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
3 other identifiers
interventional
242
2 countries
192
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
Started Nov 2009
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
July 27, 2016
CompletedFebruary 14, 2018
January 1, 2018
3.1 years
June 30, 2009
April 18, 2016
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline and 30 weeks from the start of radiation therapy
Secondary Outcomes (6)
Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT
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)
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
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
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
Baseline, week 30 and years 1 and 2 after the start of treatment
- +1 more secondary outcomes
Other Outcomes (2)
Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT
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
Baseline, week 30 and years 1 and 2 after the start of treatment
Study Arms (2)
Tadalafil
EXPERIMENTALTadalafil
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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" \[response 5\]
- +2 more criteria
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (192)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Providence Hospital
Mobile, Alabama, 36608, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, 85260, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, 85704, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Enloe Medical Center
Chico, California, 95926, United States
Saint Agnes Medical Center
Fresno, California, 93720, United States
Veterans Administration Long Beach Medical Center
Long Beach, California, 90822, United States
Northridge Hospital Medical Center
Northridge, California, 91325, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Radiological Associates of Sacramento
Sacramento, California, 95815, United States
Mercy General Hospital Radiation Oncology Center
Sacramento, California, 95819, United States
UCSF-Mount Zion
San Francisco, California, 94115, United States
California Pacific Medical Center
San Francisco, California, 94118, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
Sutter Solano Medical Center
Vallejo, California, 94589, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Broward Health North
Deerfield Beach, Florida, 33064, United States
University of Florida
Gainesville, Florida, 32610, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Cancer Specialists of North Florida-Southside
Jacksonville, Florida, 32207, United States
University of Florida Health Science Center
Jacksonville, Florida, 32209, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Cancer Specialists of North Florida-Baptist South
Jacksonville, Florida, 32258, United States
Cancer Specialists of North Florida-Beaches
Jacksonville Beach, Florida, 32250, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
21st Century Oncology-Orange Park
Orange Park, Florida, 32073, United States
21st Century Oncology-Palatka
Palatka, Florida, 32177, United States
Cancer Specialists of North Florida-Saint Augustine
Saint Augustine, Florida, 32086, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Advocate Lutheran General Hospital.
Park Ridge, Illinois, 60068, United States
Saint John's Hospital
Springfield, Illinois, 62702, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, 46016, United States
IU Health Bloomington
Bloomington, Indiana, 47403, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, 46804, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
IU Health Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Ochsner Clinic CCOP
New Orleans, Louisiana, 70121, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
Saint Anne's Hospital
Fall River, Massachusetts, 02721, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Huron Valley-Sinai Hospital
Commerce, Michigan, 48382, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
McLaren-Flint
Flint, Michigan, 48532, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Siteman Cancer Center - Saint Peters
City of Saint Peters, Missouri, 63376, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Barnes-Jewish West County Hospital
St Louis, Missouri, 63141, United States
Good Samaritan Hospital
Kearney, Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Concord Hospital
Concord, New Hampshire, 03301, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
Elliot Hospital
Manchester, New Hampshire, 03103, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
New York Oncology Hematology PC - Albany
Albany, New York, 12206, United States
Southside Hospital
Bay Shore, New York, 11706, United States
Lourdes Hospital
Binghamton, New York, 13905, United States
Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
Brooklyn, New York, 11209, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Columbia University Medical Center
New York, New York, 10032, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
High Point Regional Hospital
High Point, North Carolina, 27261, United States
The Coleman Radiation Center-Carteret General Hospital
Morehead City, North Carolina, 28557, United States
CarolinaEast Health System-Medical Center
New Bern, North Carolina, 28560, United States
South Atlantic Radiation Oncology
Supply, North Carolina, 28462, United States
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, 28401, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Summa Barberton Hospital
Barberton, Ohio, 44203, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, 44130, United States
UHHS-Chagrin Highlands Medical Center
Orange, Ohio, 44122, United States
Cancer Care Center, Incorporated
Salem, Ohio, 44460, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Three Rivers Community Hospital
Grants Pass, Oregon, 97527, United States
Providence Medford Medical Center
Medford, Oregon, 97504, United States
Rogue Valley Medical Center
Medford, Oregon, 97504, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Western Oncology Research Consortium
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331, United States
Academic Urology Prostate Center
King of Prussia, Pennsylvania, 19406, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17405, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Texas Oncology-Denton South
Denton, Texas, 76210, United States
The Klabzuba Cancer Center
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0565, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Texas Cancer Center-Sherman
Sherman, Texas, 75090, United States
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604-3337, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Virginia Mason CCOP
Seattle, Washington, 98101, United States
Compass Oncology Vancouver
Vancouver, Washington, 98684, United States
Appleton Medical Center
Appleton, Wisconsin, 54911, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Gundersen Lutheran
La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, 53066-3896, United States
Door County Cancer Center
Sturgeon Bay, Wisconsin, 54235-1495, United States
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
BCCA-Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
CHUQ - Pavilion Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Related Publications (1)
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.
PMID: 24691606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The protocol endpoint "Patient-related predictors of erectile function" refers to modeling of the first two outcome measures, and is therefore reported as additional statistical analyses for those outcome measures.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Onoclogy
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Watkins Bruner, RN, PhD
Abramson Cancer Center at Penn Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 2, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2012
Study Completion
November 1, 2014
Last Updated
February 14, 2018
Results First Posted
July 27, 2016
Record last verified: 2018-01