Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy

Research Summary

Prostate cancer is a major health problem world-wide and is the second most frequently diagnosed male malignancy in the UK It accounts for nearly one fifth of all newly diagnosed male cancers. In the 13K in 1997 over 21000 new cases of pt prostate cancer were diagnosed. In 2001 there were 10001) deaths from prostate cancer; the majority of the patients would have developed metastatic disease some time before death. Because a the paucity of research in prostate cancer the National Cancer Research Institute (NCR1) has identified prostate cancer as high priority for research in the UK.Prostate cancers depend upon the male hormone testosterone for their growth. Lowering testosterone levels (by removing all Or the functioning part of both testes or by anti-hormone injections) slows the growth of prostate cancers This type of treatment is called androgen suppression (AS; or hormone treatment) and is given in the long term as standard treatment to patients whose prostate cancer has spread outside the prostate gland. Although AS is usually successful at stopping the cancer growing for a period of time it is not curative and most tumours will begin to grow again within 18-24 months. Such disease is referred to as hormone refractory prostate cancer (HRPC).A number of newer treatments have recently become available that have shown initial promise against prostate cancer. Such treatments are usually used in HRPC The aim of this trial is to Aim is to test the safety and efficacy of three treatments:zoledronic acid Docetaxel and celecoxib which will be given earlier in the course of the disease (and in combination with AS) before the tumour has become resistant to hormone treatment.-When the disease is advanced; but still hormone-sensitive patients-should be-fitter-and to tolerate the trial treatments-and there is ‘a greater possibility of a larger effect(Very few therapies have improved the survival of men- with advanced prostate cancer in the 50 years since AS was introduced as standard therapy. This is an exciting time in prostate cancer and there is area! oppottunity to improve the outcomes of men starting AS. This trial tests three very different treatments which look most ptoniisiigand in die situation when they may provide the most benefit. Because of the different mechanisms of action of the drugs and based on previous studies two combinations of the treatments will be included for assessment in the trial (see Al0)

Research Overview
PI Name James - ND
Sponsor Medical Research Council
Project Status Open
Proposed End Date 01/06/2019
Study Run through CRF? Yes
Recruitment so far 98