High Impact Training to Patients with Prostate Cancer and Bone Metastases

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

HIP is a randomized controlled trial. The aim is investigate the effect, safety and feasibility of brief, high-impact exercise targeting bones in patients with prostate cancer and bone metastases. Furthermore, to investigate the effects of the intervention on bone status (bone mineral density) and body composition, physical function and performance, patient reported quality-of-life outcomes, falls and hospitalizations. The effects of resistance training on the antitumor immunity will be assessed in the peripheral blood and tumor biopsies (HIPimmune).

Key facts

Study ID

NCT06259279

Run by

Copenhagen University Hospital at Herlev

People needed

102

Starts

2024-02-06

Expected to finish

2026-12-31

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Herlev and Gentofte Hospital — Herlev, Herlev, Denmark (enrolling)

Full record on ClinicalTrials.gov

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