AzTrials
AzTrials

Prostatic NeoplasmsPhase 3SPARTANNCT01946204

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

A Phase 3 study testing Apalutamide in people with Prostatic Neoplasms, run by Aragon Pharmaceuticals, Inc. at 379 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Apalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,207 participants
Where
379 sitesin 25 countries
Study dates
14 Oct 2013to 31 Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

379 sites in 25 countries.

379 sites in 25 countries

United States122 sites

  • Study site

    Abilene, Texas

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anchorage, Alaska

  • Study site

    Annapolis, Maryland

  • Study site

    Aventura, Florida

  • Study site

    Bala-Cynwyd, Pennsylvania

  • Study site

    Baltimore, Maryland

  • Study site

    Bay Saint Louis, Mississippi

  • Study site

    Bend, Oregon

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Bradenton, Florida

  • Study site

    Bryn Mawr, Pennsylvania

  • Study site

    Burien, Washington

  • Study site

    Carmel, Indiana

  • Study site

    Chandler, Arizona

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Concord, North Carolina

  • Study site

    Dallas, Texas

  • Study site

    Daytona Beach, Florida

  • Study site

    Decatur, Illinois

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Duarte, California

  • Study site

    Duluth, Minnesota

  • Study site

    Edmonds, Washington

  • Study site

    Englewood, Colorado

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Sam Houston, Texas

  • Study site

    Fullerton, California

  • Study site

    Glenwood Springs, Colorado

  • Study site

    Grand Junction, Colorado

  • Study site

    Green Bay, Wisconsin

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Hialeah, Florida

  • Study site

    Hooksett, New Hampshire

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Jeffersonville, Indiana

  • Study site

    Kansas City, Missouri

  • Study site

    Laguna Woods, California

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Las Vegas, Nevada

  • Study site

    Lawrenceville, New Jersey

  • Study site

    Los Angeles, California

  • Study site

    Madison, Wisconsin

  • Study site

    Maywood, Illinois

  • Study site

    McAllen, Texas

  • Study site

    Melrose Park, Illinois

  • Study site

    Memphis, Tennessee

  • Study site

    Meridian, Idaho

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Middletown, Ohio

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mineola, New York

  • Study site

    Minneapolis, Michigan

  • Study site

    Missoula, Montana

  • Study site

    Morristown, New Jersey

  • Study site

    Mount Laurel, New Jersey

  • Study site

    Muncie, Indiana

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Omaha, Nebraska

  • Study site

    Oneida, New York

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Poughkeepsie, New York

  • Study site

    Richmond, Virginia

  • Study site

    Rockville, Maryland

  • Study site

    Roseville, California

  • Study site

    Royal Oak, Michigan

  • Study site

    Sacramento, California

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    San Bernardino, California

