Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
A randomised phase III trial of Docetaxel plus Prednisolone vs. Docetaxel with Prednisolone plus either Zoledronic acid, Strontium-89 or both agents combined (TRAPEZE) |
Project ref: |
06/303/205 |
Cost: |
£749,147 |
Chief Investigator : |
Professor Nicholas James, Professor of Clinical Oncology, Department of Clinical Oncology, University of Birmingham |
Start Date: |
April 2007 |
Estimated date of publication in HTA journal series: |
Mid 2014. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Advanced prostate cancer is initially treated by hormone therapy to either block or remove the stimulatory effects of male hormones on the cancer. Eventually prostate cancer will become resistant to hormone manipulation and the cancer will start to regrow and spread despite these treatments - termed hormone refractory prostate cancer (HRPC). It is estimated that around 10000 men develop this condition each year in the UK. The cancer frequently spreads to the bones (around 90% of cases) causing a variety of serious problems including pain and fractures. A range of treatments are used for HRPC including chemotherapy, radio-isotope therapy and bone hardening agents called bisphosphonates. The trial is looking at 4 possible ways of combining these agents in order to define which best extends the duration of survival time that patients are free of disease progression including pain and skeletal related events. The study doctors and nurses will collect data on treatment side effects and complications. The trial will also examine the health care costs of the different strategies as well as seeking to establish whether any of the combinations will prolong overall survival. All of the trial treatments are already licensed for the treatment of HRPC but are not uniformly available for reasons of cost. We do not thus think the trial poses any particular ethical problems. It is possible that using an expensive treatment early may actually save healthcare costs later (e.g. by preventing a fracture) and the trial thus has important implications for provision of services for men with advanced prostate cancer. All treatments will be carried out within hospital oncology outpatient departments where these patients would ordinarily receive their treatment off trial. The team leading the research are based at the Cancer Research Clinical Trials Unit at the University of Birmingham, which is a designated trials centre for the National Cancer Research Network. The team members have extensive experience in clinical trials, health economics and trial statistics. It is estimated that 40 centres will participate in this study. The costs requested to run this study are to employee a team of qualified personnel and provide equipment to ensure the safe and efficient management and analysis of data for this large multi centre study. |
Project Abstract: |
Advanced prostate cancer is initially treated by hormone therapy to either block or remove the stimulatory effects of male hormones on the cancer. Eventually prostate cancer will become resistant to hormone manipulation and the cancer will start to regrow and spread despite treatments - termed hormone refractory prostate cancer (HRPC). It is estimated that around 10000 men develop this condition each year in the UK. The cancer frequently spreads to the bones (around 90% of cases) causing a variety of serious problems which include pain and fractures. A range of treatments are used for HRPC including chemotherapy, Radio-isotope therapy and bone hardening agents called Bisphosphonates. The trial is looking at 4 possible ways of combining these agents to define the combination which best preserves quality of life, Quality of life will be assessed by standard questionnaires. The study doctors and nurses will collect data on treatment side effects and complications. The trial will also examine the health care costs of the different strategies as well as seeking to establish whether any of the combinations will prolong overall survival. All of the trial treatments are already licensed for the treatment of HRPC but not uniformly available for reasons of cost. We do not thus think the trial poses any particular ethical problems. It is possible that using an expensive treatment early may actually save healthcare costs later. (E.g. by preventing a fracture) and the trial thus has important implications for provision of services for men with advanced prostate cancer. All treatments will be carried out via hospital oncology departments where these patients would receive there treatment off trial. The team leading the research are based at the University of Birmingham Cancer Trials Unit, which is the designated trials centre for the National Cancer Research Network. The team members have extensive experience in clinical trials, health economics and trial statistics. |
NRR* number, if applicable: |
N0484196297 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 12808747 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN12808747 |
Project Protocol: |
Project protocol (pdf format, 544 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1605 |
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