Prostate Cancer Trials

DASL-HiCaP Trial 

The purpose of this study is to see if a new tablet drug, darolutamide, combined with the current best treatments, can improve outcomes for men with high risk prostate cancer that has not spread beyond the prostate area. Previous studies have shown promising results for darolutamide preventing disease progression and improving survival for men with advanced prostate cancer. This is a randomised controlled trial, which means that, in addition to best standard treatments, half the participants on the study will receive darolutamide, and the other half will receive placebo. The trial is being led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. We plan to enrol 1,100 men from Australia, New Zealand, Canada, the US, Ireland, and the UK. 

The trial is open and recruiting.

UpFrontPSMA Trial 

Most prostate cancer cells have a molecule on their surface called prostate cancer specific membrane antigen (PSMA). PSMA can be targeted with Lutetium-177 PSMA (Lu-PSMA), a radioactive drug that kills prostate cancer cells anywhere in the body. This investigational drug is not approved for use in Australia by the Federal Government’s Therapeutic Goods Administration (TGA).  It is a new form of treatment that is effective in some patients with metastatic prostate cancer.  It is a radioactive substance that, after injection into a vein, attaches to prostate specific membrane antigen (PSMA).  The treatment enables delivery of highly targeted radiation to cancer cells. The emitted radiation only travels about 1mm, which means it mainly causes the killing of cancer cells, while avoiding healthy cells, and seems to be well tolerated with few side effects.  This is called radionuclide therapy or theranostic therapy. 

The purpose of this randomised controlled clinical trial is to compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own. Previous clinical trials have shown promising activity of Lu-PSMA in treatment of patients with metastatic prostate cancer. 

Docetaxel is a chemotherapy drug that is approved by the TGA to treat prostate cancer and has been used for many years in the treatment of metastatic prostate cancer.

Since Lu-PSMA radiotherapy and docetaxel chemotherapy are both effective in treating metastatic prostate cancer, it is possible that using Lu-PSMA in addition to standard docetaxel chemotherapy at the beginning of the treatment course may improve patient outcomes when compared to treatment with docetaxel alone.  A recent phase 2 clinical trial, showed the effectiveness of Lu-PSMA when used as a last treatment option and helped control disease progression.  This study brings the use of Lu-PSMA forward as a first option to patients, with the hope of disease eradication and potential cure.

The trial is open and recruiting.

NINJA Trial

The NINJA clinical trial aims to compare two emerging schedules of radiotherapy in the treatment of intermediate or high risk prostate cancer. Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In schedule 1 (called Stereotactic Body Radiotherapy) participants will receive 5 radiotherapy treatments over 2 weeks, and in schedule 2, (called Virtual High Dose Rate Boost), participants will receive Stereotactic Body Radiotherapy delivered in 2 treatments over 1 week followed by 12 treatments of conventional external beam radiotherapy over 2 and a half weeks. It is hoped this research will potentially improve the accuracy and quality of radiotherapy treatment in prostate cancer.

Interested in this trial? Print off the NINJA trial details from the Australia New Zealand Clinical Trials Registry and take it to your GP.


Trials in follow up:

ENZAMET Trial

Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with enzalutamide can improve survival and quality of life in men starting hormone treatment for newly diagnosed prostate cancer that has spread beyond the prostate. The trial is being led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. It involved 1,125 men from Australia, New Zealand, Canada, the US, Ireland, and the UK.

In June 2019 ANZUP reported that the ENZAMET clinical trial met its primary endpoint of improved survival at the planned first interim analysis. Men with metastatic hormone sensitive prostate cancer (mHSPC) received enzalutamide or non-steroidal anti-androgen therapy (NSAA: bicalutamide, nilutamide, or flutamide) in addition to standard of care therapy (androgen deprivation therapy, ADT), with or without docetaxel chemotherapy. The ENZAMET trial showed a 33% improvement in overall survival and a 60% improvement in progression-free survival, for men who received enzalutamide. This translated into 80% chance of survival at 3 years with enzalutamide versus 72% with NSAA. 

This trial is now in follow up and closed to recruitment.

To learn more about ENZAMET, including detailed results from the trial, please click here.