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Monica, California

  • Study site

    Sarasota, Florida

  • Study site

    Seattle, Washington

  • Study site

    Sherman Oaks, California

  • Study site

    Southaven, Mississippi

  • Study site

    St. Petersburg, Florida

  • Study site

    Stanford, California

  • Study site

    Syracuse, New York

  • Study site

    Tacoma, Washington

  • Study site

    Tarzana, California

  • Study site

    The Bronx, New York

  • Study site

    Torrance, California

  • Study site

    Towson, Maryland

  • Study site

    Tualatin, Oregon

  • Study site

    Tucson, Arizona

  • Study site

    Virginia Beach, Virginia

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Warwick, Rhode Island

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wellington, Florida

  • Study site

    West Columbia, South Carolina

  • Study site

    West Des Moines, Iowa

  • Study site

    Westwood, Kansas

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Germany33 sites

  • Study site

    Aachen

  • Study site

    Bergisch Gladbach

  • Study site

    Berlin

  • Study site

    Braunschweig

  • Study site

    Cologne

  • Study site

    Duisburg

  • Study site

    Emmendingen

  • Study site

    Frankfurt am Main

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Heinsberg

  • Study site

    Homburg/Saar

  • Study site

    Jena

  • Study site

    Kiel

  • Study site

    Kirchheim unter Teck

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Mannheim

  • Study site

    Marburg

  • Study site

    Mettmann

  • Study site

    Müllheim

  • Study site

    Münster

  • Study site

    Nürtingen

  • Study site

    Regensburg

  • Study site

    Rostock

  • Study site

    Tübingen

  • Study site

    Weiden

  • Study site

    Wilhelmshaven

  • Study site

    Wuppertan

  • Study site

    Zirndorf

Other trials in Germany

Japan29 sites

  • Study site

    Akita

  • Study site

    Fukuoka

  • Study site

    Gifu

  • Study site

    Hakodate

  • Study site

    Hiroshima

  • Study site

    Hokkaido

  • Study site

    Kanazawa

  • Study site

    Kashiwa

  • Study site

    Kita-Gun

  • Study site

    Kobe

  • Study site

    Koshigaya

  • Study site

    Kumamoto

  • Study site

    Kurume

  • Study site

    Matsuyama

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Niigata

  • Study site

    Osaka

  • Study site

    Ōsaka-sayama

  • Study site

    Sagamihara

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Shinjuku-Ku

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Ube

  • Study site

    Wakayama

  • Study site

    Yokohama

Other trials in Japan

Canada27 sites

  • Study site

    Abbotsford British Columbia, British Columbia

  • Study site

    Barrie, Ontario

  • Study site

    Brampton, Ontario

  • Study site

    Brantford, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Gatineau, Quebec

  • Study site

    Granby, Quebec

  • Study site

    Greenfield Park, Quebec

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    Laval, Quebec

  • Study site

    London, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    North York, Ontario

  • Study site

    Oakville, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Owen Sound, Ontario

