DASL-HiCaP : Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

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 trying to understand the effectiveness of a hormone therapy in men requiring radiation therapy for localised prostate cancer that has a high risk of coming back after treatment.
 

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

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

Cooperative Group

Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Other Non-Commercial Sponsor

University of Sydney

Summary

Eligible patients will be randomised to receive 2x300mg tablets of Darolutamide or a placebo twice daily for 96 weeks. All patients will be treated with Luteinizing Hormone-Releasing Hormone Analog (LHRHA) for 96 weeks from randomisation and commence radiation therapy within 8-24 weeks of randomisation.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Peter MacCallum Cancer Centre Bendigo
Bendigo
Ms Catherine Anderson
catherine.anderson@petermac.org
03 5454 9234

Peter MacCallum Cancer Centre
Moorabbin
Moorabbin Research
moorabbin.research@petermac.org
03 9928 8994

Peter MacCallum Cancer Centre, Radiation Oncology
Parkville
Smitha Sithara
Smitha.sithara@petermac.org
03 8559 8771

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.

Next