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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01715285




Registration number
NCT01715285
Ethics application status
Date submitted
24/10/2012
Date registered
26/10/2012
Date last updated
13/03/2023

Titles & IDs
Public title
A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
Scientific title
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Secondary ID [1] 0 0
212082PCR3011
Secondary ID [2] 0 0
CR100900
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone
Other interventions - Androgen deprivation therapy (ADT)
Treatment: Drugs - Abiraterone acetate Placebo
Treatment: Drugs - Prednisone Placebo

Experimental: Abiraterone acetate + Prednisone + ADT - Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.

Placebo comparator: Placebo + Androgen Deprivation Therapy (ADT) - Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.


Treatment: Drugs: Abiraterone acetate
Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.

Treatment: Drugs: Prednisone
Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

Other interventions: Androgen deprivation therapy (ADT)
All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.

Treatment: Drugs: Abiraterone acetate Placebo
Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

Treatment: Drugs: Prednisone Placebo
Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 44 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 66 months
Secondary outcome [1] 0 0
Time to Initiation of Chemotherapy
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [2] 0 0
Time to Subsequent Therapy for Prostate Cancer
Timepoint [2] 0 0
Up to 66 months
Secondary outcome [3] 0 0
Time to Pain Progression
Timepoint [3] 0 0
Up to 66 months
Secondary outcome [4] 0 0
Time to Skeletal-Related Event
Timepoint [4] 0 0
Up to 66 months
Secondary outcome [5] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [5] 0 0
Up to 66 months

