Low to Moderate Load Power Training for Men With Metastatic Prostate Cancer.
Recruiting · NCT07572760 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- University of Alicante - San Vicent del Raspeig, Alicante, Spain