A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
SPARTAN
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer
3 other identifiers
interventional
1,207
24 countries
375
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Longer than P75 for phase_3
375 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
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 19, 2013
CompletedStudy Start
First participant enrolled
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2017
CompletedResults Posted
Study results publicly available
June 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedApril 13, 2026
April 1, 2026
3.6 years
September 17, 2013
May 18, 2018
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography \[CT\] or magnetic resonance imaging \[MRI\] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Up to approximately 43 Months
Secondary Outcomes (5)
Time to Metastasis (TTM)
Up to approximately 43 Months
Progression-free Survival (PFS)
Up to approximately 43 Months
Time to Symptomatic Progression
Up to approximately 43 Months
Overall Survival
Up to approximately 43 months
Time to Initiation of Cytotoxic Chemotherapy
Up to approximately 43 months
Study Arms (2)
Treatment Arm A: Apalutamide
EXPERIMENTALTreatment Arm B: Placebo
PLACEBO COMPARATORInterventions
240 mg tablets administered by mouth on a continuous once daily dosing regimen
Matched placebo tablets administered by mouth on a continuous once daily dosing regimen
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equal to (\<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy)
- Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises, at least 1 week apart, with the last PSA greater than (\>) 2 nanogram per milliliter (ng/mL)
- Maintain castrate levels of testosterone within 4 weeks prior to randomization and throughout the study
- Patients currently receiving bone loss prevention treatment with bone-sparing agents must be on stable doses for at least 4 weeks prior to randomization
- Patients who received a first generation anti-androgen (for example, bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND must show continuing disease (PSA) progression (an increase in PSA) after washout
- At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors, estrogens, and any other anti-cancer therapy prior to randomization
- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
- Eastern Cooperative Oncology Group Performance Status 0 or 1
- Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade \<= 1 or baseline prior to randomization
- Adequate organ function according to protocol-defined criteria
- Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility
You may not qualify if:
- Presence of confirmed distant metastases, including central nervous system and vertebral or meningeal involvement
- Symptomatic local or regional disease requiring medical intervention
- Prior treatment with second generation anti-androgens
- Prior treatment with CYP17 inhibitors
- Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer
- Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
- History of seizure or condition that may pre-dispose to seizure
- Concurrent therapy with protocol-defined excluded medications
- History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months prior to randomization; uncontrolled hypertension; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (379)
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Birmingham, Alabama, United States
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Anchorage, Alaska, United States
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Chandler, Arizona, United States
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Tucson, Arizona, United States
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Duarte, California, United States
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Fullerton, California, United States
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Laguna Woods, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Sherman Oaks, California, United States
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Stanford, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Glenwood Springs, Colorado, United States
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Grand Junction, Colorado, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Daytona Beach, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Wellington, Florida, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Maywood, Illinois, United States
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Melrose Park, Illinois, United States
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Carmel, Indiana, United States
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Jeffersonville, Indiana, United States
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Muncie, Indiana, United States
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West Des Moines, Iowa, United States
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Westwood, Kansas, United States
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Wichita, Kansas, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Minneapolis, Michigan, United States
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Royal Oak, Michigan, United States
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Duluth, Minnesota, United States
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Bay Saint Louis, Mississippi, United States
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Southaven, Mississippi, United States
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Kansas City, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Hooksett, New Hampshire, United States
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Hackensack, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Morristown, New Jersey, United States
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Mount Laurel, New Jersey, United States
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New Brunswick, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Oneida, New York, United States
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Poughkeepsie, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Concord, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Middleburg Heights, Ohio, United States
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Middletown, Ohio, United States
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Bend, Oregon, United States
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Portland, Oregon, United States
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Tualatin, Oregon, United States
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Bala-Cynwyd, Pennsylvania, United States
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Bryn Mawr, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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West Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Fort Sam Houston, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Burien, Washington, United States
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Edmonds, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Green Bay, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Adelaide, Australia
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Box Hill, Australia
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Camperdown, Australia
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Darlinghurst, Australia
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Geelong, Australia
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Gosford, Australia
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Hobart, Australia
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Kogarah, Australia
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Liverpool, Australia
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Melbourne, Australia
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Nedlands, Australia
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Parkville, Australia
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South Woodville, Australia
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Southport, Australia
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Sydney, Australia
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Tweed Heads, Australia
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Wollongong, Australia
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Graz, Austria
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Innsbruck, Austria
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Linz, Austria
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Vienna, Austria
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Brussels, Belgium
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Ghent, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Liège, Belgium
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Ottignies, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Abbotsford British Columbia, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Owen Sound, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Granby, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Liberec, Czechia
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Olomouc, Czechia
