Prostate cancer-Exercise and Metformin Trial (Pre-EMpT): study protocol for a feasibility factorial randomized controlled trial in men with localised or locally advanced prostate cancer

Lucy McGeagh; Luke A Robles; Raj Persad; Edward Rowe; Amit Bahl; Jonathan Aning; Anthony Koupparis; Paul Abrams; Claire Perks; Jeffrey Holly; Lyndsey Johnson; Constance Shiridzinomwa; Amarnath Challapalli; Ellie Shingler; Hilary Taylor; Jon Oxley; Meda Sandu; Richard M Martin; J Athene Lane

doi:10.1186/s40814-022-01136-7

Prostate cancer-Exercise and Metformin Trial (Pre-EMpT): study protocol for a feasibility factorial randomized controlled trial in men with localised or locally advanced prostate cancer

Pilot Feasibility Stud. 2022 Aug 12;8(1):179. doi: 10.1186/s40814-022-01136-7.

Authors

Lucy McGeagh^#^{1

2}, Luke A Robles^#¹, Raj Persad³, Edward Rowe³, Amit Bahl⁴, Jonathan Aning³, Anthony Koupparis³, Paul Abrams³, Claire Perks⁵, Jeffrey Holly⁵, Lyndsey Johnson⁶, Constance Shiridzinomwa⁶, Amarnath Challapalli⁴, Ellie Shingler¹, Hilary Taylor^{1

7}, Jon Oxley⁸, Meda Sandu¹, Richard M Martin^#^{1

7}, J Athene Lane^#^{9

10}

Affiliations

¹ NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
² Supportive Cancer Care Research Group, Faculty of Health and Life Sciences, Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.
³ Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.
⁴ Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
⁵ Insulin-like Growth Factors and Metabolic Endocrinology Group, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
⁶ Clinical Research Centre, North Bristol NHS Trust, Bristol, UK.
⁷ Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.
⁸ Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.
⁹ NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. Athene.Lane@bristol.ac.uk.
¹⁰ Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK. Athene.Lane@bristol.ac.uk.

^# Contributed equally.

Abstract

Background: Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life.

Methods: Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up.

Discussion: Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions.

Trial registration: Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667 . Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018.

Keywords: Active surveillance; Feasibility randomised controlled trial; Localised; Locally advanced; Metformin; Physical activity; Prostate cancer; Prostatectomy; Radiotherapy.

Grants and funding

BRC-1215-20011/NIHR Biomedical Research Centres Competition 2016