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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00931528
First received: June 30, 2009
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

RATIONALE: Tadalafil may help prevent erectile dysfunction 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.


Condition Intervention Phase
Prostate Cancer
Sexual Dysfunction
Drug: tadalafil
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Spontaneous (off-drug) erectile function (EF) as measured by International Index of Erectile Function (IIEF) at weeks 28-30 after initiation of radiation therapy (RT) [ Time Frame: Baseline to 30 weeks from the start of radiation therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spontaneous (off-drug) EF at years 1 and 2 after initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Overall sexual function as measured by the IIEF at weeks 28-30 and years 1 and 2 after initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient and partner overall sexual satisfaction as measured by SAQ at weeks 28-30 and years 1 and 2 after initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient and partner marital adjustment as measured by the Locke's Marital Adjustment Test at weeks 28-30 and years 1 and 2 after initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient-related predictors of EF at weeks 28-30 and years 1 and 2 after initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient follow-up treatment for erectile dysfunction at weeks 28-30 and years 1 and 2 after initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Radiotherapy factors associated with spontaneous (off-drug) EF at weeks 28-30 and years 1 and 2 after initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: November 2009
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
Drug: tadalafil
Given orally
Placebo Comparator: Arm II
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Other: placebo
Given orally

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosis of adenocarcinoma of the prostate within the past 6 months

      • Clinical stage T1b-T2b
      • No distant metastases
      • Clinically negative lymph nodes established by imaging (pelvic ± abdominal CT or MRI), nodal sampling, or dissection within the past 3 months

        • Patients with lymph nodes equivocal or questionable by imaging are eligible provided the nodes are ≤ 1.5 cm
        • Lymph node assessment is optional and at the investigator's discretion for patients with Gleason score < 7
      • No evidence of bone metastases on bone scan within the past 3 months

        • Equivocal bone scan findings allowed provided plain films are negative for metastasis
        • Bone metastasis assessment is optional and at the investigator's discretion for patients with Gleason score < 7
      • Baseline serum prostate-specific antigen (PSA) value performed with an FDA-approved assay within the past 3 months and meets 1 of the following criteria:

        • Gleason score < 7 and PSA < 20 ng/mL
        • Gleason score ≥ 7 and PSA < 15 ng/mL
      • Planning to undergo treatment with either external radiotherapy alone to the prostate ± seminal vesicals only at a dose of 75-79.2 Gy OR brachytherapy alone
      • Pretreatment erectile function as measured by International Index of Erectile Function questionnaire response 3, 4, or 5 on question 1
    • Spouse or partner of these patients (optional)

      • Male or female

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Serum total testosterone level normal prior to the initiation of radiotherapy
  • No myocardial infarction within the past year
  • No heart failure within the past 6 months
  • No stroke within the past 6 months
  • No uncontrolled arrhythmias, hypotension (BP < 90/50 mm Hg), or uncontrolled hypertension (BP > 170/100 mm Hg)
  • No known moderate to severe renal insufficiency or end-stage renal disease
  • No known severe hepatic impairment
  • No prior or concurrent invasive cancer (stage > 0) except for localized basal cell or squamous cell skin carcinoma (stage 0-II), or a hematological malignancy (e.g., leukemia, lymphoma, myeloma) unless disease-free ≥ 5 years
  • No known AIDS based upon current Centers for Disease Control (CDC) definition
  • No anatomical genital abnormalities or concurrent conditions that, in the estimation of the physician, would prohibit sexual intercourse or prevent study completion
  • No major medical or psychiatric illness that, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior tadalafil allowed
  • No prior penile implant or history of bilateral orchiectomy
  • No prior prostatectomy, prostatic cryosurgery, high-intensity focused ultrasound, radionuclide prostate brachytherapy, or chemotherapy for prostate cancer
  • No prior or anticipated combined external radiotherapy and brachytherapy
  • No prior or anticipated external radiotherapy to the pelvic ± para-aortic lymph nodes
  • More than 6 months since prior leuteinizing hormone-releasing hormone agonist androgen suppression (e.g., leuprolide acetate, goserelin), antiandrogen (e.g., flutamide, bicalutamide, or nilutamide), or estrogenic (e.g., diethylstilbestrol) agents
  • At least 5-7 days since prior use of mechanical (vacuum) devices, intracorporeal, intraurethral, topical, or oral (sildenafil, tadalafil, vardenafil) agents as therapy for erectile dysfunction (ED) or supplements to enhance sexual function
  • No other concurrent medical research study that involves the treatment of ED
  • No concurrent use of any organic nitrate or as-needed nitrates (e.g., use of nitroglycerin)
  • No concurrent cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931528

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

Additional Information:
No publications provided by Radiation Therapy Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00931528     History of Changes
Other Study ID Numbers: RTOG 0831, CDR0000647146, NCI-2011-01934
Study First Received: June 30, 2009
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
sexual dysfunction
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Erectile Dysfunction
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Mental Disorders
Neoplasms
Neoplasms by Site
Prostatic Diseases
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Urogenital Neoplasms
Phosphodiesterase 5 Inhibitors
Tadalafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014