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Opava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Aalborg C, Denmark
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Copenhagen, Denmark
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Odense, Denmark
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Roskilde, Denmark
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Helsinki, Finland
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Oulu, Finland
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Seinäjoki, Finland
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Tampere, Finland
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Turku, Finland
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Angers, France
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Besançon, France
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Bordeaux, France
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Caen Cédex 05, France
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Clermont-Ferrand, France
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Hyers, France
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La Roche-sur-Yon, France
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Le Mans, France
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Lille Cedex N/a, France
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Lyon, France
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Nice, France
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Saint-Grégoire, France
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Saint-Herblain, France
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Strasbourg, France
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Vandœuvre-lès-Nancy, France
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Aachen, Germany
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Braunschweig, Germany
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Cologne, Germany
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Emmendingen, Germany
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Frankfurt am Main, Germany
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Göttingen, Germany
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Greifswald, Germany
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Heidelberg, Germany
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Heinsberg, Germany
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Homburg/Saar, Germany
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Kirchheim unter Teck, Germany
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Mannheim, Germany
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Marburg, Germany
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Mettmann, Germany
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Müllheim, Germany
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Nürtingen, Germany
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Rostock, Germany
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Tübingen, Germany
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Weiden, Germany
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Wilhelmshaven, Germany
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Wuppertan, Germany
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Zirndorf, Germany
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Budapest, Hungary
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Miskolc, Hungary
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Nyíregyhá, Hungary
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Sopron, Hungary
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Szentes, Hungary
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Haifa, Israel
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Jeruselem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Akita, Japan
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Fukuoka, Japan
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Gifu, Japan
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Hakodate, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Kanazawa, Japan
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Kashiwa, Japan
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Kita-Gun, Japan
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Kobe, Japan
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Koshigaya, Japan
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Kumamoto, Japan
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Matsuyama, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Niigata, Japan
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Sapporo, Japan
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Shinjuku-Ku, Japan
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Tokushima, Japan
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Tokyo, Japan
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Ube, Japan
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Wakayama, Japan
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Yokohama, Japan
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Alkmaar, Netherlands
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Eindhoven, Netherlands
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Hoofddorp, Netherlands
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Leidschendam, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Hamilton, New Zealand
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Nelson, New Zealand
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Tauranga, New Zealand
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Whangarei, New Zealand
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Nordbyhagen, Norway
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdansk, Poland
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Kutno, Poland
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Lodz, Poland
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Poznan, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Baia Mare, Romania
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Târgu Mureş, Romania
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Barnaul, Russia
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Ivanovo, Russia
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Moscow, Russia
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Obninsk, Russia
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Omsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Ufa, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Martin, Slovakia
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Nitra, Slovakia
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Trenčín, Slovakia
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Daegu, South Korea
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Gwangju, South Korea
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Pusan, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Badalona, Spain
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Barcelona, Spain
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Castellon, Spain
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Girona, Spain
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Guadalajara, Spain
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Jerez de la Frontera, Spain
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Las Palmas de Gran Canaria, Spain
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Madrid, Spain
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Málaga, Spain
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Murcia, Spain
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Palma de Mallorca, Spain
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Pamplona, Spain
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Sabadell, Spain
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Salamanca, Spain
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San Sebastián de los Reyes, Spain
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Santander, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Örebro, Sweden
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Stockholm, Sweden
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Umeå, Sweden
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Uppsala, Sweden
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Blackburn, United Kingdom
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Dundee, United Kingdom
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Glasgow, United Kingdom
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Guildford, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Maidstone, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Southampton, United Kingdom
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Surrey, United Kingdom
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Swansea, United Kingdom
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Wolverhampton, United Kingdom
Related Publications (11)
Ni X, Sui J, Wang B, Wang H, Freedland SJ, Ye D, Zhu Y. Lower Testosterone Level and Metastases-Free Survival in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Treated With Novel Antiandrogens: A Post Hoc Analysis of SPARTAN and ARAMIS. J Urol. 2025 Jul;214(1):10-17. doi: 10.1097/JU.0000000000004545. Epub 2025 Mar 25.
