None listed
Conditions
Brief summary
The ACTIDIET-PRO study aims to evaluate the feasibility of an exercise and diet intervention in Australian men with metastatic hormone-resistant prostate cancer who are treated at a single centre. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have been diagnosed with adenocarcinoma of the prostate, and are receiving ongoing treatment with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) such as Abiraterone/Prednisone, Apalutamide, Darolutamide or Enzalutamide. To be deemed eligible for this trial, you must have a rising PSA with no evidence of clinical or radiographic progression on imaging evaluation, and your doctor must consider that continuation of your current systemic treatment is feasible. Study details: All participants who meet the eligibility criteria in this study will undertake a 12-week lifestyle intervention of intensified physical activity and a controlled dietary regimen. Exercise prescription will be tailored to each participant’s fitness and comorbidities, and will consist of two supervised sessions per week and one pre-instructed home-session, including cardio and resistance training. The dietary regimen will consist of a balanced diet consisting of low total fat, low saturated fat, high omega-3 fatty acids, optimised protein content and low simple carbohydrates. During and after the completion of the intervention participants will be assessed for prostate-specific antigen (PSA), and questionnaires assessing quality of life and fatigue. Changes in lipid and immune signatures will be assessed through serial blood profiling. It is hoped that this research project will help in understanding whether benefits from of diet and exercise prescription in men with early stage of prostate cancer can be replicated in men who suffer from a more advanced stage of disease.
Interventions
Enrolled participants will undertake a 12-week lifestyle intervention of intensified physical activity and a controlled dietary regimen.
Exercise prescription is supervised by an exercise physiologist, and will be tailored to each participant’s fitness and comorbidities. The exercise intervention consist of two face to face small group (up to 6 participants) or individual supervised sessions per week lasting up to one hour, and one pre-instructed home-session (duration personalised, usually 30-
Enrolled participants will undertake a 12-week lifestyle intervention of intensified physical activity and a controlled dietary regimen. Exercise prescription is supervised by an exercise physiologist, and will be tailored to each participant’s fitness and comorbidities. The exercise intervention consist of two face to face small group (up to 6 participants) or individual supervised sessions per week lasting up to one hour, and one pre-instructed home-session (duration personalised, usually 30-60 minutes) including cardio and resistance training. The level of intensity is assessed via Borg RPE (target 13-15). Examples of assessments performed during the intervention may include a 6-minute walk test and stair climbing test. Examples of training prescribed during the intervention include: aerobic exercise such as step count prescription and cycling, and resistance training exercises such as dumbbell press, theraband row, and squats. The specific prescription will vary from participant to participant, according to the expertise of the treating exercise physiologist. The dietary regimen will consist of a balanced diet consisting of low total fat, low saturated fat, high omega-3 fatty acids, optimised protein content and low simple carbohydrates. Participants are encouraged to aim to adhere to the diet for as many meals as possible during the 12 week intervention, and will be provided access to over 70 pages of handouts and recipes enabling them to prepare their own meals and identify healthy meals on a menu. They will also have 2 follow up diet consultations throughout the intervention to address any concerns and queries. Adherence is assessed via determining the fraction of scheduled physical activity appointments and self-trainings attended and carried out by patients, the fraction of exercises completed during face-to-face training sessions and the fraction of days of adherence to the prescribed dietary regimen according to structured 24 hour dietary recall.
Sponsors
Chris O’Brien Lifehouse
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Written informed consent according to ICH/GCP regulations before registration. - Age 18 years or older - Histology of adenocarcinoma of the prostate - Ongoing treatment with androgen deprivation therapy (ADT) + androgen receptor pathway inhibitor (ARPI) [abiraterone, enzalutamide, apalutamide or darolutamide]. - Rising PSA (two consecutively rising PSA levels greater thab 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation - PSA doubling time greater than 8 weeks - Continuation of ongoing systemic treatment is deemed feasible by treating physician
Exclusion criteria
- Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments - Evidence of clinical progression or progression of disease on imaging - Bone metastases excluding the safety of physical exercise - Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures - Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure greater than 170 mm Hg or diastolic blood pressure greater than 105 mm Hg at screening) - Clinically significant chronic obstructive pulmonary disease (COPD) - Uncontrolled diabetes which, in the opinion of the investigator, interferes with the ability of the participant to complete the study - Chronic intake of corticosteroids (greater than 20 mg of prednisone per day) - Significant obesity (body mass index – BMI equal to or greater than 40) - Any concurrent disease or comorbid condition that interferes with the ability of the participant to complete the study
Outcome results
None listed