Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

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

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

ThreePhase Three

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Multiple treatment types,Radiotherapy,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 and radiation 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

Alfred Hospital, William Buckland Radiotherapy Centre
Prahran
Ms Robin Smith
r.smith@alfred.org.au
03 9076 2360

Box Hill Hospital Medical Oncology
Box Hill
Ms Karen Lim
karen.lim@monash.edu
03 9094 9564

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
Parkville Research
RadOnc.Research@petermac.org

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
CancerClinicalTrials@wh.org.au
0434 915 739

Not Recruiting Hospitals Read MoreRead more

Closed

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

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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