PMID: 40132221DERIVEDFeng FY, Smith MR, Saad F, Mobadersany P, Tian SK, Yip SSF, Greshock J, Khan N, Yu MK, McCarthy S, Brookman-May SD, Bourla AB, Todorovic T, Yamashita R, Huang HC, Royce TJ, Showalter TN, Griffin J, Mitani A, Esteva A, Small EJ. Digital Pathology-Based Multimodal Artificial Intelligence Scores and Outcomes in a Randomized Phase III Trial in Men With Nonmetastatic Castration-Resistant Prostate Cancer. JCO Precis Oncol. 2025 Jan;9:e2400653. doi: 10.1200/PO-24-00653. Epub 2025 Jan 31.
PMID: 39889245DERIVEDRoy S, Malone S, Wing K, Chowdhury S, Kishan AU, Sun Y, Wallis CJD, Mohamad O, Jia AY, Swami U, Zaorsky NG, Morgan SC, Ong M, Agarwal N, Spratt DE, Small EJ, Saad F. Prior Local Therapy and First-Line Apalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of the SPARTAN Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2439434. doi: 10.1001/jamanetworkopen.2024.39434.
PMID: 39405060DERIVEDKarsh LI, Bevans KB, Saad F, Chung BH, Oudard S, Brookman-May SD, McCarthy SA, Smith MR, Chi KN, Small EJ, Agarwal N. Prostate-specific antigen and health-related quality of life in individuals with advanced prostate cancer treated with apalutamide: a plain language summary of the SPARTAN and TITAN studies. Future Oncol. 2024;20(35):2689-2698. doi: 10.1080/14796694.2024.2384257. Epub 2024 Aug 20.
PMID: 39163505DERIVEDShen J, Chowdhury S, Agarwal N, Karsh LI, Oudard S, Gartrell BA, Feyerabend S, Saad F, Pieczonka CM, Chi KN, Brookman-May SD, Rooney B, Bhaumik A, McCarthy SA, Bevans KB, Mundle SD, Small EJ, Smith MR, Graff JN. Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN. Br J Cancer. 2024 Jan;130(1):73-81. doi: 10.1038/s41416-023-02492-8. Epub 2023 Nov 11.
PMID: 37951974DERIVEDPollock Y, Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik B, Olmos D, Lee JY, Uemura H, Bhaumik A, Londhe A, Rooney B, Brookman-May SD, De Porre P, Mundle SD, Small EJ. Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide. Prostate Cancer Prostatic Dis. 2023 Mar;26(1):156-161. doi: 10.1038/s41391-022-00592-9. Epub 2022 Oct 8.
PMID: 36209239DERIVEDChowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19.
PMID: 34797506DERIVEDUemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0.
PMID: 32878613DERIVEDSmith MR, Mehra M, Nair S, Lawson J, Small EJ. Relationship Between Metastasis-free Survival and Overall Survival in Patients With Nonmetastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2020 Apr;18(2):e180-e189. doi: 10.1016/j.clgc.2019.10.030. Epub 2019 Nov 6.
PMID: 31980408DERIVEDSaad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, Graff JN, McQuarrie K, Li S, Hudgens S, Lawson J, Lopez-Gitlitz A, Yu MK, Smith MR, Small EJ. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1404-1416. doi: 10.1016/S1470-2045(18)30456-X. Epub 2018 Sep 10.
PMID: 30213449DERIVEDSmith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. doi: 10.1056/NEJMoa1715546. Epub 2018 Feb 8.
PMID: 29420164DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
These results are up to clinical cutoff (CCO) date (that is, 19 May 2017).
Results Point of Contact
- Title
- Senior Medical Director, WC Clinical Oncology Department
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Aragon Pharmaceuticals, Inc. Clinical Trial
Aragon Pharmaceuticals, Inc.
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, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 19, 2013
Study Start
October 14, 2013
Primary Completion
May 19, 2017
Study Completion (Estimated)
December 31, 2027
Last Updated
April 13, 2026
Results First Posted
June 19, 2018
Record last verified: 2026-04