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Closed (no longer recruiting)Last updated: 17 October 2023

Proteus: 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 surgeryA 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

Clinical summary

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.

Conditions

This trial is treating patients with prostate cancer.

Cancer

Urinary System Cancers Urinary System

Age

People18+

Phase

III

Trial Acronym

Proteus

More information

Trial Identifiers

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Commercial Sponsor

Janssen-Cilag Pty Ltd

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

Eligibility

Inclusion

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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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