Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02489318
Registration number
NCT02489318
Ethics application status
Date submitted
1/07/2015
Date registered
3/07/2015
Date last updated
29/08/2024
Titles & IDs
Public title
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Query!
Scientific title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Query!
Secondary ID [1]
0
0
2015-000735-32
Query!
Secondary ID [2]
0
0
CR107614
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TITAN
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Apalutamide
Treatment: Drugs - Placebo
Treatment: Drugs - Androgen Deprivation Therapy (ADT)
Experimental: Apalutamide plus ADT - Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
Experimental: Placebo plus ADT - Participants will receive matching Placebo with ADT.
Treatment: Drugs: Apalutamide
Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
Treatment: Drugs: Placebo
Participants will receive Placebo orally once daily in each 28 day treatment cycles.
Treatment: Drugs: Androgen Deprivation Therapy (ADT)
All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Radiographic Progression-free Survival (rPFS)
Query!
Assessment method [1]
0
0
rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.
Query!
Timepoint [1]
0
0
Up to 35 months
Query!
Primary outcome [2]
0
0
Overall Survival (OS)
Query!
Assessment method [2]
0
0
OS was defined as the time from date of randomization to date of death from any cause.
Query!
Timepoint [2]
0
0
Up to 57 months
Query!
Secondary outcome [1]
0
0
Time to Initiation of Cytotoxic Chemotherapy
Query!
Assessment method [1]
0
0
Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Query!
Timepoint [1]
0
0
Up to 57 months
Query!
Secondary outcome [2]
0
0
Time to Pain Progression
Query!
Assessment method [2]
0
0
Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.
Query!
Timepoint [2]
0
0
Up to 57 months
Query!
Secondary outcome [3]
0
0
Time to Chronic Opioid Use
Query!
Assessment method [3]
0
0
Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (\>=) 3 weeks for oral or \>=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a \>=30 percent (%) increase in total daily dose of the opioid analgesics lasting for \>= 3 weeks for oral or \>= 7 days for non-oral formulation.
Query!
Timepoint [3]
0
0
Up to 57 months
Query!
Secondary outcome [4]
0
0
Time to Skeletal-related Event (SRE)
Query!
Assessment method [4]
0
0
Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.
Query!
Timepoint [4]
0
0
Up to 57 months
Query!
Eligibility
Key inclusion criteria
* Diagnosis of prostate adenocarcinoma as confirmed by the investigator
* Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
* Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
* Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization
* Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
* Known brain metastases
* Lymph nodes as only sites of metastases
* Visceral (ie, liver or lung) metastases as only sites of metastases
* Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
* Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
* History of seizures or medications known to lower seizure threshold
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/11/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
5/09/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1052
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Albury
Query!
Recruitment hospital [2]
0
0
- Elizabeth Vale
Query!
Recruitment hospital [3]
0
0
- Kogarah
Query!
Recruitment hospital [4]
0
0
- Port Macquarie
Query!
Recruitment hospital [5]
0
0
- South Brisbane
Query!
Recruitment hospital [6]
0
0
- St Leonards
Query!
Recruitment postcode(s) [1]
0
0
- Albury
Query!
Recruitment postcode(s) [2]
0
0
- Elizabeth Vale
Query!
Recruitment postcode(s) [3]
0
0
- Kogarah
Query!
Recruitment postcode(s) [4]
0
0
- Port Macquarie
Query!
Recruitment postcode(s) [5]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [6]
0
0
- St Leonards
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nevada
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oregon
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Washington
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Wisconsin
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Berazategui
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
C.a.b.a.
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Capital Federal
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Ciudad Automoma Buenos Aires
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Ciudad De Buenos Aires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Cordoba
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
La Plata
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Pergamino
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Rosario
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
San Miguel de Tucuman
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
San Salvador de Jujuy
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Barretos
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Florianopolis
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Goiania
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Ijui
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Natal
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Ribeirao Preto
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Rio de Janeiro
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Salvador
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Santo Andre
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Sao Paulo
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Sorocaba
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
São Paulo
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Alberta
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
British Columbia
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Ontario
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Quebec
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Beijing
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
ChengDu
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
ChongQing
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Fuzhou
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Guangzhou
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Hangzhou
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
NanJing
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
ShangHai
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Suzhou
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
WuHan
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Wuxi
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Xi'An
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Hradec Králove
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Liberec
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Nový Jicin
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Olomouc
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Opava
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Pardubice
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Praha 10
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Praha 2
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Praha 4
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Praha 5
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Praha 8
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Zlin
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Clermont Ferrand
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Montpellier
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Nancy
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Paris
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Pierre Bénite
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Strasbourg
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Suresnes
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Bonn
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Braunschweig
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Hamburg
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Hannover
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Leipzig
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Lubeck
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Lutherstadt Eisleben
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Nürtingen
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Sindelfingen
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Straubing
Query!
