A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)

May 7, 2026 updated by: Aragon Pharmaceuticals, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investigational medication but does not contain any active medication, a dummy pill.

Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in previous Phase 2 studies. These studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Study participants will take the oral investigational medication daily. One cycle of study treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your cancer respond to the study medication.

In order for the researchers to evaluate and compare the study results, there are two different study groups. Study participants will be randomly (like flipping a coin) assigned to one of these groups:

  • One group will receive their current treatment along with the investigational medication
  • One group will receive their current medications along with a placebo

The investigational medication will be given to 2 out of every 3 study participants. Neither you nor the study staff will know which group you are in. However, in case of a medical emergency, your study doctor can quickly find out which treatment group you are in.

All participants will continue to receive their current treatment along with either the investigational medication or a placebo. The selections will be random, and you may remain on investigational treatment until your disease worsens, or until significant side effects occur or you can no longer tolerate treatment.

Study Type

Interventional

Enrollment (Actual)

1207

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Australia
      • Adelaide, Australia
      • Box Hill, Australia
      • Camperdown, Australia
      • Darlinghurst, Australia
      • Geelong, Australia
      • Gosford, Australia
      • Hobart, Australia
      • Kogarah, Australia
      • Liverpool, Australia
      • Melbourne, Australia
      • Nedlands, Australia
      • Parkville, Australia
      • South Woodville, Australia
      • Southport, Australia
      • Sydney, Australia
      • Tweed Heads, Australia
      • Wollongong, Australia
  • Austria
      • Graz, Austria
      • Innsbruck, Austria
      • Linz, Austria
      • Vienna, Austria
  • Belgium
      • Brussels, Belgium
      • Ghent, Belgium
      • Kortrijk, Belgium
      • Leuven, Belgium
      • Liège, Belgium
      • Ottignies, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada
      • Kelowna, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
      • Saint John, New Brunswick, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Brampton, Ontario, Canada
      • Brantford, Ontario, Canada
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • North York, Ontario, Canada
      • Oakville, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Owen Sound, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Gatineau, Quebec, Canada
      • Granby, Quebec, Canada
      • Greenfield Park, Quebec, Canada
      • Laval, Quebec, Canada
      • Montreal, Quebec, Canada
      • Pointe-Claire, Quebec, Canada
      • Québec, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Czechia
      • Liberec, Czechia
      • Olomouc, Czechia
      • Opava, Czechia
      • Pilsen, Czechia
      • Prague, Czechia
  • Denmark
      • Aalborg C, Denmark
      • Copenhagen, Denmark
      • Odense, Denmark
      • Roskilde, Denmark
  • Finland
      • Helsinki, Finland
      • Oulu, Finland
      • Seinäjoki, Finland
      • Tampere, Finland
      • Turku, Finland
  • France
      • Angers, France
      • Besançon, France
      • Bordeaux, France
      • Caen Cédex 05, France
      • Clermont-Ferrand, France
      • Hyers, France
      • La Roche-sur-Yon, France
      • Le Mans, France
      • Lille Cedex N/a, France
      • Lyon, France
      • Marseille, France
      • Nice, France
      • Nîmes, France
      • Paris, France
      • Reims, France
      • Rennes, France
      • Rouen, France
      • Saint-Grégoire, France
      • Saint-Herblain, France
      • Strasbourg, France
      • Suresnes, France
      • Tours, France
      • Vandœuvre-lès-Nancy, France
  • Germany
      • Aachen, Germany
      • Bergisch Gladbach, Germany
      • Berlin, Germany
      • Braunschweig, Germany
      • Cologne, Germany
      • Duisburg, Germany
      • Emmendingen, Germany
      • Frankfurt am Main, Germany
      • Greifswald, Germany
      • Göttingen, Germany
      • Hamburg, Germany
      • Hanover, Germany
      • Heidelberg, Germany
      • Heinsberg, Germany
      • Homburg/Saar, Germany
      • Jena, Germany
      • Kiel, Germany
      • Kirchheim unter Teck, Germany
      • Magdeburg, Germany
      • Mainz, Germany
      • Mannheim, Germany
      • Marburg, Germany
      • Mettmann, Germany
      • Müllheim, Germany
      • Münster, Germany
      • Nürtingen, Germany
      • Regensburg, Germany
      • Rostock, Germany
      • Tübingen, Germany
      • Weiden, Germany
      • Wilhelmshaven, Germany
      • Wuppertan, Germany
      • Zirndorf, Germany
  • Hungary
      • Budapest, Hungary
      • Miskolc, Hungary
      • Nyíregyhá, Hungary
      • Sopron, Hungary
      • Szentes, Hungary
  • Israel
      • Haifa, Israel
      • Jeruselem, Israel
      • Kfar Saba, Israel
      • Petah Tikva, Israel
      • Ramat Gan, Israel
      • Tel Aviv, Israel
      • Ẕerifin, Israel
  • Japan
      • Akita, Japan
      • Fukuoka, Japan
      • Gifu, Japan
      • Hakodate, Japan
      • Hiroshima, Japan
      • Hokkaido, Japan
      • Kanazawa, Japan
      • Kashiwa, Japan
      • Kita-Gun, Japan
      • Kobe, Japan
      • Koshigaya, Japan
      • Kumamoto, Japan
      • Kurume, Japan
      • Matsuyama, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Nagoya, Japan
      • Niigata, Japan
      • Osaka, Japan
      • Sagamihara, Japan
      • Sakura, Japan
      • Sapporo, Japan
      • Shinjuku-Ku, Japan
      • Tokushima, Japan
      • Tokyo, Japan
      • Ube, Japan
      • Wakayama, Japan
      • Yokohama, Japan
      • Ōsaka-sayama, Japan
  • Netherlands
      • Alkmaar, Netherlands
      • Eindhoven, Netherlands
      • Hoofddorp, Netherlands
      • Leidschendam, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Hamilton, New Zealand
      • Nelson, New Zealand
      • Tauranga, New Zealand
      • Whangarei, New Zealand
  • Norway
      • Nordbyhagen, Norway
  • Poland
      • Bialystok, Poland
      • Bydgoszcz, Poland
      • Gdansk, Poland
      • Kutno, Poland
      • Lodz, Poland
      • Poznan, Poland
      • Szczecin, Poland
      • Torun, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
  • Romania
      • Baia Mare, Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Târgu Mureş, Romania
  • Russia
      • Barnaul, Russia
      • Ivanovo, Russia
      • Moscow, Russia
      • Obninsk, Russia
      • Omsk, Russia
      • Ryazan, Russia
      • Saint Petersburg, Russia
      • Ufa, Russia
      • Yaroslavl, Russia
      • Yekaterinburg, Russia
  • Slovakia
      • Banská Bystrica, Slovakia
      • Bratislava, Slovakia
      • Martin, Slovakia
      • Nitra, Slovakia
      • Trenčín, Slovakia
  • South Korea
      • Daegu, South Korea
      • Gwangju, South Korea
      • Pusan, South Korea
      • Seongnam, South Korea
      • Seoul, South Korea
  • Spain
      • A Coruña, Spain
      • Badalona, Spain
      • Barcelona, Spain
      • Castellon, Spain
      • Girona, Spain
      • Guadalajara, Spain
      • Jerez de la Frontera, Spain
      • Las Palmas de Gran Canaria, Spain
      • Madrid, Spain
      • Murcia, Spain
      • Málaga, Spain
      • Palma de Mallorca, Spain
      • Pamplona, Spain
      • Sabadell, Spain
      • Salamanca, Spain
      • San Sebastián de los Reyes, Spain
      • Santander, Spain
      • Seville, Spain
      • Valencia, Spain
  • Sweden
      • Gothenburg, Sweden
      • Stockholm, Sweden
      • Umeå, Sweden
      • Uppsala, Sweden
      • Örebro, Sweden
  • Taiwan
      • Kaohsiung City, Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
      • Taoyuan County, Taiwan
  • United Kingdom
      • Blackburn, United Kingdom
      • Cambridge, United Kingdom
      • Cardiff, United Kingdom
      • Dundee, United Kingdom
      • Glasgow, United Kingdom
      • Guildford, United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Maidstone, United Kingdom
      • Metropolitan Borough of Wirral, United Kingdom
      • Nottingham, United Kingdom
      • Plymouth, United Kingdom
      • Southampton, United Kingdom
      • Surrey, United Kingdom
      • Swansea, United Kingdom
      • Wolverhampton, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Chandler, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Duarte, California, United States
      • Fullerton, California, United States
      • Laguna Woods, California, United States
      • Los Angeles, California, United States
      • Orange, California, United States
      • Roseville, California, United States
      • Sacramento, California, United States
      • San Bernardino, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Santa Monica, California, United States
      • Sherman Oaks, California, United States
      • Stanford, California, United States
      • Tarzana, California, United States
      • Torrance, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Englewood, Colorado, United States
      • Glenwood Springs, Colorado, United States
      • Grand Junction, Colorado, United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States
    • Florida
      • Aventura, Florida, United States
      • Boca Raton, Florida, United States
      • Bradenton, Florida, United States
      • Daytona Beach, Florida, United States
      • Fort Myers, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • Orlando, Florida, United States
