TRoMbone
Research type
Research Study
Full title
Testing Radical prostatectomy in men with prostate cancer and oligoMetastases to the bone: a randomised controlled feasibility trial
IRAS ID
202786
Contact name
Prasanna Sooriakumaran
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN15704862
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Prostate cancer is the commonest cancer and the second most frequent cause of cancer death in Western men. Men presenting with metastatic disease have a median survival of only 42.1 months 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.
TRoMbone aims to find out whether it would be possible to conduct a large study randomly allocating men with oligo-metastatic prostate cancer (3 or fewer bone metastases) to hormone treatment alone or hormones plus radical prostatectomy (surgery to remove the prostate). In this study, we need to compare people who have radical prostatectomy plus androgen deprivation therapy to those having ADT alone as their initial treatment for oligo-metastatic prostate cancer. There is also a 'qualitative research investigation' (QRI) embedded within this study. This means that patients will also be asked to give their consent for their information visits to be tape recorded for analysis. This is to inform the design of a possible larger study. There will be 3 study sites and we aim to recruit 50 men.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0376
Date of REC Opinion
14 Sep 2016
REC opinion
Further Information Favourable Opinion