Low-to-moderate load power and strength training for men with metastatic prostate cancer
Low to Moderate Load Power Training as an Exercise Intervention for Men With Metastatic Prostate Cancer Undergoing Androgen Deprivation Therapy.
This trial will test whether a twice-weekly, supervised low-to-moderate load power training program can improve fitness and quality of life for men with metastatic prostate cancer who are on androgen deprivation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | University of Alicante Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (San Vicent del Raspeig, Alicante) |
| Trial ID | NCT07572760 on ClinicalTrials.gov |
What this trial studies
Men with metastatic prostate adenocarcinoma who are functionally independent and receiving ADT plus an ARSI are assigned to either a supervised exercise program twice weekly for six months or to routine care. The intervention uses low-to-moderate loads focused on power, strength, endurance, and balance, with adaptations made to protect sites of bone or lymph node metastasis. Outcomes include patient-reported health-related quality of life and objective tests of power, strength, endurance, and balance performed at baseline and after the intervention. Safety monitoring and bone-protective measures are integrated throughout the program.
Who should consider this trial
Good fit: Ideal candidates are functionally independent men with histologically confirmed metastatic prostate adenocarcinoma limited to bone and/or lymph nodes who are on ADT combined with an ARSI and receiving bone-protective therapy.
Not a fit: Patients with visceral metastatic disease, significant functional dependence, or those not receiving the specified systemic and bone-protective therapies are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve muscle strength, physical function, and overall quality of life for men on ADT with bone or lymph node metastases.
How similar studies have performed: Related resistance and power training programs have shown benefits for strength and quality of life in men on ADT, but supervised low-to-moderate power training specifically in men with metastatic bone or nodal disease has been less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Vicent del Raspeig, Alicante
- University of Alicante — San Vicent del Raspeig, Alicante, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.