ENZARAD : Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

Over 18Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

This phase III trial is comparing the use of enalutamide, in combination with standard deprivation therapy and radiotherapy, compared to currently available anti-androgen drugs, for patients with localised prostate cancer.
 

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 are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

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

Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer

Cooperative Group

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

Summary

The study will compare the effectiveness of standard deprivation therapy and radiation therapy combined either with enzalutamide or with currently available antiandrogen drugs for improving the survival in men with localised prostate cancer at high risk of recurrence. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more who has been diagnosed with adenocarcinoma of the prostate, judged to be at high risk for recurrence. You must also be deemed suitable for external beam radiation therapy. Study details Participants in this study will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will be treated with 160mg Enzalutamide daily by mouth for 24 months. Participants in the other group will receive currently available anti-androgen drugs for 6 months. Anti-androgen drugs block testosterone and related androgens from attaching to molecules in the cancer cell called “androgen receptors.” Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Participants will be regularly assessed in order to determine which of these treatments is best at improving the survival of men, as well as the ability of treatments to control prostate cancer, the safety of the treatments, the effects of the treatments on quality of life, and differences in the costs of care

Recruiting Hospitals Read MoreRead more

Box Hill Hospital Medical Oncology
Box Hill
Lesley Poulton
lesley.poulton@easternhealth.org.au
03 9094 9502

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

Peter MacCallum Cancer Centre, Radiation Oncology
East Melbourne
Ms Jenny Trinh
Jenny.Trinh@petermac.org
03 9656 3626

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike Raunow@wh.org.au
03 8395 9167

Not Recruiting Hospitals Read MoreRead more

Not currently recruiting

Austin Hospital
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Epworth Freemasons, Medical Oncology
East Melbourne
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055