Eligibility
Key inclusion criteria
* Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan
* At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2
* Adequate hematologic, hepatic, and renal function
* Agrees to protocol-defined use of effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Active infection or other medical condition that would make prednisone use contraindicated
* Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day
* Pathological finding consistent with small cell carcinoma of the prostate
* Known brain metastasis
* Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/02/2022
Sample size
Target
Accrual to date
Final
1209
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Footscray
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Malvern
Recruitment hospital [5] 0 0
- Randwick
Recruitment hospital [6] 0 0
- Wahroonga
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Footscray
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment postcode(s) [6] 0 0
- Wahroonga
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
State/province [2] 0 0
Cordoba
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Argentina
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La Rioja
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Argentina
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Rosario
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Belgium
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Antwerpen
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Belgium
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Bonheiden
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Belgium
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Brasschaat
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Liège
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Belgium
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Namur
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Belgium
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Ottignies
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Belgium
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Sint-Niklaas
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Belgium
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Yvoir
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Brazil
State/province [15] 0 0
Barretos
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Brazil
State/province [16] 0 0
Belo Horizonte
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Brazil
State/province [17] 0 0
Caxias Do Sul
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Brazil
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Curitiba
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Brazil
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Ijui
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Brazil
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Jau
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Brazil
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Natal
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Brazil
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Novo Hamburgo
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Sao Jose Do Rio Preto
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Brazil
State/province [28] 0 0
Sao Paulo
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Gabrovo
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Manitoba
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Canada
State/province [35] 0 0
Hamilton
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Canada
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Toronto
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Canada
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Vancouver
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Chile
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Santiago
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China
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Beijing
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China
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Chengdu
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China
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Chongqing
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China
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Guangzhou
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China
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Hangzhou
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China
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Nanjing
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China
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Shanghai
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China
State/province [46] 0 0
Su Zhou
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China
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Tianjin
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China
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Wuhan
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Colombia
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Bogota
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Colombia
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Floridablanca
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Colombia
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Medellin
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Czechia
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Hradec Kralove
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Czechia
State/province [53] 0 0
Olomouc
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Czechia
State/province [54] 0 0
Plzen
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Czechia
State/province [55] 0 0
Praha 10
Country [56] 0 0
Czechia
State/province [56] 0 0
Praha 2
Country [57] 0 0
Czechia
State/province [57] 0 0
Praha 4
Country [58] 0 0
Denmark
State/province [58] 0 0
Aarhus N.
Country [59] 0 0
Denmark
State/province [59] 0 0
Holsterbro
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Denmark
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Odense N/a
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Denmark
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Roskilde
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Denmark
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Vejle
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Finland
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Oulu
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Finland
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Tampere
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France
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La Chaussee St Victor
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France
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Lille
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France
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Montpellier
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France
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Paris Cedex 14
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France
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Suresnes
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France
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Toulouse
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France
State/province [71] 0 0
Villejuif Cedex
Country [72] 0 0
Germany
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Düsseldorf
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Germany
State/province [73] 0 0
Hamburg
Country [74] 0 0
Germany
State/province [74] 0 0
Nürtingen
Country [75] 0 0
Hungary
State/province [75] 0 0
Budapest N/a
Country [76] 0 0
Hungary
State/province [76] 0 0
Budapest
Country [77] 0 0
Hungary
State/province [77] 0 0
Gyor
Country [78] 0 0
Hungary
State/province [78] 0 0
Miskolc
Country [79] 0 0
Hungary
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Pecs
Country [80] 0 0
Hungary
State/province [80] 0 0
Szentes
Country [81] 0 0
Israel
State/province [81] 0 0
Beer Yaakov
Country [82] 0 0
Israel
State/province [82] 0 0
Beer-Sheva
Country [83] 0 0
Israel
State/province [83] 0 0
Haifa
Country [84] 0 0
Israel
State/province [84] 0 0
Jerusalem
Country [85] 0 0
Israel
State/province [85] 0 0
Kfar Saba
Country [86] 0 0
Israel
State/province [86] 0 0
Petah-Tikva
Country [87] 0 0
Israel
State/province [87] 0 0
Ramat Gan
Country [88] 0 0
Japan
State/province [88] 0 0
Chiba
Country [89] 0 0
Japan
State/province [89] 0 0
Gifu
Country [90] 0 0
Japan
State/province [90] 0 0
Kashiwa
Country [91] 0 0
Japan
State/province [91] 0 0
Matsuyama
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State/province [92] 0 0
Nankoku
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Japan
State/province [93] 0 0
Osaka-Sayama
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Japan
State/province [94] 0 0
Sakura
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Japan
State/province [95] 0 0
Tokushima
Country [96] 0 0
Japan
State/province [96] 0 0
Tokyo
Country [97] 0 0
Japan
State/province [97] 0 0
Ube
Country [98] 0 0
Japan
State/province [98] 0 0
Yokohama
Country [99] 0 0
Japan
State/province [99] 0 0
Yufu
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Bucheon-Si
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Busan
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Korea, Republic of
State/province [102] 0 0
Daegu
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Korea, Republic of
State/province [103] 0 0
Daejeon
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Gyeonggi-do
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Seoul
Country [106] 0 0
Malaysia
State/province [106] 0 0
Kuala Lumpur
Country [107] 0 0
Malaysia
State/province [107] 0 0
Kuching
Country [108] 0 0
Mexico
State/province [108] 0 0
Chihuahua
Country [109] 0 0
Mexico
State/province [109] 0 0
Cuernavaca
Country [110] 0 0
Mexico
State/province [110] 0 0
Durango
Country [111] 0 0
Mexico
State/province [111] 0 0
Guadalajara
Country [112] 0 0
Mexico
State/province [112] 0 0
Monterrey
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Mexico
State/province [113] 0 0
Oaxaca
Country [114] 0 0
Mexico
State/province [114] 0 0
Pachuca de Soto
Country [115] 0 0
Mexico
State/province [115] 0 0
Zapopan
Country [116] 0 0
Netherlands
State/province [116] 0 0
Alkmaar
Country [117] 0 0
Netherlands
State/province [117] 0 0
Amsterdam Zuidoost
Country [118] 0 0
Netherlands
State/province [118] 0 0
Amsterdam
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Netherlands
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Hilversum
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Netherlands
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Hoofddorp
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Netherlands
State/province [121] 0 0
Nieuwegein
Country [122] 0 0
Netherlands
State/province [122] 0 0
Rotterdam
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
State/province [125] 0 0
Hamilton
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New Zealand
State/province [126] 0 0
Tauranga
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Poland
State/province [127] 0 0
Bydgoszcz
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Poland
State/province [128] 0 0
Gdansk
Country [129] 0 0
Poland
State/province [129] 0 0
Lodz
Country [130] 0 0
Poland
State/province [130] 0 0
Lublin
Country [131] 0 0
Poland
State/province [131] 0 0
Warszawa
Country [132] 0 0
Portugal
State/province [132] 0 0
Braga
Country [133] 0 0
Portugal
State/province [133] 0 0
Coimbra
Country [134] 0 0
Portugal
State/province [134] 0 0
Lisboa
Country [135] 0 0
Portugal
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Porto
Country [136] 0 0
Romania
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Brasov
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Romania
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Iasi
Country [141] 0 0
Russian Federation
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Chelyabinsk
Country [142] 0 0
Russian Federation
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Ekaterinburg
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Russian Federation
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Ivanovo
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Obninsk, Kaluga Region
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Russian Federation
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Omsk
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Russian Federation
State/province [149] 0 0
Orenburg
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Russian Federation
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Pyatigorsk
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Ryazan
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Saransk
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Russian Federation
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Saratov
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Russian Federation
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Sochi
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Russian Federation
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St.-Petersburg
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Russian Federation
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Stavropol
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Russian Federation
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Tumen
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Russian Federation
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Ufa
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Russian Federation
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Volgograd
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Russian Federation
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Yoshkar-Ola
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Slovakia
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Košice-Šaca
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Slovakia
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Martin
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Piestany
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Slovakia
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Prešov
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Slovakia
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Rimavska Sobota
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Pretoria
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Spain
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Madrid N/a
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Spain
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Madrid
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Spain
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Murcia N/a
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Sweden
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Göteborg
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Sweden
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Malmö
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Sweden
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Stockholm
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Izmir
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Turkey
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Zonguldak
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Ukraine
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Cherkassy
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Ukraine
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Dnepropetrovsk
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Ukraine
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Dnipro
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Ukraine
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Khakhiv
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Makiivka
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Ukraine
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Odessa
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Ukraine
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Uzhgorod
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Ukraine
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Zaporizhzhia
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01715285