      • Sarasota, Florida, United States
      • St. Petersburg, Florida, United States
      • Wellington, Florida, United States
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Decatur, Illinois, United States
      • Maywood, Illinois, United States
      • Melrose Park, Illinois, United States
    • Indiana
      • Carmel, Indiana, United States
      • Jeffersonville, Indiana, United States
      • Muncie, Indiana, United States
    • Iowa
      • West Des Moines, Iowa, United States
    • Kansas
      • Westwood, Kansas, United States
      • Wichita, Kansas, United States
    • Louisiana
      • Metairie, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Baltimore, Maryland, United States
      • Rockville, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Lansing, Michigan, United States
      • Minneapolis, Michigan, United States
      • Royal Oak, Michigan, United States
    • Minnesota
      • Duluth, Minnesota, United States
    • Mississippi
      • Bay Saint Louis, Mississippi, United States
      • Southaven, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Montana
      • Missoula, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Hooksett, New Hampshire, United States
    • New Jersey
      • Hackensack, New Jersey, United States
      • Lawrenceville, New Jersey, United States
      • Morristown, New Jersey, United States
      • Mount Laurel, New Jersey, United States
      • New Brunswick, New Jersey, United States
      • Voorhees Township, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
      • Oneida, New York, United States
      • Poughkeepsie, New York, United States
      • Syracuse, New York, United States
      • The Bronx, New York, United States
    • North Carolina
      • Concord, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Greenville, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Middleburg Heights, Ohio, United States
      • Middletown, Ohio, United States
    • Oregon
      • Bend, Oregon, United States
      • Portland, Oregon, United States
      • Tualatin, Oregon, United States
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States
      • Bryn Mawr, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greenville, South Carolina, United States
      • Myrtle Beach, South Carolina, United States
      • West Columbia, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Abilene, Texas, United States
      • Amarillo, Texas, United States
      • Dallas, Texas, United States
      • Fort Sam Houston, Texas, United States
      • Houston, Texas, United States
      • McAllen, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Burien, Washington, United States
      • Edmonds, Washington, United States
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm A: Apalutamide
Drug: Apalutamide
240 mg tablets administered by mouth on a continuous once daily dosing regimen
Placebo Comparator: Treatment Arm B: Placebo
Drug: Placebo
Matched placebo tablets administered by mouth on a continuous once daily dosing regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 43 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Metastasis (TTM)
Time Frame: Up to approximately 43 Months
Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Up to approximately 43 Months
Progression-free Survival (PFS)
Time Frame: Up to approximately 43 Months
PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
Up to approximately 43 Months
Time to Symptomatic Progression
Time Frame: Up to approximately 43 Months
Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
Up to approximately 43 Months
Overall Survival
Time Frame: Up to approximately 43 months
Overall survival was defined as the time from randomization to the date of death due to any cause.
Up to approximately 43 months
Time to Initiation of Cytotoxic Chemotherapy
Time Frame: Up to approximately 43 months
Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Up to approximately 43 months

Collaborators and Investigators

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

Sponsor

Aragon Pharmaceuticals, Inc.

Investigators

  • Study Director: Aragon Pharmaceuticals, Inc. Clinical Trial, Aragon Pharmaceuticals, Inc.

Publications and helpful links

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

General Publications

Study record dates

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

Study Major Dates

Study Start (Actual)

October 14, 2013

Primary Completion (Actual)

May 19, 2017

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimated)

September 19, 2013

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR102931
  • 2012-004322-24 (EudraCT Number)
  • ARN-509-003; 56021927PCR1007 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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

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