Prostate CancerACTIDIET-PRONCT05850182
Lifestyle Intervention in Patients With Metastatic Prostate Cancer
A study testing Lifestyle intervention in people with Prostate Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
Trial summary
The proposed pilot study aims at determining the feasibility of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with prostate cancer under androgen deprivation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent according to ICH/GCP regulations before registration.
- Age ≥ 18 years
- Histology of adenocarcinoma of the prostate
- Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)
- Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation
- PSA doubling time > 8 weeks
- Continuation of ongoing systemic treatment is deemed feasible by treating physician
Who cannot join
- 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 > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening)
- Clinically significant chronic obstructive pulmonary disease
- Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, 6500
Ursula Vogl, MD, +41 91 811 84 63, ursula.vogl@eoc.ch
Luigi Tortola, PhD, +41 91 811 96 68, luigi.tortola@eoc.ch
About this study
Official title: A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study
The proposed pilot study aims at determining the feasibility of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with prostate cancer under androgen deprivation therapy.
Read the detailed description
Prostate cancer (PCa) is among the most frequent tumor types and is the second deadliest type of cancer in men.
PCa has a multifactorial aetiology; modifiable environmental factors, including diet and obesity, have been associated with prostate carcinogenesis. Furthermore, patients with PCa are treated with androgen deprivation therapy (ADT), which has negative effects on the cardiovascular system and body composition, particularly on the fat and muscle mass, bone health and psychological wellbeing.
Data in the current literature suggests that a lifestyle intervention e.g. with targeted and supervised exercise therapy or a dietary intervention with a prudent dietary patternmay positively influence the quality of life and the course of the disease of patients under ADT. However, conclusive data is missing.
The proposed pilot study aims at determining the feasibility and the effect of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with PCa under ADT.
- Conditions
- Prostate Cancer
- Being tested
- Lifestyle intervention
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
12-week lifestyle intervention including adherence to a personalized balanced dietary regimen (low total fat, low saturated fat, high ω3 fatty acids, optimized protein content, low simple sugars) combined with regular physical activity (including physiotherapy sessions and self-training).
| Study group | Role | What they receive |
|---|---|---|
| Arm treated with lifestyle intervention | Experimental | Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity. Receives: Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient initiation rate
Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
Measured: 12 weeks
Patient retention rate
Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
Measured: 12 weeks
Adherence to prescribed training program
Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
Measured: 12 weeks
Adherence to prescribed dietary regimen
Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
Measured: 12 weeks
Secondary outcomes (12)
Effect of lifestyle intervention on PSA progression
Percentage of PSA non-progressors (patients with <25% PSA rise compared to baseline) at weeks 8, 12 and 24
Measured: 24 weeks
Effect of lifestyle intervention on PSA levels
PSA doubling time calculated with the formula PSA doubling time = ln (2) / PSA Slope [PSA Slope = (ln (PSA level 2) - ln (PSA level 1)) / Time (no. of months)]
Measured: 24 weeks
Effect of lifestyle intervention on radiographic progression
Percentage of patients being free of radiographic progression according to PCWG3 at weeks 12 and 24
Measured: 24 weeks
Effect of lifestyle intervention on patient-reported quality of life
Change in patient-reported quality of life from baseline using Functional Assessment of Cancer Therapy - Prostate (FACT-P) scoring from baseline to weeks 8, 12 and 24
Measured: 24 weeks
Effect of lifestyle intervention on patient-reported fatigue
Change in patient-reported fatigue from baseline using FACIT Fatigue scoring from baseline to weeks 8, 12 and 24
Measured: 24 weeks
Effect of lifestyle intervention on time to subsequent treatment
Time to a subsequent line of treatment (in weeks)
Measured: 24 months
Effect of lifestyle intervention on plasma lipid signature
Concentration of individual lipid types in the plasma of participating patients, change compared to baseline
Measured: 8 weeks
Effect of lifestyle intervention on plasma immune signature
Concentration of inflammatory cytokines in the plasma of participating patients, change compared to baseline
Measured: 8 weeks
Effect of lifestyle intervention on microbiome composition
Differences in community diversity and/or abundance of specific bacterial taxa within the intestinal microbiome prior to or during the lifestyle intervention.
