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Testing Radical prostatectomy in men with prostate cancer and oligoMetastases to the bone: a randomised controlled feasibility trial

Summary 

TRoMbone will study whether patients can be recruited into a trial that compares current standard care for treating oligo-metastatic prostate cancer (currently androgen deprivation therapy (ADT)) plus radical prostatectomy to standard care alone. TRoMbone is a feasibility study with an embedded Qualitative Recruitment Investigation (QRI), which will optimise recruitment methods for the trial. Should this feasibility trial show that recruitment is possible in this cohort of men, a further funding application will be prepared for a larger study to look at treatment effects. 

Background 

This trial addresses a critical unmet need in managing the health of men with oligo-metastatic prostate cancer. The impact of the study has the potential to dive a paradigm shift in the management of this condition globally. Newer pharmaceuticals have resulted in a few months extra media survival and have been used in castrate-resistant prostate when the cancer in no longer responsive to ADT. However, radical prostatectomy has potential to impact survival before the cancer becomes unresponsive to ADT and my do this to greater extent than novel agents. It may also reduce symptomatic local progression which other therapies cannot offer. With an ageing population there will be a sustained and expanding need for improvements in treatments for metazoic prostate cancer and this research will therefore remain highly relevant and important to the needs of the NHS in the future. 

Aims and objectives

Primary outcome measure:

To test the feasibility to randomise men in the UK to a trial investigating radical prostatectomy (RP) in oligo-metastatic prostate cancer. The feasibility to randomise as determined by 50 patients recruited over 18 months after an initial 3- month set up period; this will be optimised by a QRI.

Secondary outcomes include:

To collect the quality of life in men who have received treatment for oligo-metastatic prostate cancer; EQ-5D-5L questionnaire and safety of treatment arms at follow-up visits. 

To collect oncological outcome in men who have received treatment for oligo-metastatic prostate cancer; time to castrate resistance.

QuinteT Recruitment Investigation (QRI) to understand recruitment challenges for this trial and inform optimal recruitment strategies; findings of the QuinteT Recruitment Investigation (QRI)

Study design

In this study we will evaluate feasibility; i.e. investigate whether patients can be recruited and randomised, prove equipoise, confirm patient ‘flow’ through the study, and assess safety of the intervention. 

Men will be randomised in a 1:1 fashion between the intervention and comparator.

PICO

  • Population: Men aged less than 75 years presenting with newly diagnosed oligo-metastatic, locally resectable prostate cancer; ECOG performance status 0-1. 
  • Intervention: Radical prostatectomy plus Standard Care. 
  • Comparator: Standard Care, currently ADT +/- other systemic therapies. 
  • Outcome: Feasibility: 50 patients recruited over 18 months after an initial 3-month set up period.

 Trial Publications

The study protocol publication can be found here.

 

More information can be found at the below web-links:

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-surgery-for-men-with-prostate-cancer-that-has-spread-to-the-bones-trombone

http://www.hra.nhs.uk/news/research-summaries/trombone/

http://www.bjuinternational.com/bjui-blog/trombone-is-launched/

http://trendsinmenshealth.com/news/trombone-calls-recruits/

 

Mr Prasanna Sooriakumaran, Chief Investigator

Consultant Urological Surgeon, UCL Hospitals NHS Foundation Trust &

Honorary Senior Clinical Researcher, University of Oxford

prasanna.sooriakumaran@nds.ox.ac.uk

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