Low to Moderate Load Power Training for Men With Metastatic Prostate Cancer. (NCT07572760) | Clinical Trial Compass
RecruitingNot Applicable
Low to Moderate Load Power Training for Men With Metastatic Prostate Cancer.
Spain66 participantsStarted 2024-04-10
Plain-language summary
The goal of this clinical trial is to learn if a low to moderate load power training program is feasible and effective for improving fitness and quality of life of people with prostate cancer under androgen suppression therapy and bone or lymph node metastasis. The main questions it aims to answer are:
* Does a low to moderate load power training program improve quality of life in people with metastatic prostate cancer under androgen deprivation therapy?
* Does a low to moderate load power training program improve power, strength, endurance, and balance in people with metastatic prostate cancer under androgen deprivation therapy?
Researchers will compare the exercise program with routine care to see if power training works to improve common physical side effects of androgen suppression therapy in patients with metastatic prostate cancer.
Participants will:
* Participate in a supervised exercise program twice a week for 6 months or maintain routine care.
* Perform fitness tests and questionnaires about quality of life and mental health.
* Those who take part in the exercise program will also perform semi-structured in-depth interviews after the end of the program.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histopathologically confirmed diagnosis of prostate adenocarcinoma.
• Metastatic hormone-sensitive prostate cancer (mHSPC), defined as:
* Presence of metastases at initial diagnosis (synchronous mHSPC), or
* Development of metastatic disease following prior treatment with curative intent (surgery and/or radiotherapy) (metachronous mHSPC).
* Evidence of progression to castration-resistant prostate cancer (CRPC).
* Ongoing treatment with a doublet regimen consisting of standard androgen deprivation therapy (ADT) in combination with an androgen receptor signaling inhibitor (ARSI), initiated prior to study enrollment.
* Receipt of bone-protective therapy, including calcium and vitamin D supplementation in combination with bisphosphonates.
* Presence of metastatic involvement limited to bone and/or lymph nodes.
* Functionally independent in activities of daily living.
Exclusion Criteria:
* Evidence of visceral metastatic disease.
* Current or prior treatment with a triplet regimen that includes chemotherapy.
* History of pathological fracture.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health-related quality of life
Timeframe: From enrollment to the end of the exercise program at 6 months.