An interventional study of Lifestyle intervention in Prostate Cancer, sponsored by Oncology Institute of Southern Switzerland. Recruiting at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Oncology Institute of Southern Switzerland · Not applicable, Interventional, and Other
Among 136 studies in Prostatic Neoplasms with a site in Switzerland — 40 open to participants now, 58 under way, 20 of them phase 3. Prostatic Neoplasms · Switzerland.
Among the 136 studies in Prostatic Neoplasms with a site in Switzerland, this one is the 87th largest by planned enrollment of the 107 interventional ones that give a count, is one of 6 that started in 2023, is one of 23 with no phase, reaches primary completion later than 17 of the 57 other live ones, and was the 98th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →40 of the 136 studies in Prostatic Neoplasms with a site in Switzerland are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Switzerland
Men only
AstraZeneca · Sites in Switzerland, United States, Austria and 18 more countries
Ages 18+ · Men only
Massimo Valerio · Sites in Switzerland
Ages 18+ · Men only
University of Zurich · Sites in Switzerland
Ages 18+ · Men only
University Hospital, Basel, Switzerland · Sites in Switzerland
Ages 50+ · Men only · Healthy volunteers
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
136 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 31 · Phase 3 43 · Phase 4 3
First in 1992; this study’s year is marked. 6 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 140 across the 107 interventional studies, 219 across the 28 observational. Of the 71 that completed or were terminated, 16 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
44 of 136 have an industry lead sponsor. The 10 most frequent:
Oncology Institute of Southern Switzerland is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
Oncology Institute of Southern Switzerland has 5 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
8 of the studies in Prostatic Neoplasms with a site in Switzerland that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03903835Phase 3Karolinska InstitutetProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | 2026-12 |
| NCT07455097Heinrich-Heine University, DuesseldorfCOMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) | 2026-12-31 |
| NCT05850182Oncology Institute of Southern SwitzerlandLifestyle Intervention in Patients With Metastatic Prostate Cancer | 2026-12-31 |
| NCT04543799Oncology Institute of Southern SwitzerlandEvaluation of Sleep Quality in Prostate Cancer Patients Undergoing Treatment With Hormonal Therapeutic Approaches and in Patients With Full-resected Early Breast Cancer | 2026-12-31 |
| NCT06776172University Hospital, Basel, SwitzerlandExtended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0. | 2027-02 |
Add all 8 to your calendar (.ics) → With an account.
Among the 136 studies in Prostatic Neoplasms with a site in Switzerland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.
Behavioral: Lifestyle intervention
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).
Patient initiation rate
Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
Time frame: 12 weeks
Patient retention rate
Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
Time frame: 12 weeks
Adherence to prescribed training program
Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
Time frame: 12 weeks
Adherence to prescribed dietary regimen
Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
Time frame: 12 weeks
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
Time frame: 24 weeks
Effect of lifestyle intervention on PSA levels
PSA doubling time calculated with the formula PSA doubling time = ln (2) / PSA Slope \[PSA Slope = (ln (PSA level 2) - ln (PSA level 1)) / Time (no. of months)\]
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 weeks
Effect of lifestyle intervention on time to subsequent treatment
Time to a subsequent line of treatment (in weeks)
Time frame: 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
Time frame: 8 weeks
Effect of lifestyle intervention on plasma immune signature
Concentration of inflammatory cytokines in the plasma of participating patients, change compared to baseline
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Dec 2026, 37 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 87. This study's planned 37 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oncology Institute of Southern Switzerland