High-impact exercise program for prostate cancer patients with bone metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.