ARANOTE : A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

ThreePhase Three

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Treatment | Urinary systemProstate

Trial Overview Read MoreRead more

This Phase III trial is trying to understand the safety and effectiveness of a hormone therapy drug (darolutamide) in combination with standard hormone therapy (adrogen deprivation therapy) in people with metastatic hormone sensitive prostate cancer..
 

This trial is treating patients with metastatic hormone sensitive prostate cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has 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.

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 Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Commercial Sponsor

Bayer Inc

Summary

This is a randomised study with experimental and placebo comparator arms. Participants in the Experimental Arm will receive darolutamide 600mg (2 tablets of 300mg) orally, twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy. Participants in the Placebo Comparator Arm will receive a placebo (orally) twice daily, and ADT of investigator's choice as standard therapy.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

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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