - Saint Vincent Anderson Regional Hospital/Cancer Center
  - Bloomington, Indiana, United States, 47403
    - IU Health Bloomington
  - Fort Wayne, Indiana, United States, 46805
    - Parkview Hospital Randallia
  - Fort Wayne, Indiana, United States, 46804
    - Radiation Oncology Associates PC
  - Goshen, Indiana, United States, 46526
    - IU Health Goshen Center for Cancer Care
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Baptist Health Lexington
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic CCOP
- Maine
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center
  - Scarborough, Maine, United States, 04074
    - Maine Medical Center- Scarborough Campus
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Baltimore, Maryland, United States, 21229
    - Saint Agnes Hospital
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
  - Columbia, Maryland, United States, 21044
    - Central Maryland Radiation Oncology in Howard County
  - Glen Burnie, Maryland, United States, 21061
    - Tate Cancer Center
- Massachusetts
  - Fall River, Massachusetts, United States, 02721
    - Saint Anne's Hospital
  - Hyannis, Massachusetts, United States, 02601
    - Cape Cod Hospital
- Michigan
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Commerce, Michigan, United States, 48382
    - Huron Valley-Sinai Hospital
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Flint, Michigan, United States, 48532
    - McLaren-Flint
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - Saint Luke's Hospital of Duluth
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63141
    - Barnes-Jewish West County Hospital
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center - Saint Peters
- Nebraska
  - Kearney, Nebraska, United States, 68847
    - Good Samaritan Hospital
  - Lincoln, Nebraska, United States, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - Concord Hospital
  - Dover, New Hampshire, United States, 03820
    - Wentworth-Douglass Hospital
  - Exeter, New Hampshire, United States, 03833
    - Exeter Hospital
  - Manchester, New Hampshire, United States, 03103
    - Elliot Hospital
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Voorhees, New Jersey, United States, 08043
    - MD Anderson Cancer Center at Cooper-Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Cancer Center
  - Las Cruces, New Mexico, United States, 88011
    - Memorial Medical Center - Las Cruces
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology PC - Albany
  - Bay Shore, New York, United States, 11706
    - Southside Hospital
  - Binghamton, New York, United States, 13905
    - Lourdes Hospital
  - Brooklyn, New York, United States, 11209
    - Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - New Hyde Park, New York, United States, 11040
    - Long Island Jewish Medical Center
  - New York, New York, United States, 10032
    - Columbia University Medical Center
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Mission Hospital-Memorial Campus
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - High Point, North Carolina, United States, 27261
    - High Point Regional Hospital
  - Morehead City, North Carolina, United States, 28557
    - The Coleman Radiation Center-Carteret General Hospital
  - New Bern, North Carolina, United States, 28560
    - CarolinaEast Health System-Medical Center
  - Supply, North Carolina, United States, 28462
    - South Atlantic Radiation Oncology
  - Wilmington, North Carolina, United States, 28401
    - Coastal Carolina Radiation Oncology
  - Wilmington, North Carolina, United States, 28401
    - New Hanover Regional Medical Center
- Ohio
  - Akron, Ohio, United States, 44304
    - Summa Akron City Hospital/Cooper Cancer Center
  - Barberton, Ohio, United States, 44203
    - Summa Barberton Hospital
  - Cincinnati, Ohio, United States, 45267
    - University of Cincinnati
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Medical Center
  - Columbus, Ohio, United States, 43210
    - Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  - Independence, Ohio, United States, 44131
    - Cleveland Clinic Cancer Center Independence
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mentor, Ohio, United States, 44060
    - Lake University Ireland Cancer Center
  - Middleburg Heights, Ohio, United States, 44130
    - Southwest General Health Center Ireland Cancer Center
  - Orange Village, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Salem, Ohio, United States, 44460
    - Cancer Care Center, Incorporated
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Westlake, Ohio, United States, 44145
    - UHHS-Westlake Medical Center
  - Wooster, Ohio, United States, 44691
    - Cancer Treatment Center
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic Wooster Specialty Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Eugene, Oregon, United States, 97401
    - Willamette Valley Cancer Center
  - Grants Pass, Oregon, United States, 97527
    - Three Rivers Community Hospital
  - Medford, Oregon, United States, 97504
    - Providence Medford Medical Center
  - Medford, Oregon, United States, 97504
    - Rogue Valley Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Portland, Oregon, United States, 97213
    - Western Oncology Research Consortium
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Abington Memorial Hospital
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Memorial Hospital
  - Furlong, Pennsylvania, United States, 18925
    - Fox Chase Cancer Center Buckingham
  - Gettysburg, Pennsylvania, United States, 17325
    - Adams Cancer Center
  - Hanover, Pennsylvania, United States, 17331
    - Cherry Tree Cancer Center
  - King Of Prussia, Pennsylvania, United States, 19406
    - Academic Urology Prostate Center
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Medical Center
  - York, Pennsylvania, United States, 17405
    - WellSpan Health-York Hospital
- South Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
- Texas
  - Denton, Texas, United States, 76210
    - Texas Oncology-Denton South
  - Fort Worth, Texas, United States, 76104
    - The Klabzuba Cancer Center
  - Galveston, Texas, United States, 77555-0565
    - University of Texas Medical Branch at Galveston
  - Odessa, Texas, United States, 79761
    - West Texas Cancer Center
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Science Center
  - Sherman, Texas, United States, 75090
    - Texas Cancer Center-Sherman
  - Sugar Land, Texas, United States, 77479
    - Texas Oncology Cancer Center Sugar Land
  - Tyler, Texas, United States, 75702
    - Tyler Cancer Center
- Utah
  - Murray, Utah, United States, 84157
    - Intermountain Medical Center
  - Provo, Utah, United States, 84604-3337
    - Utah Valley Regional Medical Center
  - Saint George, Utah, United States, 84770
    - Dixie Medical Center Regional Cancer Center
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists-Salt Lake City
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
- Washington
  - Seattle, Washington, United States, 98101
    - Virginia Mason CCOP
  - Vancouver, Washington, United States, 98684
    - Compass Oncology Vancouver
- Wisconsin
  - Appleton, Wisconsin, United States, 54911
    - Appleton Medical Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Mayo Clinic Health System-Franciscan Healthcare
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53295
    - Clement J. Zablocki VA Medical Center
  - Oconomowoc, Wisconsin, United States, 53066-3896
    - Oconomowoc Memorial Hospital-ProHealth Care Inc
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Door County Cancer Center
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital - ProHealth Care
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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
- 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.

