High-impact exercise program for prostate cancer patients with bone metastases
High Impact Training to Patients with Prostate Cancer and Bone Metastases
This study is testing whether a high-impact exercise program can help men with prostate cancer that has spread to their bones feel better and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Copenhagen University Hospital at Herlev Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Herlev, Herlev) |
| Trial ID | NCT06259279 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a high-impact exercise program on patients with metastatic hormone-sensitive prostate cancer and bone metastases. Participants will engage in a 32-week, twice-weekly supervised exercise regimen that includes resistance training aimed at improving bone mineral density, physical function, and overall quality of life. The study will also assess the safety and feasibility of this exercise intervention, as well as its impact on antitumor immunity through blood samples and tumor biopsies. The initial phase focuses on adapting participants to the exercises before progressing to high-intensity training.
Who should consider this trial
Good fit: Ideal candidates are men with metastatic hormone-sensitive prostate cancer who have bone metastases and are undergoing androgen deprivation therapy.
Not a fit: Patients with significant physical conditions or musculoskeletal, cardiovascular, or neurological issues that prevent them from participating in exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance bone health, physical performance, and quality of life for prostate cancer patients with bone metastases.
How similar studies have performed: Previous studies have shown positive outcomes with exercise interventions in cancer patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with metastatic hormone sensitive prostate cancer (mHSPC) * Patients must have bone metastases according to the most recent imaging (Bone scan, CT, MRI and/or PET) * Patients must be treated with androgen deprivation therapy (ADT) (orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist or antagonist treatment) started \< 12 months ago. Additional treatment in the mHSPC setting, i.e., radiotherapy (RT) of the prostate, novel hormone agents (NHA) and/or docetaxel is permitted * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score \<2 * Patients must be able to speak and read Danish and provide a signed informed consent form * Patients must be ambulatory without walking aids Exclusion Criteria: * Patients with any physical condition that interferes with the performance of physical exercise training * Patients with presence of any musculoskeletal, cardiovascular, or neurologic conditions that may prevent patients from exercising * Patients with bone pain requiring opioids * Patients with planned or prior palliative radiation therapy to the bone * Patients with major surgery within the past 6 months HIPimmune: all patients included in HIP are eligible for HIPimmune
Where this trial is running
Herlev, Herlev
- Herlev and Gentofte Hospital — Herlev, Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Anne-Mette Ragle, PhD student — Copenhagen University Hospital at Herlev
- Study coordinator: Anne-Mette Ragle, PhD student
- Email: anne-mette.ragle@regionh.dk
- Phone: +4527128044
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.