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Search / Trial NCT06259279

High Impact Training to Patients with Prostate Cancer and Bone Metastases

Launched by COPENHAGEN UNIVERSITY HOSPITAL AT HERLEV · Feb 6, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Bone Metastases Exercise Bone Mineral Density Resistance And Impact Training Antitumor Immunity

ClinConnect Summary

This clinical trial, called "High Impact Training to Patients With Prostate Cancer and Bone Metastases," is studying how a special exercise program can help men with prostate cancer that has spread to their bones. The researchers want to see if this exercise is safe and if it can improve bone health, physical abilities, and overall quality of life for participants. They will also look at how the exercise affects falls and hospital stays.

To join this trial, participants need to be men aged 65 to 74 who have been diagnosed with a specific type of prostate cancer that has spread to their bones and are currently receiving hormone therapy. They should be able to walk without assistance and understand Danish to give their consent. Participants can expect to engage in brief, high-impact exercises designed to strengthen their bones and improve their health, along with regular check-ins to monitor their progress. This is a great opportunity for eligible men to potentially improve their health while contributing to important research.

Gender

MALE

Eligibility 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

About Copenhagen University Hospital At Herlev

Copenhagen University Hospital at Herlev is a leading academic medical center in Denmark, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous studies aimed at improving patient outcomes and advancing medical knowledge. With a strong commitment to ethical standards and patient safety, Copenhagen University Hospital at Herlev collaborates with researchers, healthcare professionals, and industry partners to explore new treatment modalities and enhance the standard of care across various medical fields.

Locations

Herlev, , Denmark

Patients applied

0 patients applied

Trial Officials

Anne-Mette Ragle, PhD student

Principal Investigator

Copenhagen University Hospital at Herlev

Peter B Østergren

Study Director

Peter Østergren

Katharina Leuchte, Dr. med.

Study Director

University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported