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: April 7, 2014
Last verified: April 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
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States, 85381
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States, 94611
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Mercy General Hospital
Sacramento, California, United States, 95819
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States, 94080
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
Sutter Solano Medical Center
Vallejo, California, United States, 94589
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
North Broward Medical Center
Dearfield Beach, Florida, United States, 33064-3596
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States, 32250
Baptist Medical Center South
Jascksonville, Florida, United States, 32258
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States, 32073
Florida Cancer Center - Palatka
Palatka, Florida, United States, 32177
Flagler Cancer Center
Saint Augustine, Florida, United States, 32086
United States, Georgia
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center - East
Honolulu, Hawaii, United States, 96817
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, United States, 47403
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States, 46804
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States, 04240
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Central Maryland Oncology Center
Columbia, Maryland, United States, 21044
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Charach Cancer Center at Huron Valley - Sinai Hospital
Commerce, Michigan, United States, 48382
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
United States, Minnesota
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
United Hospital
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
Saint Peters, Missouri, United States, 63376
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, United States, 03301
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States, 03820
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, United States, 88011
United States, New York
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States, 12206
Southside Hospital
Bay Shore, New York, United States, 11706
Lourdes Regional Cancer Center
Binghamton, New York, United States, 13905
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Duke Cancer Institute
Durham, North Carolina, United States, 27710
High Point Regional Hospital
High Point, North Carolina, United States, 27261
Coleman Radiation Oncology Center at Carter General Hospital
Morehead City, North Carolina, United States, 28557
CarolinaEast Cancer Care
New Bern, North Carolina, United States, 28560
South Atlantic Radiation Oncology, LLC
Supply, North Carolina, United States, 28462
Coastal Carolina Radiation Oncology Center
Wilmington, North Carolina, United States, 28401
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health 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 Cancer Center
Sylvania, Ohio, United States, 43560
UHHS Westlake Medical Center
Westlake, Ohio, United States, 44145
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States, 97401
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
Providence Cancer Center at PMCC
Medford, Oregon, United States, 97504
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
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
Philadelphia, Pennsylvania, United States, 19111-2497
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, South Carolina
Gibbs Regional Cancer Center at 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, PA at Texas Cancer Center - Denton South
Denton, Texas, United States, 76210
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
West Texas Cancer Center
Odessa, Texas, United States, 79761
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States, 98684
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States, 54601
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
West Allis Memorial Hospital
West Allis, Wisconsin, United States, 53227
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
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: April 7, 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:
Prostatic Neoplasms
Sexual Dysfunctions, Psychological
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual and Gender Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014