Clinical trial NCT05850182: Lifestyle Intervention in Patients With Metastatic Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient initiation rate
timeFrame: 12 weeks
measure: Patient retention rate
timeFrame: 12 weeks
measure: Adherence to prescribed training program
timeFrame: 12 weeks
measure: Adherence to prescribed dietary regimen
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of lifestyle intervention on PSA progression
timeFrame: 24 weeks
measure: Effect of lifestyle intervention on PSA levels
timeFrame: 24 weeks
measure: Effect of lifestyle intervention on radiographic progression
timeFrame: 24 weeks
measure: Effect of lifestyle intervention on patient-reported quality of life
timeFrame: 24 weeks
measure: Effect of lifestyle intervention on patient-reported fatigue
timeFrame: 24 weeks
measure: Effect of lifestyle intervention on time to subsequent treatment
timeFrame: 24 months
measure: Effect of lifestyle intervention on plasma lipid signature
timeFrame: 8 weeks
measure: Effect of lifestyle intervention on plasma immune signature
timeFrame: 8 weeks
measure: Effect of lifestyle intervention on microbiome composition
timeFrame: 8 weeks
measure: Effect of lifestyle intervention on anthropometric variables
timeFrame: 24 weeks
measure: Effect of lifestyle intervention on lean body mass
timeFrame: 12 weeks
measure: Effect of lifestyle intervention on fat body mass
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
Study officials:
References: