The Effect of a Structured Strength and Endurance Training Program on Quality of Life, Fitness, Blood Parameters and Survival in Prostate Cancer Patients

NCT07126860 | Recruiting

• 1 other identifier: 23-0573
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the second most common cancer among men. Many patients experience a significantly reduced quality of life due to either the cancer itself or the side effects of treatment. These side effects can include tiredness, weight gain, loss of muscle and strength, bone weakness, depression, reduced sexual function, and increased risk of heart problems. A commonly used treatment called androgen deprivation therapy, which reduces the levels of male hormones, can make these symptoms worse. Previous research has shown that physical exercise-both strength training and endurance training-can help improve physical and mental well-being in men with prostate cancer. Regular exercise has also been shown to improve body composition, cardiovascular health, and reduce cancer-related fatigue. Some studies even suggest that exercise might support the immune system and slow down the progression of cancer. The aim of this clinical trial is to find out whether a specific combination of resistance and aerobic training can help improve quality of life and health outcomes in men with prostate cancer. The exercise program is designed to be performed at home using simple equipment like resistance bands and bodyweight exercises, along with high-intensity interval training for endurance. Participants are asked to train three to six days a week. 150 men with prostate cancer at various stages of the disease will be included. These men will be randomly divided into two groups: two-thirds will receive the exercise program (intervention group), and one-third will continue with their usual care without the program (control group). The initial training period lasts 12 weeks and will be repeated to ensure that all participants in the exercise group train for at least six months. After that, they will be encouraged to keep training on their own. The main goal of the study is to see if the exercise program leads to improvements in quality of life, physical fitness, body composition, and markers of immune function. It will also be analyzed how well the participants stick to the program, whether a longer training period has more benefits, how physically active the participants are overall, and how the program might affect other health and cancer-related outcomes. The underlying hypothesis is that a structured, home-based resistance and aerobic training program will improve quality of life, physical fitness, body composition, immune function, and possibly cancer-related outcomes in men with prostate cancer.

Conditions

Prostate Cancer; Metastatic Prostate Cancer; Prostate Cancer (Post Prostatectomy); Prostate Cancer Patients Treated by Radiotherapy; Prostate Cancer Non-Metastatic

Keywords

biomarkers; cardiovascular health; depression reduction; endurance training; resistance training; strength training; aerobic training; exercise intervention; fitness tests; functional capacity; mental health; muscle strength; physical activity; physical rehabilitation; prostate cancer; androgen deprivation therapy

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in the Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Score

  Range of 0-156 points. Higher points mean higher QoL.

  Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

• Change from Baseline in Total Muscle Thickness (TMT)

  Muscle Thickness (MT) will be measured via ultrasound (linear head held perpendicular to the skin) at 4 sites (anterior and posterior upper arm, anterior and lateral thigh). For the primary outcome, the sum of those 4 sites will be used (TMT), but the separate results will also be reported. The measurement protocol used is adapted from Schoenfeld et al. (2019): https://doi.org/10.1249/MSS.0000000000001764

  Baseline and after 12-week intervention phase

• Change from Baseline in Serum Low-Density Lipoprotein (LDL) in milligrams/deciliter (mg/dl)

  Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

Secondary Outcomes (35)

• Change from baseline in the Metabolic Equivalent of Task (MET)-minutes/week as reported by the World Health Organization (WHO) Global Physical Activity Questionnaire (GPAC) Questionnaire Score

  Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

• Change from Baseline in Blood Pressure (systolic and diastolic)

  Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

• Adherence to the training program

  Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

• Adverse Events by Questionnaire

  After 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

• Change from Baseline in the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Subscale Scores

  Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

Other Outcomes (8)

• Event-free survival

  5 years after completion of 12-week intervention phase

• Overall survival

  5 years after completion of 12-week intervention phase

• Patients with curative therapy: time until biochemical failure, metastasis-free survival

  5 years after completion of 12-week intervention phase

Study Arms (2)

Structured Training

EXPERIMENTAL

The 12-week intervention phase comprises the initial 12 weeks of a home-based combined resistance and aerobic training protocol for the intervention arm. Training will commence 8 weeks (when medically cleared, a reduction to minimally 4 weeks is possible) after RP or completion of EBRT, or any time for PC patients undergoing systemic treatment. As part of their visit for baseline testing, participants will be familiarized with the online platform incorporating the training program, including the correct execution of the exercises. In addition, the online platform includes demonstration videos of all exercises.

Behavioral: Structured combined resistance and aerobic training

Standard of Care

OTHER

The control arm will receive SOC, as well as a booklet with general information and guidelines about physical activity in prostate cancer patients, but without any specific exercise prescriptions.

Behavioral: Standard of Care

Interventions

Structured combined resistance and aerobic training BEHAVIORAL

The 12-week intervention phase comprises the initial 12 weeks of a home-based combined resistance and aerobic training protocol for the intervention arm. Training will commence 8 weeks (when medically cleared, a reduction to minimally 4 weeks is possible) after RP or completion of EBRT, or any time for PC patients undergoing systemic treatment. As part of their visit for baseline testing, participants will be familiarized with the online platform incorporating the training program, including the correct execution of the exercises. In addition, the online platform includes demonstration videos of all exercises. Detailed information about the training program will be available for patients and investigators via a website and smartphone application. Additionally, participants will receive a printed document explaining the training program, the repetitions in reserve (RIR) scale (Helms et al., 2016), and the online tool/app for tracking.

Structured Training

Standard of Care BEHAVIORAL

Participants randomized to the SOC arm will also be informed about the benefits of exercise and motivated to engage in exercise under their own management (self-directed exercise). They will receive a booklet with general information and guidelines about physical activity in prostate cancer patients, but without any specific exercise prescriptions.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have a histologically diagnosed adenocarcinoma of the prostate
• Participant has to be ≥ 18 years of age
• Participant must have either localized, locally advanced, or metastatic PC which has been treated or is planned to be treated either by RP, EBRT, androgen deprivation therapy (ADT), androgen receptor signaling inhibitor (ARSI), or any combination
• Participant must understand and remember the training regimen
• Participant must have a smartphone to connect a wearable device
• Participant must have a smartphone or computer to access the online platform
• Participant has to be able to speak, understand, and read German or English
• Participant must sign an informed consent form (ICF)

You may not qualify if:

• Cardiovascular/neurological/musculoskeletal comorbidities with contraindications for resistance or aerobic training
• High risk of pathological fracture due to unstable bone metastases (note: patients with bone metastasis are generally eligible for participation in the study and program as long as there is no acute high risk of fracture)
• Any condition for which it may not be in the best interest of the patient to participate in the study

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig Maximilian University Hospital Campus Großhadern

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Psychological Well-Being; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sabine Brookman-May, Professor, Dr. med.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benazir Enzinger, Dr. med.

CONTACT

+49 176 83497017; Benazir.Enzinger@med.uni-muenchen.de

Shimon Kempin, B.Sc., medical student

CONTACT

+49 176 93681553; s.kempin@campus.lmu.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 17, 2025
• Study Start: May 24, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)