Prostate cancer Cancer Localised and locally advanced malignant neoplasm of prostate
Conditions
Interventions
Participants are randomised into two groups, the intervention or the control. The intervention will be either physical activity or to take metformin. Each participant will be randomised within the tre
Sponsors
University of Bristol
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Localised or locally advanced prostate cancer 2. Due to undergo radiotherapy or radical prostatectomy, or due to begin the active surveillance pathway 3. Due to receive treatment at Southmead Hospital, North Bristol NHS Trust or Bristol Haematology & Oncology Centre (University Hospitals Bristol NHS Trust) 4. Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience 5. Aged 18 or over 6. Have sufficient understanding of the English language, including being able to read and speak English at a basic level
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent or unavailability for follow-up 2. Being identified as unsuitable to participate following guidance of their clinician 3. Currently taking metformin or insulin 4. Co-morbidities which could prevent participation in the metformin arm of the intervention, including: 4.1. Diabetes 4.2. Hypersensitivity to metformin hydrochloride or to any of the excipients 4.3. Diabetic ketoacidosis, diabetic pre-coma, renal failure or renal dysfunction (eGFR <30mL/minute/1.732) 4.4. Acute conditions with the potential to alter renal function such as: 4.4.1. Dehydration 4.4.2. Severe infection 4.4.3. Shock 4.4.4. Intravascular administration of iodinated contrast agents 4.4.5. Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure or recent myocardial infarction 4.5. Hepatic insufficiency 4.6. Acute alcohol intoxication 4.7. Alcoholism 4.8. Stoma 5. Use of a mobility aid other than a walking stick, which would prevent them from carrying out the brisk walking intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of eligible men who agree to be randomized 2. Adherence to intervention, calculated separately for physical activity and metformin, assessed at 3 and 6 months after start of intervention. 2.1. For physical activity, adherence will be assessed by step count, recorded by pedometer and reported by the participant. 2.2. Metformin will be assessed by a count of the pills returned by the participant to the research clinics. In addition, blood samples will be taken which may be examined for metformin. 2.3. Both of these will be assessed for participants in the physical activity and metformin group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intervention tolerability, assessed using qualitatively collected data and reporting of adverse events from qualitative interviews for selected participants after the end of the 6 month intervention period 2. Trial retention, assessed by number of participants successfully followed-up at the end of the 6 month trial, as a proportion of those who we recruited to the trial and randomised into a study arm at the start of the trial) 3. Feasibility of measuring prostate specific antigen (PSA) level, assessed using a blood sample at the baseline and 6 month follow up 4. Feasibility of measuring insulin-like growth factor I (IGF-I), assessed using a blood sample at the baseline and 6 month follow up 5. Feasibility of demonstrating methylation and gene expression profiles in prostate tissue and blood, assessed using blood and tissue samples (prostate tissue removed during surgery and tissue removed during biopsy as part of standard care) at the baseline and 6 months 6. Feasibility of assessing physical activity levels, self-reported using the Godin Exercise Leisure-time Questionnaire at the baseline, 3, 6 and 12 months 7. Urinary symptoms, assessed using the International Continence Society male - Short Form (ICSmale-SF) at the baseline and 3, 6 and 12 month follow up, along with 7 weeks following main consent for the surgical patients 8. Psychological factors, assessed at the baseline and 3, 6 and 12 month following using: 8.1. Profile of Mood States – Short Form (POMS-SF) 8.2. Benefit Finding Scale 9. Patient function and bother after prostate cancer treatment, assessed using he Expanded Prostate Cancer Index Composite (EPIC-26) at the baseline and 3, 6 and 12 months follow up 10. Health beliefs, assessed at the baseline and 3, 6 and 12 month follow up using: 10.1. Items from the Theory of Planned Behaviour (Ajzen, 1991) - there is no standard TPB questionnaire but Ajzen provided advice on questionnaire construction and gave examples and the questionnaire was designed | — |
Countries
England, United Kingdom
Contacts
Public ContactLuke Robles
Outcome results
None listed