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Saint John, New Brunswick

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

France23 sites

  • Study site

    Angers

  • Study site

    Besançon

  • Study site

    Bordeaux

  • Study site

    Caen Cédex 05

  • Study site

    Clermont-Ferrand

  • Study site

    Hyers

  • Study site

    La Roche-sur-Yon

  • Study site

    Le Mans

  • Study site

    Lille Cedex N/a

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Nice

  • Study site

    Nîmes

  • Study site

    Paris

  • Study site

    Reims

  • Study site

    Rennes

  • Study site

    Rouen

  • Study site

    Saint-Grégoire

  • Study site

    Saint-Herblain

  • Study site

    Strasbourg

  • Study site

    Suresnes

  • Study site

    Tours

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Spain19 sites

  • Study site

    A Coruña

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    Castellon

  • Study site

    Girona

  • Study site

    Guadalajara

  • Study site

    Jerez de la Frontera

  • Study site

    Las Palmas de Gran Canaria

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Murcia

  • Study site

    Palma de Mallorca

  • Study site

    Pamplona

  • Study site

    Sabadell

  • Study site

    Salamanca

  • Study site

    San Sebastián de los Reyes

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Australia17 sites

  • Study site

    Adelaide

  • Study site

    Box Hill

  • Study site

    Camperdown

  • Study site

    Darlinghurst

  • Study site

    Geelong

  • Study site

    Gosford

  • Study site

    Hobart

  • Study site

    Kogarah

  • Study site

    Liverpool

  • Study site

    Melbourne

  • Study site

    Nedlands

  • Study site

    Parkville

  • Study site

    South Woodville

  • Study site

    Southport

  • Study site

    Sydney

  • Study site

    Tweed Heads

  • Study site

    Wollongong

Other trials in Australia

United Kingdom16 sites

  • Study site

    Blackburn

  • Study site

    Cambridge

  • Study site

    Cardiff

  • Study site

    Dundee

  • Study site

    Glasgow

  • Study site

    Guildford

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Maidstone

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Nottingham

  • Study site

    Plymouth

  • Study site

    Southampton

  • Study site

    Surrey

  • Study site

    Swansea

  • Study site

    Wolverhampton

Other trials in United Kingdom

Poland10 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Gdansk

  • Study site

    Kutno

  • Study site

    Lodz

  • Study site

    Poznan

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Russia10 sites

  • Study site

    Barnaul

  • Study site

    Ivanovo

  • Study site

    Moscow

  • Study site

    Obninsk

  • Study site

    Omsk

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Ufa

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

Israel7 sites

  • Study site

    Haifa

  • Study site

    Jeruselem

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

  • Study site

    Tsrifin

Other trials in Israel

Belgium6 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Kortrijk

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Ottignies

Other trials in Belgium

Netherlands6 sites

  • Study site

    Alkmaar

  • Study site

    Eindhoven

  • Study site

    Hoofddorp

  • Study site

    Leidschendam

  • Study site

    Nijmegen

  • Study site

    Rotterdam

Other trials in Netherlands

New Zealand6 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Hamilton

  • Study site

    Nelson

  • Study site

    Tauranga

  • Study site

    Whangarei

Other trials in New Zealand

Czechia5 sites

  • Study site

    Liberec

  • Study site

    Olomouc

  • Study site

    Opava

  • Study site

    Pilsen

  • Study site

    Prague

Other trials in Czechia

Finland5 sites

  • Study site

    Helsinki

  • Study site

    Oulu

  • Study site

    Seinäjoki

  • Study site

    Tampere

  • Study site

    Turku

Other trials in Finland

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Miskolc

  • Study site

    Nyíregyhá

  • Study site

    Sopron

  • Study site

    Szentes

Other trials in Hungary

Romania5 sites

  • Study site

    Baia Mare

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Târgu Mureş

Other trials in Romania

Slovakia5 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Martin

  • Study site

    Nitra

  • Study site

    Trenčín

Other trials in Slovakia

South Korea5 sites

  • Study site

    Daegu

  • Study site

    Gwangju

  • Study site

    Pusan

  • Study site

    Seongnam

  • Study site

    Seoul

Other trials in South Korea

Sweden5 sites

  • Study site

    Gothenburg

  • Study site

    Örebro

  • Study site

    Stockholm

  • Study site

    Umeå

  • Study site

    Uppsala

Other trials in Sweden

Austria4 sites

  • Study site

    Graz

  • Study site

    Innsbruck

  • Study site

    Linz

  • Study site

    Vienna

Other trials in Austria

Denmark4 sites

  • Study site

    Aalborg C

  • Study site

    Copenhagen

  • Study site

    Odense

  • Study site

    Roskilde

Other trials in Denmark

Taiwan4 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Taipei

  • Study site

    Taoyuan County

Other trials in Taiwan

Norway1 site

  • Study site

    Nordbyhagen

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
Apalutamide, Placebo
Keywords
Prostate neoplasms, Prostate cancer, Castration-resistant prostate cancer, Non-metastatic castration-resistant prostate cancer, ARN-509, Apalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApalutamideDrug

    240 mg tablets administered by mouth on a continuous once daily dosing regimen

  • PlaceboDrug

    Matched placebo tablets administered by mouth on a continuous once daily dosing regimen

Study groups in NCT01946204
Study groupRoleWhat they receive
Treatment Arm A: ApalutamideExperimentalNot described
Receives: Drug: Apalutamide
Treatment Arm B: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 43 Months

Secondary outcomes (5)

  1. Time to Metastasis (TTM)

    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.

    Measured: Up to approximately 43 Months

  2. Progression-free Survival (PFS)

    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.

    Measured: Up to approximately 43 Months

  3. Time to Symptomatic Progression

    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.

    Measured: Up to approximately 43 Months

  4. Overall Survival

    Overall survival was defined as the time from randomization to the date of death due to any cause.

    Measured: Up to approximately 43 months

  5. Time to Initiation of Cytotoxic Chemotherapy

    Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.

    Measured: Up to approximately 43 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2013 (estimated)
  2. Study start14 Oct 2013
  3. Primary completion19 May 2017
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01946204
Sponsor's protocol ID
CR102931
Other IDs
ARN-509-003; 56021927PCR1007, 2012-004322-24
Acronym
SPARTAN
Status last verified
Sep 2026
First submitted
17 Sep 2013
Last updated
28 Sep 2026
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40132221

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide in people with Prostatic Neoplasms, run by Aragon Pharmaceuticals, Inc. at 379 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 379 sites in United States, Germany, Japan, Canada, France and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR) (time frame: Up to approximately 43 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01946204, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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