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GUIDE : A Randomised Non-comparative Phase II Trial of Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

TwoPhase Two

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Treatment | Urinary systemProstate

Trial Overview Read MoreRead more

This Phase II trial is trying to understand how effective chemotherapy (docetaxel) is when delivered intermittently, compared to continuously, in men with metastatic castration-resistant 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 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 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 Randomised Non-comparative Phase II Trial of Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Cooperative Group

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

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

Summary

This is a randomised trial that is assessing whether docetaxel can be effectively delivered intermittently, based on a prostate cancer marker in the blood (mGSTP1), rather than continuously which is the current standard of care. In the Experimental Arm, participants will receive 3 cycles of docetaxel chemotherapy (75mg/m^2 every 21 days) in combination with undetectable mGSTP1 level and then will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days and docetaxel treatment will be recommenced if mGSTP1 becomes detectable again. In the Active Comparator Arm, participants will receive the standard of care docetaxel treatment of continuous docetaxel treatment.

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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