High Impact Training to Patients with Prostate Cancer and Bone Metastases

NCT ID: NCT06259279

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-06
• Study Completion Date: 2026-12-31

Brief Summary

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).

Detailed Description

Participants assigned to the intervention group will participate in a 32-week, twice-weekly, 30-minute, supervised HIP program at the hospital in Herlev, Denmark. To ensure a safe transition to high-intensity exercise, the first eight weeks of the intervention includes self-bodyweight and low-impact variations with a focus on getting used to use weight training equipment and gradually learning the movement patterns of the HIP exercises. All participants should be able to perform the four basic exercises of the intervention within two months. The resistance exercises (deadlift, overhead press, and squats) will be performed in five sets of five repetitions for the remaining intervention period, maintaining an intensity of > 80% to 85% of 1 repetition maximum (RM). Blood samples and tumor biopsies will be taken at different timepoints of the exercise intervention (HIPimmune) and analyzed for lymphocyte entitumor responses.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Patients in the intervention group will receive a 32-week exercise-based intervention that includes supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.

Group Type: EXPERIMENTAL

High intensity high impact exercise intervention

Intervention Type: BEHAVIORAL

Patients in the intervention group will receive a 32-week exercise-based intervention that includes:

• Supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.

Control Group

standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High intensity high impact exercise intervention

Patients in the intervention group will receive a 32-week exercise-based intervention that includes:

• Supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: lead

Responsible Party

Anne-Mette Ragle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne-Mette Ragle, PhD student

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital at Herlev

Peter B Østergren

Role: STUDY_DIRECTOR

Peter Østergren

Katharina Leuchte, Dr. med.

Role: STUDY_DIRECTOR

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

Locations

Herlev and Gentofte Hospital

Herlev, Herlev, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anne-Mette Ragle, PhD student

Role: CONTACT

anne-mette.ragle@regionh.dk

+4527128044

Peter Busch Østergren, MD, PhD

Role: CONTACT

peter.busch.oestergren@regionh.dk

Facility Contacts

Anne-Mette Ragle, PhD student

Role: primary

anne-mette.ragle@regionh.dk

+4527128044

Peter B Østergren, MD PhD

Role: backup

peter.busch.oestergren@regionh.dk

References

Ragle AM, Mikkelsen MK, Vinther A, Zerahn B, Bogh Juhl C, Theile S, Madsen K, Nielsen DL, Ostergren PB. High-intensity resistance and impact training for patients with hormone-sensitive prostate cancer and bone metastases-study protocol of a randomized clinical trial. Trials. 2025 Jul 28;26(1):259. doi: 10.1186/s13063-025-08937-0.

Reference Type: DERIVED

PMID: 40722114 (View on PubMed)

Other Identifiers

AMRagle

Identifier Type: -

Identifier Source: org_study_id