Prostate CancerZMoveMent-1NCT07126860
The Effect of a Structured Strength and Endurance Training Program on Quality of Life, Fitness, Blood Parameters and Survival in Prostate Cancer Patients
A study testing Structured combined resistance and aerobic training in people with Prostate Cancer and Metastatic Prostate Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer (Post Prostatectomy)
- What is being tested?
- Structured combined resistance and aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 24 May 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ludwig Maximilian University Hospital Campus Großhadern
Munich, Bavaria, 81377
About this study
Official title: ZMoveMent-1: Effect of a Resistance and Aerobic Training Intervention on Quality of Life, Fitness, Immunological Parameters, and Oncological Outcome in Patients With Prostate Cancer
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.
Read more
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.
Read the detailed description
This study is a two-arm open-label controlled trial that aims to investigate the effects of combined resistance and aerobic training on quality of life (QoL), body composition, fitness parameters, immunological parameters, and oncological outcomes in patients with prostate cancer (PC).
150 men will be recruited with either localized, locally advanced, or metastatic PC. Patients will be randomly assigned in a 2:1 ratio to either the intervention arm (guided home-based training) or the standard of care (SOC) arm (self-directed or no exercise). Prior to enrollment, participants will provide written informed consent, undergo clinical eligibility confirmation, and complete screening assessments. Owing to the already documented general health benefits of exercise in patients with PC, participants randomized to the SOC arm will be informed about the benefits of exercise as well, and will be motivated to engage in exercise under their own management (self-directed exercise). Changes in physical activity will be monitored in both groups.
This study will include a screening phase, a 12-week intervention phase, a post-12-week intervention phase, and a longer-term intervention phase.
During the screening phase (maximally 35 days prior to the first training session), participants will undergo assessments to determine their eligibility for the study. This involves evaluating inclusion and exclusion criteria, as well as data collection on demographics and tumor stage. To avoid bias and to ensure equal participation and motivation of participants from both the intervention and the SOC arm in the baseline tests, patient randomization will only take place after the baseline testing.
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 radical prostatectomy (RP) or completion of external-beam radiotherapy (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. The control arm will receive SOC without any exercise prescriptions. Throughout the phase, participants' physical activity will be monitored using regular questionnaires and wearable device data. Efficacy evaluations will be conducted at baseline and after the 12-week intervention phase.
The post-12-week intervention phase will follow the 12-week intervention phase and will last for 1 year. Throughout this phase, QoL, oncological outcomes, laboratory parameters, as well as ongoing physical activity will be assessed periodically.
The longer-term intervention phase will begin 1 year after completion of the 12-week intervention phase, and will continue until one of the following events occurs: death, loss to follow-up or withdrawal of consent, or end of the study, whichever occurs first. Throughout this phase, oncological outcomes will be assessed periodically.
The study population will consist of men diagnosed with localized, locally advanced, or metastatic PC. Participants with localized or locally advanced PC may be enrolled pre- or post- RP, or at any point before, during, or after EBRT. Training will then commence 4-8 weeks after completion of RP or EBRT. Participants with locally advanced, non-metastatic, and metastatic PC under systemic treatment and not undergoing local curatively intended treatment can be enrolled at any time under any treatment.
All measurements will be assessed at baseline (maximally 14 days prior to the first training session) and after the 12-week intervention phase. Additionally, laboratory parameters, patient-reported outcome (PRO) assessments, and wearable data assessments will be repeated 3, 6, and 12 months after completion of the 12-week intervention phase.
- Conditions
- Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer (Post Prostatectomy), Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer Non-Metastatic
- Being tested
- Structured combined resistance and aerobic training, Standard of Care
- 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
- Medical subject headings
- Prostatic Neoplasms, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured combined resistance and aerobic trainingBehavioural
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.
Standard of CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and after 12-week intervention phase
Change from Baseline in Serum Low-Density Lipoprotein (LDL) in milligrams/deciliter (mg/dl)
Measured: 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
The amount of MET-minutes in each GPAQ physical activity category (work, transport, leisure) will be reported.
Measured: 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)
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Adherence to the training program
Adherence will be assessed using different methods:
- Analysis of training platform: percentage of completed training sessions out of the total prescribed sessions
- Questionnaire: how many times per week and for how long (weeks) was the training program performed?
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Adverse Events by Questionnaire
AE (e.g., bone pain, path. skeletal fracture, musculoskeletal injury, joint pain, falls, muscle soreness) will be monitored via questionnaire, and incidence, severity, type, and attribution (exercise/disease) will be recorded as case report forms. CTCAE (Common Terminology Criteria for Adverse Events) will be used as the grading system for AE.
Measured: 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
Every subscale (urinary, bowel, sexual, hormonal) can range from 0-100. Higher scores mean higher QoL.
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the Short Form 36 (SF-36) Questionnaire Subscale Scores
Every subscale (physical functioning, role limitations due to physical health, role limitations due to emotional health, fatigue, emotional well-being, social functioning, pain, general health) can range from 0-100. Higher scores mean higher QoL.
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the International Index of Erectile Function (IIEF) Questionnaire Score
Score can range from 1-30. Higher score means better QoL (less erectile dysfunction).
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score
Score ranges from 0-21. Higher Score means worse sleep quality.
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the Decision Regret Scale (DRS) Questionnaire Score
Score ranges from 0-100. Higher score means higher regret (worse outcome).
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in bodyweight in kilograms (kg)
Measured: Baseline and after 12-week intervention phase
Change from baseline in body mass index (BMI) in kg/(m^2)
To calculate BMI, body weight in kg and body height in centimeters (cm) will be measured.
Measured: Baseline and after 12-week intervention phase
Change from baseline in hip- and waist circumference in cm
Measured: Baseline and after 12-week intervention phase
Change from baseline in muscle thickness (MT) at anterior upper arm, posterior upper arm, anterior thigh, and lateral thigh
Muscle Thickness will be measured via ultrasound (linear head held perpendicular to the skin) at 4 sites (anterior and posterior upper arm, anterior and lateral thigh). The measurement protocol used is adapted from Schoenfeld et al. (2019): https://doi.org/10.1249/MSS.0000000000001764
Measured: Baseline and after 12-week intervention phase
Change from baseline in Short Physical Performance Battery (SPPB) Test Score
The following SPPB data will be reported:
- Balance test score (range 0-4, higher score means better performance)
- 4 m gait speed test: score (range 0-4, higher score means better performance) and absolute time (in seconds)
- Chair rising test: score (range 0-4, higher score means better performance) and absolute time (in seconds)
- Overall score (0-12, higher score means better performance)
Measured: Baseline and after 12-week intervention phase
Change from baseline in Timed Up And Go Test (TUGT) in seconds
Measured: Baseline and after 12-week intervention phase
Change from baseline in grip strength test in newton/kilograms
Measured: Baseline and after 12-week intervention phase
Change from baseline in resting heart rate (RHR) in beats per minute (bpm), measured by wearable device
The mean RHR over the previous 14 days prior to the patient visit, as measured by the wearable device, will be reported.
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in daily step count in steps/day, measured by wearable device
The mean daily step count over the previous 14 days prior to the patient visit, as measured by the wearable device, will be reported.
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in daily caloric expenditure by activity in calories/day, measured by wearable device
The mean daily caloric expenditure by activity over the previous 14 days prior to the patient visit, as measured by the wearable device, will be reported.
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in daily sleep duration in hours (h), measured by wearable device
The mean daily sleep duration over the previous 14 days prior to the patient visit, as measured by the wearable device, will be reported.
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood glucose level in mg/dl
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood creatinine level in mg/dl
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood C-reactive protein (CRP) level in mg/dl
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood alcaline phosphatase (AP) level in units/liter (U/l)
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood lactate dehydrogenase (LDH) level in U/l
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood total cholesterole level in mg/dl
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood high-density lipoprotein (HDL) level in mg/dl
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood insulin-like growth factor (IGF-1) level in ng/ml
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood hemoglobin in grams/deciliter (g/dl)
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood white blood cell (WBC) count in giga/liter (G/l)
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood platelet count in G/l
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood prostate-specific antigen (PSA) level in ng/ml
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood testosterone level in ng/ml
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood sex-hormone binding globulin (SHBG) level in nanomole/liter (nmol/l)
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood interleukin-6 (IL-6) level in picogram/ml (pg/ml)
Measured: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start24 May 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimon Kempin, Ludwig-Maximilians - University of Munich
- Investigators
- Sabine Brookman-May, Professor, Dr. med., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126860
- Sponsor's protocol ID
- 23-0573
- Acronym
- ZMoveMent-1
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZMoveMent-1: Effect of a Resistance and Aerobic Training Intervention on Quality of Life, Fitness, Immunological Parameters, and Oncological Outcome in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT07126860
- Acronym / sponsor ID
- ZMoveMent-1 / 23-0573
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a two-arm open-label controlled trial that aims to investigate the effects of combined resistance and aerobic training on quality of life (QoL), body composition, fitness parameters, immunological parameters, and oncological outcomes in patients with prostate cancer (PC).
