ANZUP trials in follow up
Trials in follow up Once a clinical trial is finished, researchers scrutinise all the information collected during the course of the study. Reviewing all the data allows researchers to decide whether the results mean the new drug or device should continue to the next phase of clinical trial, or, when applicable, seek approval for broader use by the appropriate authorities. Once a new drug or device has been proven to be effective and safe, it may become part of standard treatment for the condition or disease. Review and analysis of the information can take an extended period of time. So there may be a delay before the results of a clinical trial are known. This is definitely the case with larger trials that can involve thousands of people from many hospitals both in Australia and overseas. In large multi-centre trials, the examination of the data and outcomes may take place over several years. If you have taken part in a trial and specified you wish to know the overall results of the trial, the researchers should make them available to you directly. Usually results of all completed studies will also be made available in papers or reports published in scientific journals. ANZUP now has nine trials in follow-up across four of the below the belt cancer types – bladder, testicular, prostate and kidney cancer.
ANZUP Trials 1. BL12 – Bladder Cancer This study was designed to look at whether NabPaclitaxel improves survival and is less toxic, with improved quality of life, compared with Paclitaxel in people with advanced or metastatic urothelial cancer, in the setting where the cancer has grown or come back during or within 12 months of completion of platinum based chemotherapy. Urothelial transitional cell cancer (uTCC) is a type of cancer that typically starts in the cells that line the inside of the urinary system. People with “advanced or metastatic urothelial cancer” have cancer which has spread beyond the region of the urinary system, typically to lymph nodes, the wall of the abdomen or pelvis, bones or other organs. Chemotherapy is commonly used in this situation. Chemotherapy drugs of a type called taxanes have commonly been used as a second line treatment. This family of chemotherapy drugs include Nab-Paclitaxel and Paclitaxel. Recruitment to this study ceased on the 7th April 2017 and sites are being closed out. As part of this process,
56 A LITTLE BELOW THE BELT
sites are required to submit documents and begin the process of archiving all trial records for 15 years from the end of the trial. And once it becomes available, the final trial publication will be submitted to the Human Research Ethics Committee.
2. ENZAMET – Prostate Cancer 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 was undertaken to 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 was 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. This landmark Australian led clinical trial, ENZAMET, has now shown that hormone therapy with a drug called enzalutamide can improve the survival of some men with advanced, hormone-sensitive prostate cancer. Findings from the ENZAMET trial, led by ANZUP, have shown that men with this sort of cancer who receive enzalutamide with standard treatment have a 33% improvement in survival compared to men receiving standard treatment alone and a 60% improvement in the time it takes to detect the cancer growing again. These results were much better than it was thought they might be when the trial began.
3. ENZARAD – Prostate Cancer ENZARAD is a randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer. 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 has been led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre.
