ARASENS : A Randomized, Double-blind, Placebo Controlled Phase III Study of ODM-201 Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

Male<br/>OnlyGender Male
Only

Closed (no longer recruiting)Status Closed (no longer 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 the addition of an oral drug (ODM-201) to standard androgen deprivation therapy and docetaxel (a steroid) in patients with hormone sensitive prostate cancer that has spread to other parts of the body.
 

This trial is treating patients with 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.
  • 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.
  • 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

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Scientific Title

A Randomized, Double-blind, Placebo Controlled Phase III Study of ODM-201 Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

Commercial Sponsor

Bayer Inc

Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization. The subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel. Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the Investigator or his/her designated associate(s), death, non-compliance, or if Sponsor terminates the study.

Not Recruiting Hospitals Read MoreRead more

Closed

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9288 3167

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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