ATLAS: JNJ56021927 (ARN509)
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy
IRAS ID
189007
Contact name
Sadaf Naz Khan
Contact email
Sponsor organisation
Global Clinical Operations, Janssen Research & Development
Eudract number
2015-003007-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 3 months, 7 days
Research summary
This is a randomised, double-blind, multicentre, phase 3 study in male participants at least 18 years old with high-risk, localised or locally advanced prostate cancer. Participants will receive standard care of primary Radiation Therapy (RT), plus Androgen Deprivation Therapy (ADT) in the form of gonadotrophin releasing hormone (GnRH) agonists. Under standard care, patients would also receive an anti-androgen (also known as an antagonist) of the androgen receptor (AR) in the form of bicalutamide. The purpose of these drugs is to lower the production of androgens (male hormone in the form of testosterone) so as to slow down or stop the growth of prostate cancer cells.
The primary objective of this trial is to determine whether JNJ-56021927 (a new anti-androgen that is taken orally), when taken alongside the RT and GnRH agonist, results in an improvement of metastasis-free survival (MSF). That is, a delay in the time taken for the cancer cells to spread to a different area of the body, and a delay in prostate cancer-related death.
Despite the use of ADT in combination with RT, metastatic progression and prostate cancer-related death still occur frequently in patients with High-risk disease. Prostate cancer cells depend on AR signaling for DNA repair after damage from RT and the addition of a GnRH agonist and bicalutamide is proven to improve outcomes. JNJ-56021927 is theorised to be a more complete block to AR signaling than bicalutamide, and so it is theorised that this more complete block will improve clinical outcomes in this patient population.
In this trial, 1500 participants will be randomised into one of two treatment groups - approximately 750 participants will receive RT plus GnRH agonist and bicalutamide (and JNJ-56021927 placebo), and approxiately 750 participants will receive RT plus GnRH agonist and JNJ-56021927 (and bicalutamide placebo).
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0326
Date of REC Opinion
11 Jan 2016
REC opinion
Further Information Favourable Opinion