TheraP Trial

Lutetium-177 PSMA radionuclide therapy (Lu-PSMA) is a new treatment for advanced prostate cancer. Lu-PSMA is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues. Previous small studies of Lu-PSMA showed promising activity in patients with advanced prostate cancer.

This randomised study will compare Lu-PSMA with a type of chemotherapy called cabazitaxel, which is the standard treatment for advanced prostate cancer when other treatments have stopped working. Half the participants will receive Lu-PSMA and half will receive cabazitaxel. This study will provide further information about the risks and benefits of Lu-PSMA compared with cabazitaxel in men with prostate cancer. We plan to enrol 200 participants in the study in Australia. 

This trial is now in follow up and closed to recruitment. 

For more information, including FAQs click here. 

Pain-Free TRUS B Trial

A prostate biopsy involves taking small pieces of the prostate through a needle so that it can be looked at with a microscope. A TransRectal UltraSound (TRUS) guided biopsy is the usual way of performing a biopsy and involves inserting a thin needle through the wall of the rectum into the prostate using the guidance of an ultrasound probe. An injection of a local anaesthetic (lignocaine) around the prostate is the standard way of reducing the discomfort of a prostate biopsy.  
 
Methoxyflurane (Penthrox®) is a drug given with a simple inhaler and is widely used by first aid services to reduce pain. This randomised trial will determine if the discomfort of prostate biopsies can be reduced by giving men inhaled methoxyflurane in addition to their standard injections of local anaesthetic. This study will include 420 men and is being conducted by ANZUP Cancer Trials Group in collaboration with the NHMRC Clinical Trials Centre, University of Sydney.

We acknowledge MDI for the provision of Penthrox®. 

This trial is now in follow up and closed to recruitment. 

proPSMA Trial

Prostate cancer is the most commonly diagnosed cancer in Australian men. If detected early, when disease has not spread there is a high chance of cure. Relapse, however, is not uncommon despite careful selection of patients prior to surgery or radiotherapy. This, in part, reflects a failure to detect disease spread at baseline due to limited accuracy of current scanning techniques. More accurate scanning may improve outcomes by redirecting patients with disease spread from futile local treatments to more appropriate management.

This clinical trial will investigate a new type of scan which provides whole body images of prostate cancer spread. Early experience suggests that this new technology, called PSMA PET/CT (prostate specific membrane antigen positron emission tomography/computed tomography), is superior to current scanning techniques. PSMA PET/CT has capacity for wide availability at relatively low cost. Performing a single better test rather than several less accurate scans will also be cheaper, improve patient experience and expose patients to lower amounts of radiation.

This is a randomised study at multiple centres around Australia comparing PSMA-PET/CT to conventional imaging. If the initial work-up does not demonstrate tumour spread, patients will cross-over to the other imaging arm. We hope to prove that PSMA-PET/CT has superior diagnostic performance, should be used as a first-line test for staging prior to surgery or radiotherapy and will result in significant changes to patient management. Results of this trial will be used to support funding of this new technology in Australia and internationally. 

This trial is now in follow up and closed to recruitment. 


ENZARAD Trial

Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with enzalutamide can improve survival and quality of life in men starting radiation and hormone therapy for prostate cancer that does not seem to have spread beyond the prostate. The trial is being led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. It is planned to include 800 men from Australia, New Zealand, Canada, the US, Ireland, and the UK.  

This trial is now in follow up and closed to recruitment. 


Living Well with Prostate Cancer

Prostate cancer is the most common male cancer in developed countries and there are approximately 22,000 Australian men alive today with advanced prostate cancer. Research into the impact of advanced prostate cancer shows that men report higher levels of psychological distress, poorer quality of life, and have an increased risk of suicide compared to men with localised disease. Additionally, many men report they do not receive enough support after their diagnosis. This project is trialling a professionally led and telephone delivered mindfulness-based cognitive therapy (MBCT) group intervention for men with advanced prostate cancer. MBCT is designed to assist men with stress management and improve their psychological wellbeing and in this trial its effectiveness will be compared to an educational program consisting of the best available resources for men with advanced prostate cancer.

This trial is now in follow up and closed to recruitment.




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