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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02257736
Registration number
NCT02257736
Ethics application status
Date submitted
2/10/2014
Date registered
6/10/2014
Date last updated
24/05/2024
Titles & IDs
Public title
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
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Scientific title
A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
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Secondary ID [1]
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56021927PCR3001
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Secondary ID [2]
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CR105505
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Universal Trial Number (UTN)
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Trial acronym
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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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Condition category
Condition code
Cancer
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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 - Abiraterone acetate
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo
Experimental: Group 1: AAP and apalutamide - Participants will receive apalutamide 240 milligram (mg) (4*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).
Placebo Comparator: Group 2: AAP and Placebo - Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).
Treatment: Drugs: Apalutamide
Participants will receive 240 mg (4*60 mg tablets) of apalutamide once daily orally.
Treatment: Drugs: Abiraterone acetate
Participants will receive 1000 mg (4*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Treatment: Drugs: Prednisone
Participants will receive 5 mg tablet of prednisone twice daily orally.
Treatment: Drugs: Placebo
Participants will receive matching placebo to apalutamide once daily orally.
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Intervention code [1]
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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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Radiographic Progression-free Survival (rPFS)
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Assessment method [1]
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The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
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Timepoint [1]
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Up to 3 years and 4 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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The OS was defined as the time from randomization to date of death from any cause.
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Timepoint [1]
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Up to 5 years and 10 months
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Secondary outcome [2]
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Time to Chronic Opioid Use
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Assessment method [2]
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Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use.
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Timepoint [2]
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Up to 5 years and 10 months
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Secondary outcome [3]
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Time to Initiation of Cytotoxic Chemotherapy
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Assessment method [3]
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Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.
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Timepoint [3]
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Up to 5 years and 10 months
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Secondary outcome [4]
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Time to Pain Progression
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Assessment method [4]
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Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations >=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, 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.CRF pain refers to participant's response to global pain assessment "How would you rate your pain over the past 7 days?"with a scale of 0("No pain") to 10("Pain as bad as you can imagine"),that is systematically reported and recorded on the eCRF.
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Timepoint [4]
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Up to 5 years and 10 months
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Eligibility
Key inclusion criteria
- Adenocarcinoma of the prostate
- Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic
lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans
(visceral or lymph node disease). If lymph node metastasis is the only evidence of
metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest
diameter
- Castration-resistant prostate cancer demonstrated during continuous androgen
deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the
last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)
- Participants who received a first generation anti-androgen (eg, bicalutamide,
flutamide, nilutamide) must have at least a 6-week washout prior to randomization and
must show continuing disease (PSA) progression (an increase in PSA) after the washout
period
- Prostate cancer progression documented by prostate-specific antigen (PSA) according to
the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression
of soft tissue according to modified Response Evaluation Criteria in Solid Tumors,
version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone
according to PCWG2
- Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP
should still be in the double-blind phase of the study, should be receiving AAP alone
and should have ECOG 0-1-2.
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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
- Small cell or neuroendocrine carcinoma of the prostate
- Known brain metastases
- Prior chemotherapy for prostate cancer, except if administered in the
adjuvant/neoadjuvant setting
- Previously treated with ketoconazole for prostate cancer for greater than 7 days
- Therapies that must be discontinued or substituted at least 4 weeks prior to
randomization include the following: a) Medications known to lower the seizure
threshold, b) Herbal and non-herbal products that may decrease PSA levels (example
[eg], saw palmetto, pomegranate) or c) Any investigational agent
- At Screening need for parenteral or oral opioid analgesics (eg, codeine,
dextropropoxyphene)
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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 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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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
26/11/2014
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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
982
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Recruitment in Australia
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- Adelaide
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- Ashford
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Saint Petersburg
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Country [107]
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Russian Federation
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State/province [107]
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0
Saint-Petersburg,
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Country [108]
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Russian Federation
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State/province [108]
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Saint-Petersburg
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Country [109]
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Russian Federation
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Ufa
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Country [110]
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South Africa
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State/province [110]
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Bloemfontein
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Country [111]
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South Africa
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State/province [111]
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Cape Town
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South Africa
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Johannesburg
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Country [113]
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South Africa
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Pretoria
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Country [114]
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Spain
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State/province [114]
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Alcorcon
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Country [115]
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Spain
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State/province [115]
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Barcelona
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Country [116]
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Spain
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State/province [116]
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Cadiz
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Country [117]
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Spain
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State/province [117]
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Cordoba
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Country [118]
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Spain
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State/province [118]
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Madrid
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Country [119]
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Spain
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San Sebastián de los Reyes
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Country [120]
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Spain
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State/province [120]
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Valencia
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United Kingdom
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Ayr
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Country [122]
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United Kingdom
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State/province [122]
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Belfast
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United Kingdom
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Birmingham
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Country [124]
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United Kingdom
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Edinburgh
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Country [125]
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United Kingdom
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Glasgow
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United Kingdom
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London
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Country [127]
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United Kingdom
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Manchester
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Country [128]
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United Kingdom
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State/province [128]
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Plymouth
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United Kingdom
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Preston
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United Kingdom
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Stevenage
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United Kingdom
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Sutton
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United Kingdom
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State/province [132]
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Westcliff on Sea
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United Kingdom
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Aragon Pharmaceuticals, Inc.
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare the radiographic progression-free survival (rPFS) of
apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone
(AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any
chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate
cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of
sperm]).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02257736
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02257736
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