56021927PCR3001 - Prostate Cancer Study

• Research type

  Research Study

• Full 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)

• IRAS ID

  170731

• Contact name

  Gerhardt Attard

• Contact email

  gerhardt.attard@icr.ac.uk

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2014-001718-25

• Clinicaltrials.gov Identifier

  NCT02257736

• Duration of Study in the UK

  6 years, 7 months, 1 days

• Research summary

  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]).

  This is a randomised (study drug assigned by chance), double blind (neither the Investigator nor the participant know the treatment) placebo controlled and multicentre (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 Followup phase.
  Participants' safety will be monitored throughout the study.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  15/LO/0165

• Date of REC Opinion

  2 Apr 2015

• REC opinion

  Further Information Favourable Opinion