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Trial Title:
Lifestyle Intervention in Patients With Metastatic Prostate Cancer
NCT ID:
NCT05850182
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Pilot study
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Lifestyle intervention
Description:
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).
Arm group label:
Arm treated with lifestyle intervention
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology Institute of Southern Switzerland (IOSI)
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Ursula Vogl, MD
Phone:
+41 91 811 84 63
Email:
ursula.vogl@eoc.ch
Contact backup:
Last name:
Luigi Tortola, PhD
Phone:
+41 91 811 96 68
Email:
luigi.tortola@eoc.ch
Start date:
November 27, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Oncology Institute of Southern Switzerland
Agency class:
Other
Source:
Oncology Institute of Southern Switzerland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05850182
