MAGNITUDE

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer.

• IRAS ID

  257331

• Contact name

  Omi Parikh

• Contact email

  omi.parikh@lthtr.nhs.uk

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2017-003364-12

• Duration of Study in the UK

  5 years, 11 months, 12 days

• Research summary

  This is a study of a medication called niraparib, in combination with abiraterone acetate plus prednisone (AA-P - a common treatment), for the treatment of patients with metastatic prostate cancer. Metastatic cancer occurs when cancer spreads to another area of the body from where it started. The objective of this study is to evaluate the effectiveness of niraparib plus AA-P compared to AA-P with a placebo.

  Participants will be split into two cohorts: those who are identified as having DNA-repair gene defects (DRD), and those who have no DRD. Within those cohorts, participants will be split evenly at random (randomised) to receive either the study medication (niraparib) or the placebo.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  19/NW/0103

• Date of REC Opinion

  17 Apr 2019

• REC opinion

  Further Information Favourable Opinion