Localised prostate cancer Cancer Localised prostate cancer
Conditions
Interventions
Participants are randomised (1:1) into a physical activity intervention arm or the control arm. This is carried out using a computer generated programme by a member of university staff unrelated to th
Sponsors
University of Bristol
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Localised prostate cancer 2. Be due to undergo radical prostatectomy 3. Be due to receive treatment at Southmead Hospital, North Bristol NHS Trust 4. Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience 5. Be aged 18 or over, there is no upper age limit 6. Have sufficient understanding of the English language, including being able to read and speak English at a basic level 7. Be physically able to undergo the brisk walking intervention and CPET static bike assessment
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. The use of a mobility aid other than a walking stick that would prevent them from carrying out the brisk walking intervention 4. Any co-morbidities or other reason for not being able to participate in any aspect of the intervention 5. Participants already achieving physical activity levels over the physical activity intervention level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CPET quantitative measures for fitness pre- and -post exercise intervention are measured using peak oxygen uptake (VO2) and surrogate measures of lung efficiency of ventillatory equivalents for CO2 and O2, as well as the AT Quantitative measures for fitness pre- and -post exercise intervention will include peak oxygen uptake (VO2) and surrogate measures of lung efficiency of ventilatory equivalents for CO2 and O2 measured using Cardiopulmonary exercise testing (CPET) monitoring at baseline and prior to surgery (approx. 4-6 weeks post randomisation / baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effects on markers of proliferation and metabolic pathways, including p AMPK/AMPK, p IGF-I receptor/ IGF-I receptor, FASN, PTEN, IGFBP-2, Ki67 and pACCA/ ACCA are measured using blood and prostate tissue at baseline and prior to/during surgery (approx. 4-6 weeks post randomisation/baseline) 2. Randomisation rates are measured using the proportion of eligible men approached who agree to be randomised baseline 3. Retention rates measured using the number of participants successfully followed-up, as a proportion of those who were randomised just prior to surgery (approx. 4-6 weeks post randomisation/baseline) 4. Change in prostate specific antigen (PSA) level collected via blood sample at baseline and prior to surgery (approx. 4-6 weeks post randomisation/baseline) 5. Change in insulin-like growth factor (IGF-I) level collected via blood sample at baseline and prior to surgery (approx. 4-6 weeks post randomisation / baseline) 6. Change in Quality of life collected via validated questionnaire (The Functional Assessment of Cancer Therapy – Prostate subscale (FACT-P) and Functional Assessment of Chronic Illness Therapy – Fatigue subscale (FACIT-F) questionnaires) at baseline and prior to surgery (approx. 4-6 weeks post randomisation/baseline) | — |
Countries
England, United Kingdom
Contacts
Public ContactLuke Robles
Outcome results
None listed