Proteus : A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

This phase III trial is evaluating an oral prostate cancer treatment (Apalutamide) in patients with high risk, localised or locally advanced prostate cancer who are eligible for surgery.
 

This trial is treating patients with prostate cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Commercial Sponsor

Janssen-Cilag Pty Ltd

Summary

Eligible patients will be randomised to receive androgen deprivation therapy plus oral Apalutamide or a placebo daily in each (28 day) cycle. Participants will receive six cycles of treatment, followed by radical prostatectomy, followed by an additional six cycles of treatment.

Recruiting Hospitals Read MoreRead more

Box Hill Hospital Medical Oncology
Box Hill
Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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