Exclusion Criteria:

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
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Experimental: Tadalafil	Drug: Tadalafil Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline and 30 weeks from the start of radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT Time Frame: Baseline, 1 and 2 years from the start of tadalafil or placebo	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.	Baseline, 1 and 2 years from the start of tadalafil or placebo
Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF) Time Frame: Baseline, week 30, and years 1 and 2 from start of treatment	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.	Baseline, week 30, and years 1 and 2 from start of treatment
Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score Time Frame: Baseline, week 30 and years 1 and 2 after the start of treatment	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.	Baseline, week 30 and years 1 and 2 after the start of treatment
Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score Time Frame: Baseline, week 30 and years 1 and 2 after the start of treatment	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.	Baseline, week 30 and years 1 and 2 after the start of treatment
Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test Time Frame: Baseline, week 30 and years 1 and 2 after the start of treatment	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.	Baseline, week 30 and years 1 and 2 after the start of treatment
Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test Time Frame: Baseline, week 30 and years 1 and 2 after the start of treatment	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.	Baseline, week 30 and years 1 and 2 after the start of treatment

Other Outcome Measures

Outcome Measure	Time Frame
Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT Time Frame: Baseline, week 30 and years 1 and 2 after the start of treatment	Baseline, week 30 and years 1 and 2 after the start of treatment
Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT Time Frame: Baseline, week 30 and years 1 and 2 after the start of treatment	Baseline, week 30 and years 1 and 2 after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

NRG Oncology

Investigators

Principal Investigator: Deborah Watkins Bruner, RN, PhD, Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RTOG 0831
CDR0000647146
NCI-2011-01934 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers