En undersøgelse af Apalutamid (ARN-509) hos mænd med ikke-metastatisk kastrationsresistent prostatakræft (SPARTAN)
24. september 2026 opdateret af: Aragon Pharmaceuticals, Inc.
Et multicenter, randomiseret, dobbeltblindt, placebokontrolleret, fase III-studie af ARN-509 hos mænd med ikke-metastatisk (M0) kastrationsresistent prostatacancer
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.
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
1207
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Adelaide, Australien
-
Box Hill, Australien
-
Camperdown, Australien
-
Darlinghurst, Australien
-
Geelong, Australien
-
Gosford, Australien
-
Hobart, Australien
-
Kogarah, Australien
-
Liverpool, Australien
-
Melbourne, Australien
-
Nedlands, Australien
-
Parkville, Australien
-
South Woodville, Australien
-
Southport, Australien
-
Sydney, Australien
-
Tweed Heads, Australien
-
Wollongong, Australien
-
-
-
-
-
Brussels, Belgien
-
Ghent, Belgien
-
Kortrijk, Belgien
-
Leuven, Belgien
-
Liège, Belgien
-
Ottignies, Belgien
-
-
-
-
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
-
-
-
-
-
Aalborg C, Danmark
-
Copenhagen, Danmark
-
Odense, Danmark
-
Roskilde, Danmark
-
-
-
-
-
Blackburn, Det Forenede Kongerige
-
Cambridge, Det Forenede Kongerige
-
Cardiff, Det Forenede Kongerige
-
Dundee, Det Forenede Kongerige
-
Glasgow, Det Forenede Kongerige
-
Guildford, Det Forenede Kongerige
-
Leeds, Det Forenede Kongerige
-
London, Det Forenede Kongerige
-
Maidstone, Det Forenede Kongerige
-
Metropolitan Borough of Wirral, Det Forenede Kongerige
-
Nottingham, Det Forenede Kongerige
-
Plymouth, Det Forenede Kongerige
-
Southampton, Det Forenede Kongerige
-
Surrey, Det Forenede Kongerige
-
Swansea, Det Forenede Kongerige
-
Wolverhampton, Det Forenede Kongerige
-
-
-
-
-
Helsinki, Finland
-
Oulu, Finland
-
Seinäjoki, Finland
-
Tampere, Finland
-
Turku, Finland
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater
-
-
Alaska
-
Anchorage, Alaska, Forenede Stater
-
-
Arizona
-
Chandler, Arizona, Forenede Stater
-
Tucson, Arizona, Forenede Stater
-
-
California
-
Duarte, California, Forenede Stater
-
Fullerton, California, Forenede Stater
-
Laguna Woods, California, Forenede Stater
-
Los Angeles, California, Forenede Stater
-
Orange, California, Forenede Stater
-
Roseville, California, Forenede Stater
-
Sacramento, California, Forenede Stater
-
San Bernardino, California, Forenede Stater
-
San Diego, California, Forenede Stater
-
San Francisco, California, Forenede Stater
-
Santa Monica, California, Forenede Stater
-
Sherman Oaks, California, Forenede Stater
-
Stanford, California, Forenede Stater
-
Tarzana, California, Forenede Stater
-
Torrance, California, Forenede Stater
-
-
Colorado
-
Denver, Colorado, Forenede Stater
-
Englewood, Colorado, Forenede Stater
-
Glenwood Springs, Colorado, Forenede Stater
-
Grand Junction, Colorado, Forenede Stater
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater
-
-
Florida
-
Aventura, Florida, Forenede Stater
-
Boca Raton, Florida, Forenede Stater
-
Bradenton, Florida, Forenede Stater
-
Daytona Beach, Florida, Forenede Stater
-
Fort Myers, Florida, Forenede Stater
-
Hialeah, Florida, Forenede Stater
-
Jacksonville, Florida, Forenede Stater
-
Miami, Florida, Forenede Stater
-
New Port Richey, Florida, Forenede Stater
-
Orlando, Florida, Forenede Stater
-
Sarasota, Florida, Forenede Stater
-
St. Petersburg, Florida, Forenede Stater
-
Wellington, Florida, Forenede Stater
-
-
Idaho
-
Meridian, Idaho, Forenede Stater
-
-
Illinois
-
Chicago, Illinois, Forenede Stater
-
Decatur, Illinois, Forenede Stater
-
Maywood, Illinois, Forenede Stater
-
Melrose Park, Illinois, Forenede Stater
-
-
Indiana
-
Carmel, Indiana, Forenede Stater
-
Jeffersonville, Indiana, Forenede Stater
-
Muncie, Indiana, Forenede Stater
-
-
Iowa
-
West Des Moines, Iowa, Forenede Stater
-
-
Kansas
-
Westwood, Kansas, Forenede Stater
-
Wichita, Kansas, Forenede Stater
-
-
Louisiana
-
Metairie, Louisiana, Forenede Stater
-
New Orleans, Louisiana, Forenede Stater
-
-
Maryland
-
Annapolis, Maryland, Forenede Stater
-
Baltimore, Maryland, Forenede Stater
-
Rockville, Maryland, Forenede Stater
-
Towson, Maryland, Forenede Stater
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater
-
-
Michigan
-
Detroit, Michigan, Forenede Stater
-
Lansing, Michigan, Forenede Stater
-
Minneapolis, Michigan, Forenede Stater
-
Royal Oak, Michigan, Forenede Stater
-
-
Minnesota
-
Duluth, Minnesota, Forenede Stater
-
-
Mississippi
-
Bay Saint Louis, Mississippi, Forenede Stater
-
Southaven, Mississippi, Forenede Stater
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater
-
-
Montana
-
Missoula, Montana, Forenede Stater
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater
-
-
New Hampshire
-
Hooksett, New Hampshire, Forenede Stater
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater
-
Lawrenceville, New Jersey, Forenede Stater
-
Morristown, New Jersey, Forenede Stater
-
Mount Laurel, New Jersey, Forenede Stater
-
New Brunswick, New Jersey, Forenede Stater
-
Voorhees Township, New Jersey, Forenede Stater
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater
-
-
New York
-
Albany, New York, Forenede Stater
-
Mineola, New York, Forenede Stater
-
New York, New York, Forenede Stater
-
Oneida, New York, Forenede Stater
-
Poughkeepsie, New York, Forenede Stater
-
Syracuse, New York, Forenede Stater
-
The Bronx, New York, Forenede Stater
-
-
North Carolina
-
Concord, North Carolina, Forenede Stater
-
Greensboro, North Carolina, Forenede Stater
-
Greenville, North Carolina, Forenede Stater
-
Salisbury, North Carolina, Forenede Stater
-
Winston-Salem, North Carolina, Forenede Stater
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater
-
Cleveland, Ohio, Forenede Stater
-
Middleburg Heights, Ohio, Forenede Stater
-
Middletown, Ohio, Forenede Stater
-
-
Oregon
-
Bend, Oregon, Forenede Stater
-
Portland, Oregon, Forenede Stater
-
Tualatin, Oregon, Forenede Stater
-
-
Pennsylvania
-
Bala-Cynwyd, Pennsylvania, Forenede Stater
-
Bryn Mawr, Pennsylvania, Forenede Stater
-
Lancaster, Pennsylvania, Forenede Stater
-
Philadelphia, Pennsylvania, Forenede Stater
-
Pittsburgh, Pennsylvania, Forenede Stater
-
-
Rhode Island
-
Warwick, Rhode Island, Forenede Stater
