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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02257736
Ethics application status
Date submitted
2/10/2014
Date registered
6/10/2014
Date last updated
14/04/2020

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). - Radiographic progression of bone is determined if there are more than or equal (>=) to 2 new lesions if less than (<) 12 weeks from randomization and there are 2 additional new lesions when observed 6 weeks later or, >= 2 new lesions after more than 12 weeks from randomization and the same is confirmed 6 weeks later or, progression of soft tissue lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Timepoint [1] 0 0
Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years
Secondary outcome [1] 0 0
Overall Survival (OS) - The OS is defined as the time from randomization to date of death from any cause.
Timepoint [1] 0 0
Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years
Secondary outcome [2] 0 0
Time to Chronic Opioid Use - Time to chronic opioid use is defined as the time from date of randomization to the first date of opioid use.
Timepoint [2] 0 0
Baseline up to 5 years
Secondary outcome [3] 0 0
Time to Initiation of Cytotoxic Chemotherapy - Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.
Timepoint [3] 0 0
Baseline up to 5 years
Secondary outcome [4] 0 0
Time to Pain Progression - Time to pain progression is defined as time from randomization to progression in worst pain over the last 24 hours (item 3) in the Brief pain inventory-short form (BPI-SF). BPI-SF is a self-evaluated pain assessment form consisting of 15 items. The Worst Pain-item 3 of the BPI-SF scale is used to assess pain on 11-point Likert scale which has range: 0 (no pain) to 10 (pain as bad as you can imagine).
Timepoint [4] 0 0
Baseline up to 5 years

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aragon Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

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]).
Trial website
https://clinicaltrials.gov/show/NCT02257736
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

Summary results
Other publications