Men who choose radical surgery for prostate cancer (radical prostatectomy) can experience side effects, including urine leakage and problems with erections. This project aims to develop a new questionnaire for measuring urinary and sexual function following radical prostatectomy in men in the UK.
|Prostate cancer is the commonest cancer and the second most frequent cause of cancer death in Western men1. Men presenting with metastatic disease have a median survival of only 42.1 months2 and current standard-of-care consists of initial androgen deprivation therapy (ADT) followed by chemotherapy and novel agents once the cancer no longer responds to ADT. The burden on the health care setting of treating men with metastatic prostate cancer is vast and a recent study estimated costs of USD20,000 per man3. There is emerging data that radical therapy directed at the prostate impacts survival, especially in those with limited metastatic burden, defined as 1-3 skeletal lesions without any visceral metastases (oligo-metastases). Further, many men suffer symptomatic disease progression and eventually require palliative surgical intervention, which is less frequent in those treated with initial radical prostatectomy compared to systemic therapy alone4,5. Hence, our ultimate aim is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer. Currently we have low-level evidence from biological and epidemiological studies and we need to provide a high level of evidence with a clinical trial to properly interrogate the hypothesis that radical prostatectomy improves survival in men with oligo-metastatic prostate cancer. However, randomisation to surgical trials is fraught with difficulty and a number of high-profile prostate cancer trials have failed to recruit. Hence, before commencing a full trial, it is imperative to assess the feasibility of the study. One major success in recruitment terms was the Prostate Testing for Cancer and Treatment (ProtecT) study (http://www.nets.nihr.ac.uk/projects/hta/962099) which employed a qualitative recruitment investigation (QRI) run by the University of Bristol School of Social and Community Medicine; we will therefore similarly integrate a QRI in this feasibility study.|
|An Open label phase I / randomized, double blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 in combination with Docetaxel and Prednisolone chemotherapy (DP)
This study is for patients with metastatic castration resistant prostate cancer who are suitable to receive palliative docetaxel chemotherapy.
The overall aim of this study is to determine if the addition of the AKT inhibitor AZD5363 to docetaxel and prednisolone prolongs progression free survival to a degree worthy of further investigation
|This is a randomised, double blind, placebo controlled, multicenter, parallel-group Phase III study to evaluate the efficacy and safety of DCVAC/PCa versus placebo in men with metastatic castration resistant prostate cancer (mCRPC) eligible for 1st line.
All subjects will receive up to 15 injections of DCVAC/PCa or placebo or until refusal, intolerance, introduction of 2nd line treatment or death occurs. All subjects will also receive Standard of Care chemotherapy until refusal, intolerance, completion, disease progression, or death. DCVAC/PCa treatment will continue as a
Maintenance Boosting Phase after Standard of Care chemotherapy completion, refusal, intolerance or discontinuation for other reasons.
Subjects may be treated with subsequent non-immunological therapies at the Investigator’s discretion until refusal, death or study closure. After screening (up to 28 days) and within 14 days of randomization, all subjects will have leukapheresis procedure. For those randomized to receive DCVAC/PCa, PBMCs obtained by leukapheresis will be processed by ex-vivo manipulation (up to 4 weeks). All subjects randomized to receive placebo injections will have a placebo prepared.
This is a multi-centre, randomised controlled trial for patients with locally advanced or metastatic prostate cancer who are about to commence androgen suppression (AS) therapy. The trial aims to investigate the efficacy and safety of 3 different drugs in combination with AS. The drugs are zoledronic acid, docletaxel and celecoxib.
All patients will receive AS, men in the research arms will receive one or two of the research drugs as well.