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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01946204
Registration number
NCT01946204
Ethics application status
Date submitted
17/09/2013
Date registered
19/09/2013
Date last updated
15/08/2024
Titles & IDs
Public title
A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer
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Secondary ID [1]
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0
ARN-509-003
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Secondary ID [2]
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CR102931
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Universal Trial Number (UTN)
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Trial acronym
SPARTAN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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0
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Condition category
Condition code
Cancer
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0
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apalutamide
Treatment: Drugs - Placebo
Experimental: Treatment Arm A: Apalutamide -
Placebo comparator: Treatment Arm B: Placebo -
Treatment: Drugs: Apalutamide
240 mg tablets administered by mouth on a continuous once daily dosing regimen
Treatment: Drugs: Placebo
Matched placebo tablets administered by mouth on a continuous once daily dosing regimen
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 43 Months
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Secondary outcome [1]
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Time to Metastasis (TTM)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 43 Months
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Secondary outcome [2]
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Progression-free Survival (PFS)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 43 Months
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Secondary outcome [3]
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Time to Symptomatic Progression
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 43 Months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival was defined as the time from randomization to the date of death due to any cause.
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Timepoint [4]
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Up to approximately 43 months
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Secondary outcome [5]
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Time to Initiation of Cytotoxic Chemotherapy
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Assessment method [5]
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Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
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Timepoint [5]
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Up to approximately 43 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
1207
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Recruitment in Australia
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- Adelaide
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- Box Hill
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0
0
Germany
Query!
State/province [102]
0
0
Braunschweig
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Duisburg
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Emmendingen
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Frankfurt / Main
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Greifswald
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Göttingen
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Hamburg
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Hannover
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Heidelberg
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Heinsberg
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Homburg/Saar
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Jena
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Kiel
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Kirchheim unter Teck
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Köln
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Magdeburg
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Mainz
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Mannheim
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Marburg
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Mettmann
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Müllheim
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Münster
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Nuertingen
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Regensburg
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Rostock
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Tübingen
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Weiden
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Wilhelmshaven
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Wuppertan
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Zirndorf
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Budapest
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Miskolc
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Nyíregyhá
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Sopron
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Szentes
Query!
Country [137]
0
0
Israel
Query!
State/province [137]
0
0
Haifa
Query!
Country [138]
0
0
Israel
Query!
State/province [138]
0
0
Jeruselem
Query!
Country [139]
0
0
Israel
Query!
State/province [139]
0
0
Kfar-Saba
Query!
Country [140]
0
0
Israel
Query!
State/province [140]
0
0
Petah-Tikva
Query!
Country [141]
0
0
Israel
Query!
State/province [141]
0
0
Ramat Gan
Query!
Country [142]
0
0
Israel
Query!
State/province [142]
0
0
Tel Aviv
Query!
Country [143]
0
0
Israel
Query!
State/province [143]
0
0
Zerifin
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Akita
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Fukuoka-shi
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Gifu
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Hakodate
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Hiroshima
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Hokkaido
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Kanazawa
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Kashiwa
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Kita-Gun
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Kobe
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Koshigaya
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Kumamoto
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Kurume
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Matsuyama
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Nagano
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Nagasaki
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Nagoya
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Niigata
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Osaka-Sayama
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Osaka
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Sagamihara
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Sakura
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Sapporo
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Shinjuku-Ku
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Tokushima
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Tokyo
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Ube
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Wakayama
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Yokohama
Query!
Country [173]
0
0
Korea, Republic of
Query!
State/province [173]
0
0
Daegu
Query!
Country [174]
0
0
Korea, Republic of
Query!
State/province [174]
0
0
Gwangju-si
Query!
Country [175]
0
0
Korea, Republic of
Query!
State/province [175]
0
0
Pusan
Query!
Country [176]
0
0
Korea, Republic of
Query!
State/province [176]
0
0
Seongnam
Query!
Country [177]
0
0
Korea, Republic of
Query!
State/province [177]
0
0
Seoul
Query!
Country [178]
0
0
Netherlands
Query!
State/province [178]
0
0
Alkmaar
Query!
Country [179]
0
0
Netherlands
Query!
State/province [179]
0
0
Eindhoven
Query!
Country [180]
0
0
Netherlands
Query!
State/province [180]
0
0
Hoofddorp
Query!
Country [181]
0
0
Netherlands
Query!
State/province [181]
0
0
Leidschendam
Query!
Country [182]
0
0
Netherlands
Query!
State/province [182]
0
0
Nijmegen
Query!
Country [183]
0
0
Netherlands
Query!
State/province [183]
0
0
Rotterdam
Query!
Country [184]
0
0
New Zealand
Query!
State/province [184]
0
0
Auckland
Query!
Country [185]
0
0
New Zealand
Query!
State/province [185]
0
0
Christchurch
Query!
Country [186]
0
0
New Zealand
Query!
State/province [186]
0
0
Hamilton
Query!
Country [187]
0
0
New Zealand
Query!
State/province [187]
0
0
Nelson City
Query!
Country [188]
0
0
New Zealand
Query!
State/province [188]
0
0
Tauranga
Query!
Country [189]
0
0
New Zealand
Query!
State/province [189]
0
0
Whangarei
Query!
Country [190]
0
0
Norway
Query!
