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New treatment option for Prostate Cancer
Official title Lifestyle Intervention in Patients With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT05850182
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
You likely can't join if
- 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...
- Clinically significant chronic obstructive pulmonary disease
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bellinzona, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bellinzona, Switzerland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.