Country [95]
0
0
Hungary
Query!
State/province [95]
0
0
Budapest
Query!
Country [96]
0
0
Hungary
Query!
State/province [96]
0
0
Gyor
Query!
Country [97]
0
0
Hungary
Query!
State/province [97]
0
0
Pécs
Query!
Country [98]
0
0
Hungary
Query!
State/province [98]
0
0
Sopron
Query!
Country [99]
0
0
Israel
Query!
State/province [99]
0
0
Beer Sheva
Query!
Country [100]
0
0
Israel
Query!
State/province [100]
0
0
Haifa
Query!
Country [101]
0
0
Israel
Query!
State/province [101]
0
0
Holon
Query!
Country [102]
0
0
Israel
Query!
State/province [102]
0
0
Kfar Saba
Query!
Country [103]
0
0
Israel
Query!
State/province [103]
0
0
Petach Tikva
Query!
Country [104]
0
0
Israel
Query!
State/province [104]
0
0
Ramat Gan
Query!
Country [105]
0
0
Israel
Query!
State/province [105]
0
0
Zrifin
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Chuo-ku, Chiba-City,
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Hakata-Ku
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Koshigaya
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Matsuyama
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Minami-Ku, Sagamihara-Shi
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Miyazaki
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Nagano-shi
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Nagasaki-shi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Osaka City
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Osaka Sayama shi
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Sakura
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Sapporo
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Yokohama
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Yufu
Query!
Country [120]
0
0
Korea, Republic of
Query!
State/province [120]
0
0
Daegu
Query!
Country [121]
0
0
Korea, Republic of
Query!
State/province [121]
0
0
Daejeon
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Goyang-Si
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Jeollanam-do
Query!
Country [124]
0
0
Korea, Republic of
Query!
State/province [124]
0
0
Seongnam-si
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Seoul
Query!
Country [126]
0
0
Mexico
Query!
State/province [126]
0
0
Ciudad de México
Query!
Country [127]
0
0
Mexico
Query!
State/province [127]
0
0
Durango
Query!
Country [128]
0
0
Mexico
Query!
State/province [128]
0
0
Guadalajara
Query!
Country [129]
0
0
Mexico
Query!
State/province [129]
0
0
Leon
Query!
Country [130]
0
0
Mexico
Query!
State/province [130]
0
0
Mexico City
Query!
Country [131]
0
0
Mexico
Query!
State/province [131]
0
0
Mexico
Query!
Country [132]
0
0
Mexico
Query!
State/province [132]
0
0
Morelia
Query!
Country [133]
0
0
Mexico
Query!
State/province [133]
0
0
Zapopan
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Bialystok
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Bydgoszcz
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Krakow
Query!
Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Kutno
Query!
Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Lodz
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Lublin
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Siedlce
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Sochaczew
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Warszawa
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Wroclaw
Query!
Country [144]
0
0
Romania
Query!
State/province [144]
0
0
Bucharest
Query!
Country [145]
0
0
Romania
Query!
State/province [145]
0
0
Cluj Napoca
Query!
Country [146]
0
0
Romania
Query!
State/province [146]
0
0
Craiova
Query!
Country [147]
0
0
Romania
Query!
State/province [147]
0
0
Targu Mures
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
Barnaul
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
Ivanovo
Query!
Country [150]
0
0
Russian Federation
Query!
State/province [150]
0
0
Moscow
Query!
Country [151]
0
0
Russian Federation
Query!
State/province [151]
0
0
Nizhny Novgorod
Query!
Country [152]
0
0
Russian Federation
Query!
State/province [152]
0
0
Obninsk
Query!
Country [153]
0
0
Russian Federation
Query!
State/province [153]
0
0
Omsk
Query!
Country [154]
0
0
Russian Federation
Query!
State/province [154]
0
0
Pyatigorsk
Query!
Country [155]
0
0
Russian Federation
Query!
State/province [155]
0
0
Rostov-on-Don
Query!
Country [156]
0
0
Russian Federation
Query!
State/province [156]
0
0
Ryazan
Query!
Country [157]
0
0
Russian Federation
Query!
State/province [157]
0
0
Saint-Petersburg
Query!
Country [158]
0
0
Russian Federation
Query!
State/province [158]
0
0
Saransk
Query!
Country [159]
0
0
Russian Federation
Query!
State/province [159]
0
0
Sochi
Query!
Country [160]
0
0
Russian Federation
Query!
State/province [160]
0
0
St Petersburg
Query!
Country [161]
0
0
Russian Federation
Query!
State/province [161]
0
0
Tambov
Query!
Country [162]
0
0
Russian Federation
Query!
State/province [162]
0
0
Tomsk
Query!
Country [163]
0
0
Russian Federation
Query!
State/province [163]
0
0
Tyumen
Query!