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater
-
Greenville, South Carolina, Forenede Stater
-
Myrtle Beach, South Carolina, Forenede Stater
-
West Columbia, South Carolina, Forenede Stater
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater
-
Nashville, Tennessee, Forenede Stater
-
-
Texas
-
Abilene, Texas, Forenede Stater
-
Amarillo, Texas, Forenede Stater
-
Dallas, Texas, Forenede Stater
-
Fort Sam Houston, Texas, Forenede Stater
-
Houston, Texas, Forenede Stater
-
McAllen, Texas, Forenede Stater
-
San Antonio, Texas, Forenede Stater
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater
-
Richmond, Virginia, Forenede Stater
-
Virginia Beach, Virginia, Forenede Stater
-
-
Washington
-
Burien, Washington, Forenede Stater
-
Edmonds, Washington, Forenede Stater
-
Seattle, Washington, Forenede Stater
-
Tacoma, Washington, Forenede Stater
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater
-
Madison, Wisconsin, Forenede Stater
-
Milwaukee, Wisconsin, Forenede Stater
-
-
-
-
-
Angers, Frankrig
-
Besançon, Frankrig
-
Bordeaux, Frankrig
-
Caen Cédex 05, Frankrig
-
Clermont-Ferrand, Frankrig
-
Hyers, Frankrig
-
La Roche-sur-Yon, Frankrig
-
Le Mans, Frankrig
-
Lille Cedex N/a, Frankrig
-
Lyon, Frankrig
-
Marseille, Frankrig
-
Nice, Frankrig
-
Nîmes, Frankrig
-
Paris, Frankrig
-
Reims, Frankrig
-
Rennes, Frankrig
-
Rouen, Frankrig
-
Saint-Grégoire, Frankrig
-
Saint-Herblain, Frankrig
-
Strasbourg, Frankrig
-
Suresnes, Frankrig
-
Tours, Frankrig
-
Vandœuvre-lès-Nancy, Frankrig
-
-
-
-
-
Alkmaar, Holland
-
Eindhoven, Holland
-
Hoofddorp, Holland
-
Leidschendam, Holland
-
Nijmegen, Holland
-
Rotterdam, Holland
-
-
-
-
-
Haifa, Israel
-
Jeruselem, Israel
-
Kfar Saba, Israel
-
Petah Tikva, Israel
-
Ramat Gan, Israel
-
Tel Aviv, Israel
-
Tsrifin, Israel
-
-
-
-
-
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
-
-
-
-
-
Auckland, New Zealand
-
Christchurch, New Zealand
-
Hamilton, New Zealand
-
Nelson, New Zealand
-
Tauranga, New Zealand
-
Whangarei, New Zealand
-
-
-
-
-
Nordbyhagen, Norge
-
-
-
-
-
Bialystok, Polen
-
Bydgoszcz, Polen
-
Gdansk, Polen
-
Kutno, Polen
-
Lodz, Polen
-
Poznan, Polen
-
Szczecin, Polen
-
Torun, Polen
-
Warsaw, Polen
-
Wroclaw, Polen
-
-
-
-
-
Baia Mare, Rumænien
-
Brasov, Rumænien
-
Bucharest, Rumænien
-
Cluj-Napoca, Rumænien
-
Târgu Mureş, Rumænien
-
-
-
-
-
Barnaul, Rusland
-
Ivanovo, Rusland
-
Moscow, Rusland
-
Obninsk, Rusland
-
Omsk, Rusland
-
Ryazan, Rusland
-
Saint Petersburg, Rusland
-
Ufa, Rusland
-
Yaroslavl, Rusland
-
Yekaterinburg, Rusland
-
-
-
-
-
Banská Bystrica, Slovakiet
-
Bratislava, Slovakiet
-
Martin, Slovakiet
-
Nitra, Slovakiet
-
Trenčín, Slovakiet
-
-
-
-
-
A Coruña, Spanien
-
Badalona, Spanien
-
Barcelona, Spanien
-
Castellon, Spanien
-
Girona, Spanien
-
Guadalajara, Spanien
-
Jerez de la Frontera, Spanien
-
Las Palmas de Gran Canaria, Spanien
-
Madrid, Spanien
-
Murcia, Spanien
-
Málaga, Spanien
-
Palma de Mallorca, Spanien
-
Pamplona, Spanien
-
Sabadell, Spanien
-
Salamanca, Spanien
-
San Sebastián de los Reyes, Spanien
-
Santander, Spanien
-
Seville, Spanien
-
Valencia, Spanien
-
-
-
-
-
Gothenburg, Sverige
-
Stockholm, Sverige
-
Umeå, Sverige
-
Uppsala, Sverige
-
Örebro, Sverige
-
-
-
-
-
Daegu, Sydkorea
-
Gwangju, Sydkorea
-
Pusan, Sydkorea
-
Seongnam, Sydkorea
-
Seoul, Sydkorea
-
-
-
-
-
Kaohsiung City, Taiwan
-
Taichung, Taiwan
-
Taipei, Taiwan
-
Taoyuan County, Taiwan
-
-
-
-
-
Liberec, Tjekkiet
-
Olomouc, Tjekkiet
-
Opava, Tjekkiet
-
Pilsen, Tjekkiet
-
Prague, Tjekkiet
-
-
-
-
-
Aachen, Tyskland
-
Bergisch Gladbach, Tyskland
-
Berlin, Tyskland
-
Braunschweig, Tyskland
-
Cologne, Tyskland
-
Duisburg, Tyskland
-
Emmendingen, Tyskland
-
Frankfurt am Main, Tyskland
-
Greifswald, Tyskland
-
Göttingen, Tyskland
-
Hamburg, Tyskland
-
Hanover, Tyskland
-
Heidelberg, Tyskland
-
Heinsberg, Tyskland
-
Homburg/Saar, Tyskland
-
Jena, Tyskland
-
Kiel, Tyskland
-
Kirchheim unter Teck, Tyskland
-
Magdeburg, Tyskland
-
Mainz, Tyskland
-
Mannheim, Tyskland
-
Marburg, Tyskland
-
Mettmann, Tyskland
-
Müllheim, Tyskland
-
Münster, Tyskland
-
Nürtingen, Tyskland
-
Regensburg, Tyskland
-
Rostock, Tyskland
-
Tübingen, Tyskland
-
Weiden, Tyskland
-
Wilhelmshaven, Tyskland
-
Wuppertan, Tyskland
-
Zirndorf, Tyskland
-
-
-
-
-
Budapest, Ungarn
-
Miskolc, Ungarn
-
Nyíregyhá, Ungarn
-
Sopron, Ungarn
-
Szentes, Ungarn
-
-
-
-
-
Graz, Østrig
-
Innsbruck, Østrig
-
Linz, Østrig
-
Vienna, Østrig
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Behandlingsarm A: Apalutamid
|
240 mg tablets administered by mouth on a continuous once daily dosing regimen |
|
Placebo komparator: Behandlingsarm B: Placebo
|
Matched placebo tablets administered by mouth on a continuous once daily dosing regimen |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Metastasis (TTM)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Aragon Pharmaceuticals, Inc. Clinical Trial, Aragon Pharmaceuticals, Inc.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Chowdhury 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.
- Smith 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.
- Saad 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.
- Smith 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.
- Pollock 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.
- Uemura 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.
- Karsh 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.
- Shen 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.
- 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.
- Feng 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.
- Roy 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
14. oktober 2013
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
19. maj 2017
Studieafslutning (Anslået)
Studieafslutning
31. december 2027
Datoer for studieregistrering
Først indsendt
Først indsendt
17. september 2013
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
17. september 2013
Først opslået (Anslået)
Først opslået
19. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
28. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CR102931
- 2012-004322-24 (EudraCT nummer)
- ARN-509-003; 56021927PCR1007 (Anden identifikator: Janssen Research & Development, LLC)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .