Title: Improving outcomes for men with prostate cancer
Funder: Medical Research Council

Abstract: We seek to improve outcomes, reduce side-effects and reduce over-diagnosis and over-treatment in the most common male cancer: prostate cancer.|Prostate cancer is a big problem. It is increasingly common (30,000 new UK cases in 2005), particularly with diagnosis of earlier stages of disease. Most men may develop prostate cancer if they live sufficiently long. The prognosis for men with clinically relevant, high-risk prostate cancer has not greatly improved for many years and requires studying. Many prostate tumours are slow growing and remain clinically unimportant. Men with early stage disease are likely to die with than of prostate cancer. Here, we must balance providing effective treatment with avoiding unwanted treatment side-effects. |Our programme aims to improve outcomes, especially survival, for men with prostate cancer using novel approaches or novel methods. We wish to reduce over-diagnosis of clinically irrelevant tumours and reduce over-treatment. We wish to design and implement methods for speeding up trials and prostate cancer is a good testing ground for this.|In recent years, we have shown that:|a first-generation bisphosphonate drug may make men with metastases live longer (PR05, ISRCTN38477744) but not men with earlier disease (PR04, ISRCTN61384873)|men live longer if given radiotherapy with hormone therapy, the mainstay of treatment for more advanced disease (PR07, NCIC PR.3, ISRCTN24991896)|in men with less advanced disease, higher doses of radiotherapy can give better prostate cancer outcomes without increasing unwanted effects when using modern conformal radiotherapy methods (RT01, ISRCTN47772397). in men with less advanced disease, higher doses of radiotherapy can give better prostate cancer outcomes without increasing unwanted effects when using modern conformal radiotherapy methods (RT01, ISRCTN47772397).|We have 3 studies open to recruitment and one to open. STAMPEDE (MRC PR08, ISRCTN78818544) is a flagship trial for men starting long-term hormone therapy. It uses new multi-arm multi-stage (MAMS) methods to supplement standard hormone therapy with 5 combinations of 3 drugs: doctaxel (a taxane chemotherapy), zoledronic acid (a potent, third-generation bisphosphonate) and celecoxib (a selective cox-2 inhibitor). More than 1500 patients from the UK and Switzerland have already joined this 6-arm trial.|PATCH (PR09, ISRCTN70406718) looks at whether oestrogen-based therapy can be administered more safely using patches rather than tablets; this method bypasses the liver pathways and cardiovascular problems should be reduced and efficacy improved. This is a novel idea. PATCH reached its target of 250 patients and will continue further.|RADICALS (PR10, NCIC PR-13, ISRCTN40814031) assesses two important questions for men who have chosen radical prostatectomy for localised prostate cancer: (i) the use and timing of post-operative radiotherapy, balancing potential efficacy and potential over-treatment; and (ii) the use of hormone therapy with any post-operative radiotherapy. RADICALS will recruit around 4,000 men from the UK, Canada, Denmark and beyond.|The new study evaluates multi-functional MRI in the diagnosis and characterisation of prostate cancer with a view to reducing over-diagnosis of clinically irrelevant tumours and over-treatment.


Research activity codes: 6.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES;6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS