Clinical trial · Interventional
Lifestyle Intervention in Patients With Metastatic Prostate Cancer
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
NCT05850182CI-TRIAL-00097401ACTIDIET-PROrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm treated with lifestyle intervention
- description
- Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.
- interventionNames
- Behavioral: Lifestyle intervention
Primary outcomes (4)
- measure
- Patient initiation rate
- timeFrame
- 12 weeks
- description
- Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
- measure
- Patient retention rate
- timeFrame
- 12 weeks
- description
- Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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 \> 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
References
Publications (0)
Data not yet available
No reference posted for this study.