State/province [190]
0
0
Nordbyhagen
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Bialystok
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Bydgoszcz
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Gdansk
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Kutno
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Lodz
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Poznan
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Szczecin
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Torun
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Warszawa
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Wroclaw
Query!
Country [201]
0
0
Romania
Query!
State/province [201]
0
0
Baia Mare
Query!
Country [202]
0
0
Romania
Query!
State/province [202]
0
0
Brasov
Query!
Country [203]
0
0
Romania
Query!
State/province [203]
0
0
Bucharest
Query!
Country [204]
0
0
Romania
Query!
State/province [204]
0
0
Cluj- Napoca
Query!
Country [205]
0
0
Romania
Query!
State/province [205]
0
0
Targu Mures
Query!
Country [206]
0
0
Russian Federation
Query!
State/province [206]
0
0
Barnaul
Query!
Country [207]
0
0
Russian Federation
Query!
State/province [207]
0
0
Ekaterinburg
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Ivanovo
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Moscow
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Obninsk, Kaluga Region
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Omsk
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Ryazan
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Saint Petersburg
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
St. Petersburg
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Ufa
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Yaroslavl
Query!
Country [217]
0
0
Slovakia
Query!
State/province [217]
0
0
Banska Bystrica
Query!
Country [218]
0
0
Slovakia
Query!
State/province [218]
0
0
Bratislava
Query!
Country [219]
0
0
Slovakia
Query!
State/province [219]
0
0
Martin
Query!
Country [220]
0
0
Slovakia
Query!
State/province [220]
0
0
Nitra
Query!
Country [221]
0
0
Slovakia
Query!
State/province [221]
0
0
Trencín
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
Badalona
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Barcelona
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Castellon
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
Coruña
Query!
Country [226]
0
0
Spain
Query!
State/province [226]
0
0
Girona
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
Guadalajara
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Jerez de la Frontera
Query!
Country [229]
0
0
Spain
Query!
State/province [229]
0
0
Las Palmas De Gran Canaria
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
Madrid
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Murcia
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Málaga
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Palma de Mallorca
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Pamplona
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Sabadell
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
Salamanca
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
San Sebastian de los Reyes
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
Santander
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Sevilla N/a
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Sevilla
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Valencia
Query!
Country [242]
0
0
Sweden
Query!
State/province [242]
0
0
Goteborg
Query!
Country [243]
0
0
Sweden
Query!
State/province [243]
0
0
Stockholm
Query!
Country [244]
0
0
Sweden
Query!
State/province [244]
0
0
Umea
Query!
Country [245]
0
0
Sweden
Query!
State/province [245]
0
0
Uppsala
Query!
Country [246]
0
0
Sweden
Query!
State/province [246]
0
0
Örebro
Query!
Country [247]
0
0
Taiwan
Query!
State/province [247]
0
0
Kaohsiung
Query!
Country [248]
0
0
Taiwan
Query!
State/province [248]
0
0
Taichung
Query!
Country [249]
0
0
Taiwan
Query!
State/province [249]
0
0
Taipei
Query!
Country [250]
0
0
Taiwan
Query!
State/province [250]
0
0
Taoyuan County
Query!
Country [251]
0
0
United Kingdom
Query!
State/province [251]
0
0
Blackburn
Query!
Country [252]
0
0
United Kingdom
Query!
State/province [252]
0
0
Cambridge
Query!
Country [253]
0
0
United Kingdom
Query!
State/province [253]
0
0
Cardiff
Query!
Country [254]
0
0
United Kingdom
Query!
State/province [254]
0
0
Dundee
Query!
Country [255]
0
0
United Kingdom
Query!
State/province [255]
0
0
Glasgow
Query!
Country [256]
0
0
United Kingdom
Query!
State/province [256]
0
0
Guildford
Query!
Country [257]
0
0
United Kingdom
Query!
State/province [257]
0
0
Leeds
Query!
Country [258]
0
0
United Kingdom
Query!
State/province [258]
0
0
London
Query!
Country [259]
0
0
United Kingdom
Query!
State/province [259]
0
0
Maidstone
Query!
Country [260]
0
0
United Kingdom
Query!
State/province [260]
0
0
Nottingham
Query!
Country [261]
0
0
United Kingdom
Query!
State/province [261]
0
0
Plymouth
Query!
Country [262]
0
0
United Kingdom
Query!
State/province [262]
0
0
Southampton
Query!
Country [263]
0
0
United Kingdom
Query!
State/province [263]
0
0
Surrey
Query!
Country [264]
0
0
United Kingdom
Query!
State/province [264]
0
0
Swansea
Query!
Country [265]
0
0
United Kingdom
Query!
State/province [265]
0
0
Wirral
Query!
Country [266]
0
0
United Kingdom
Query!
State/province [266]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Aragon Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01946204
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Trial related presentations / publications
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. Erratum In: Prostate Cancer Prostatic Dis. 2023 Dec;26(4):813. doi: 10.1038/s41391-023-00683-1. 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. 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. Erratum In: BMC Urol. 2020 Oct 22;20(1):166. doi: 10.1186/s12894-020-00739-7. 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.
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Aragon Pharmaceuticals, Inc. Clinical Trial
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Aragon Pharmaceuticals, Inc.
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/04/NCT01946204/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/04/NCT01946204/SAP_001.pdf
Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT01946204
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