TITAN, Protocol 56021927PCR3002
Research type
Research Study
Full title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
IRAS ID
185069
Contact name
Frank De Beukelaar
Contact email
Sponsor organisation
Janssen Cilag
Eudract number
2015-000735-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 24 days
Research summary
JNJ-56021927 (also referred to as ARN-509) is an orally available, non-steroidal potent and selective antagonist of the androgen receptor (AR) (anti-androgen). It is a novel type of drug (second generation anti-androgen) that blocks the action of testosterone. By doing so it can slow down or stop the growth of prostate cancer cells. It is currently being developed for the treatment of prostate cancer.
The purpose of this study is to determine if the addition of JNJ-56021927 to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with low volume (metastatic hormone-sensitive prostate cancer (mHSPC ). In this study, patients with mHSPC are those who have received very limited short-term treatment for their prostate cancer.This is a randomized, double-blind, placebo-controlled, multinational, multicenter Phase 3 study in men at least 18 years old to determine if subjects with low-volume mHSPC will benefit from the addition of JNJ-56021927 to ADT. Enrollment of approximately 1,000 subjects is planned for this study and will be conducted mainly across hospital sites globally.
The study will consist of a screening period of up to 28 days, followed by treatment cycles of 28 days where patients will be randomly allocated to receive either JNJ-56021927 plus ADT or matching placebo plus ADT.
The study is expected to end at approximately 6 years (76 months) after the first patient enters treatment. In the event of a positive study result, all subjects will have the opportunity to enroll in an Open label Extension Phase with cycles/visits every 3 months for up to 3 years.
Assessments will include questionnaires, scans, measurement of blood pressure and pulse, ECG, and blood tests for relevant chemical markers.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0274
Date of REC Opinion
23 Oct 2015
REC opinion
Further Information Favourable Opinion