Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007764

Trial Description

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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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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of
JNJ56021927 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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Brief Summary in Scientific Language

This is a randomized (study drug assigned by chance), double-blind (neither the Investigator
nor the participant know the treatment) placebo-controlled and multicenter (when more than 1
hospital or medical school team work on a medical research study) study to determine if
participants with chemotherapy-naive mCRPC will benefit from the addition of JNJ56021927 to
AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment
phase, and Follow-up phase. Participants' safety will be monitored throughout the study.

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Organizational Data

  •   DRKS00007764
  •   2015/02/18
  •   2014/10/02
  •   no
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Secondary IDs

  •   NCT02257736  (ClinicalTrials.gov)
  •   CR105505  (Janssen Research & Development, LLC)
  •   56021927PCR3001 
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Health Condition or Problem studied

  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: JNJ56021927
  •   Drug: Abiraterone acetate
  •   Drug: Prednisone
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Radiographic Progression-free Survival (rPFS).; time frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years; 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.

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Secondary Outcome

- Overall Survival (OS); time frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years; The OS is defined as the time from randomization to date of death from any cause.
- Time to Chronic Opioid Use; time frame: Baseline up to 5 years; Time to chronic opioid use is defined as the time from date of randomization to the first date of opioid use.
- Time to Initiation of Cytotoxic Chemotherapy; time frame: Baseline up to 5 years; Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.
- Time to Pain Progression; time frame: Baseline up to 5 years; 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).

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Belgium
  •   Brazil
  •   Canada
  •   France
  •   Germany
  •   Japan
  •   Korea, Republic of
  •   Mexico
  •   Netherlands
  •   Russian Federation
  •   South Africa
  •   Spain
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

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  •   2014/11/30
  •   960
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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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Addresses

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    • Janssen Research & Development, LLC
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    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical Trial 
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    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   9
  •   2016/04/10


* This entry means the parameter is not applicable or has not been set.