Measured: 8 weeks
Effect of lifestyle intervention on anthropometric variables
Measurement of patient height and body weight and calculation of body-mass index (BMI) at baseline, during and after the lifesyle intervention.
Measured: 24 weeks
Effect of lifestyle intervention on lean body mass
Measurement of the percentage of lean body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
Measured: 12 weeks
Effect of lifestyle intervention on fat body mass
Measurement of the percentage of fat body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start27 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850182
- Sponsor's protocol ID
- ACTIDIET-PRO
- Acronym
- ACTIDIET-PRO
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study
- ClinicalTrials.gov ID
- NCT05850182
- Acronym / sponsor ID
- ACTIDIET-PRO / ACTIDIET-PRO
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed pilot study aims at determining the feasibility of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with prostate cancer under androgen deprivation therapy.
Detailed description
Prostate cancer (PCa) is among the most frequent tumor types and is the second deadliest type of cancer in men.
PCa has a multifactorial aetiology; modifiable environmental factors, including diet and obesity, have been associated with prostate carcinogenesis. Furthermore, patients with PCa are treated with androgen deprivation therapy (ADT), which has negative effects on the cardiovascular system and body composition, particularly on the fat and muscle mass, bone health and psychological wellbeing.
Data in the current literature suggests that a lifestyle intervention e.g. with targeted and supervised exercise therapy or a dietary intervention with a prudent dietary patternmay positively influence the quality of life and the course of the disease of patients under ADT. However, conclusive data is missing.
The proposed pilot study aims at determining the feasibility and the effect of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with PCa under ADT.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Arm treated with lifestyle intervention | Experimental | Behavioral: Lifestyle interventionPatients with prostate cancer will receive a lifestyle intervention on diet and physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent according to ICH/GCP regulations before registration.
- Age ≥ 18 years
- Histology of adenocarcinoma of the prostate
- Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)
- Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation
Key exclusion criteria (7 listed)
- 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 > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention12-week lifestyle intervention including adherence to a personalized balanced dietary regimen (low total fat, low saturated fat, high ω3 fatty acids, optimized protein content, low simple sugars) combined with regular physical activity (including physiotherapy sessions and self-training). | Behavioural | Arm treated with lifestyle intervention |
Primary outcome
Patient initiation rate
Time frame: 12 weeks
Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
Patient retention rate
Time frame: 12 weeks
Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
Adherence to prescribed training program
Time frame: 12 weeks
Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
Adherence to prescribed dietary regimen
Time frame: 12 weeks
Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
12 secondary outcomes
Effect of lifestyle intervention on PSA progression
Time frame: 24 weeks
Effect of lifestyle intervention on PSA levels
Time frame: 24 weeks
Effect of lifestyle intervention on radiographic progression
Time frame: 24 weeks
Effect of lifestyle intervention on patient-reported quality of life
Time frame: 24 weeks
Effect of lifestyle intervention on patient-reported fatigue
Time frame: 24 weeks
Effect of lifestyle intervention on time to subsequent treatment
Time frame: 24 months
Effect of lifestyle intervention on plasma lipid signature
Time frame: 8 weeks
Effect of lifestyle intervention on plasma immune signature
Time frame: 8 weeks
Effect of lifestyle intervention on microbiome composition
Time frame: 8 weeks
Effect of lifestyle intervention on anthropometric variables
Time frame: 24 weeks
Effect of lifestyle intervention on lean body mass
Time frame: 12 weeks
Effect of lifestyle intervention on fat body mass
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Prostate Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ursula Vogl, MD (+41 91 811 84 63, ursula.vogl@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient initiation rate (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.