Country [164]
0
0
Russian Federation
Query!
State/province [164]
0
0
Ufa
Query!
Country [165]
0
0
Russian Federation
Query!
State/province [165]
0
0
Vologda
Query!
Country [166]
0
0
Spain
Query!
State/province [166]
0
0
Barcelona
Query!
Country [167]
0
0
Spain
Query!
State/province [167]
0
0
Cordoba
Query!
Country [168]
0
0
Spain
Query!
State/province [168]
0
0
Jerez de la Frontera
Query!
Country [169]
0
0
Spain
Query!
State/province [169]
0
0
Madrid
Query!
Country [170]
0
0
Spain
Query!
State/province [170]
0
0
Pamplona
Query!
Country [171]
0
0
Sweden
Query!
State/province [171]
0
0
Göteborg
Query!
Country [172]
0
0
Sweden
Query!
State/province [172]
0
0
Malmö
Query!
Country [173]
0
0
Sweden
Query!
State/province [173]
0
0
Stockholm
Query!
Country [174]
0
0
Sweden
Query!
State/province [174]
0
0
Umeå
Query!
Country [175]
0
0
Sweden
Query!
State/province [175]
0
0
Uppsala
Query!
Country [176]
0
0
Sweden
Query!
State/province [176]
0
0
Växjö
Query!
Country [177]
0
0
Sweden
Query!
State/province [177]
0
0
Örebro
Query!
Country [178]
0
0
Turkey
Query!
State/province [178]
0
0
Ankara
Query!
Country [179]
0
0
Turkey
Query!
State/province [179]
0
0
Edirne
Query!
Country [180]
0
0
Turkey
Query!
State/province [180]
0
0
Istanbul
Query!
Country [181]
0
0
Turkey
Query!
State/province [181]
0
0
Izmir
Query!
Country [182]
0
0
Turkey
Query!
State/province [182]
0
0
Mersin
Query!
Country [183]
0
0
Ukraine
Query!
State/province [183]
0
0
Cherkasy
Query!
Country [184]
0
0
Ukraine
Query!
State/province [184]
0
0
Dnipo
Query!
Country [185]
0
0
Ukraine
Query!
State/province [185]
0
0
Dnipro
Query!
Country [186]
0
0
Ukraine
Query!
State/province [186]
0
0
Ivano-Frankivsk
Query!
Country [187]
0
0
Ukraine
Query!
State/province [187]
0
0
Khakhiv
Query!
Country [188]
0
0
Ukraine
Query!
State/province [188]
0
0
Kharkiv
Query!
Country [189]
0
0
Ukraine
Query!
State/province [189]
0
0
Khmelnytsky
Query!
Country [190]
0
0
Ukraine
Query!
State/province [190]
0
0
Kyiv
Query!
Country [191]
0
0
Ukraine
Query!
State/province [191]
0
0
Lviv
Query!
Country [192]
0
0
Ukraine
Query!
State/province [192]
0
0
Odesa
Query!
Country [193]
0
0
Ukraine
Query!
State/province [193]
0
0
Poltava
Query!
Country [194]
0
0
Ukraine
Query!
State/province [194]
0
0
Uzhgorod
Query!
Country [195]
0
0
Ukraine
Query!
State/province [195]
0
0
Vinnitsa
Query!
Country [196]
0
0
Ukraine
Query!
State/province [196]
0
0
Zaporizhzhya
Query!
Country [197]
0
0
United Kingdom
Query!
State/province [197]
0
0
Carlisle
Query!
Country [198]
0
0
United Kingdom
Query!
State/province [198]
0
0
Dundee
Query!
Country [199]
0
0
United Kingdom
Query!
State/province [199]
0
0
Glasgow
Query!
Country [200]
0
0
United Kingdom
Query!
State/province [200]
0
0
London
Query!
Country [201]
0
0
United Kingdom
Query!
State/province [201]
0
0
Newcastle Upon Tyne
Query!
Country [202]
0
0
United Kingdom
Query!
State/province [202]
0
0
Oxford
Query!
Country [203]
0
0
United Kingdom
Query!
State/province [203]
0
0
Plymouth
Query!
Country [204]
0
0
United Kingdom
Query!
State/province [204]
0
0
Scunthorpe
Query!
Country [205]
0
0
United Kingdom
Query!
State/province [205]
0
0
Stockton on Tees
Query!
Country [206]
0
0
United Kingdom
Query!
State/province [206]
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 determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02489318
Query!
Trial related presentations / publications
Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Basch E, Miladinovic B, Lopez-Gitlitz A, Chi KN. Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study. J Urol. 2021 Oct;206(4):914-923. doi: 10.1097/JU.0000000000001841. Epub 2021 May 27. Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29. 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. Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29. Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez Soto A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/18/NCT02489318/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/18/NCT02489318/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02489318
Download to PDF