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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02257736




Registration number
NCT02257736
Ethics application status
Date submitted
2/10/2014
Date registered
6/10/2014
Date last updated
20/12/2024

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)
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)
Secondary ID [1] 0 0
56021927PCR3001
Secondary ID [2] 0 0
CR105505
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic 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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [1] 0 0
Up to 3 years and 4 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 5 years and 10 months
Secondary outcome [2] 0 0
Time to Chronic Opioid Use
Timepoint [2] 0 0
Up to 5 years and 10 months
Secondary outcome [3] 0 0
Time to Initiation of Cytotoxic Chemotherapy
Timepoint [3] 0 0
Up to 5 years and 10 months
Secondary outcome [4] 0 0
Time to Pain Progression
Timepoint [4] 0 0
Up to 5 years and 10 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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)

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
Accrual to date
Final
982
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Ashford
Recruitment hospital [3] 0 0
- Camperdown
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- Herston
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- Liverpool
Recruitment hospital [6] 0 0
- Malvern
Recruitment hospital [7] 0 0
- Melbourne
Recruitment hospital [8] 0 0
- Southport
Recruitment hospital [9] 0 0
- Wahroonga
Recruitment hospital [10] 0 0
- West Heidelberg
Recruitment hospital [11] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Ashford
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- Camperdown
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- Herston
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- Liverpool
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- Malvern
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- Melbourne
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- Southport
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- Wahroonga
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- West Heidelberg
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- Woolloongabba
Recruitment outside Australia
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Sutton
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Westcliff on Sea
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aragon Pharmaceuticals, Inc.
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02257736