150 men will be recruited with either localized, locally advanced, or metastatic PC. Patients will be randomly assigned in a 2:1 ratio to either the intervention arm (guided home-based training) or the standard of care (SOC) arm (self-directed or no exercise). Prior to enrollment, participants will provide written informed consent, undergo clinical eligibility confirmation, and complete screening assessments. Owing to the already documented general health benefits of exercise in patients with PC, participants randomized to the SOC arm will be informed about the benefits of exercise as well, and will be motivated to engage in exercise under their own management (self-directed exercise). Changes in physical activity will be monitored in both groups.
This study will include a screening phase, a 12-week intervention phase, a post-12-week intervention phase, and a longer-term intervention phase.
During the screening phase (maximally 35 days prior to the first training session), participants will undergo assessments to determine their eligibility for the study. This involves evaluating inclusion and exclusion criteria, as well as data collection on demographics and tumor stage. To avoid bias and to ensure equal participation and motivation of participants from both the intervention and the SOC arm in the baseline tests, patient randomization will only take place after the baseline testing.
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 radical prostatectomy (RP) or completion of external-beam radiotherapy (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. The control arm will receive SOC without any exercise prescriptions. Throughout the phase, participants' physical activity will be monitored using regular questionnaires and wearable device data. Efficacy evaluations will be conducted at baseline and after the 12-week intervention phase.
The post-12-week intervention phase will follow the 12-week intervention phase and will last for 1 year. Throughout this phase, QoL, oncological outcomes, laboratory parameters, as well as ongoing physical activity will be assessed periodically.
The longer-term intervention phase will begin 1 year after completion of the 12-week intervention phase, and will continue until one of the following events occurs: death, loss to follow-up or withdrawal of consent, or end of the study, whichever occurs first. Throughout this phase, oncological outcomes will be assessed periodically.
The study population will consist of men diagnosed with localized, locally advanced, or metastatic PC. Participants with localized or locally advanced PC may be enrolled pre- or post- RP, or at any point before, during, or after EBRT. Training will then commence 4-8 weeks after completion of RP or EBRT. Participants with locally advanced, non-metastatic, and metastatic PC under systemic treatment and not undergoing local curatively intended treatment can be enrolled at any time under any treatment.
All measurements will be assessed at baseline (maximally 14 days prior to the first training session) and after the 12-week intervention phase. Additionally, laboratory parameters, patient-reported outcome (PRO) assessments, and wearable data assessments will be repeated 3, 6, and 12 months after completion of the 12-week intervention phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Training | Experimental | Behavioral: Structured combined resistance and aerobic trainingThe 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. |
| Standard of Care | Other | Behavioral: Standard of CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured combined resistance and aerobic trainingThe 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. | Behavioural | Structured Training |
| Standard of CareParticipants 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. | Behavioural | Standard of Care |
Primary outcome
Change from Baseline in the Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Score
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Range of 0-156 points. Higher points mean higher QoL.
Change from Baseline in Total Muscle Thickness (TMT)
Time frame: Baseline and after 12-week intervention phase
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
Change from Baseline in Serum Low-Density Lipoprotein (LDL) in milligrams/deciliter (mg/dl)
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
35 secondary outcomes
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
Time frame: 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)
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Adherence to the training program
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Adverse Events by Questionnaire
Time frame: 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
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the Short Form 36 (SF-36) Questionnaire Subscale Scores
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the International Index of Erectile Function (IIEF) Questionnaire Score
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from Baseline in the Decision Regret Scale (DRS) Questionnaire Score
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in bodyweight in kilograms (kg)
Time frame: Baseline and after 12-week intervention phase
Change from baseline in body mass index (BMI) in kg/(m^2)
Time frame: Baseline and after 12-week intervention phase
Change from baseline in hip- and waist circumference in cm
Time frame: Baseline and after 12-week intervention phase
Change from baseline in muscle thickness (MT) at anterior upper arm, posterior upper arm, anterior thigh, and lateral thigh
Time frame: Baseline and after 12-week intervention phase
Change from baseline in Short Physical Performance Battery (SPPB) Test Score
Time frame: Baseline and after 12-week intervention phase
Change from baseline in Timed Up And Go Test (TUGT) in seconds
Time frame: Baseline and after 12-week intervention phase
Change from baseline in grip strength test in newton/kilograms
Time frame: Baseline and after 12-week intervention phase
Change from baseline in resting heart rate (RHR) in beats per minute (bpm), measured by wearable device
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in daily step count in steps/day, measured by wearable device
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in daily caloric expenditure by activity in calories/day, measured by wearable device
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in daily sleep duration in hours (h), measured by wearable device
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood glucose level in mg/dl
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood creatinine level in mg/dl
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood C-reactive protein (CRP) level in mg/dl
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood alcaline phosphatase (AP) level in units/liter (U/l)
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood lactate dehydrogenase (LDH) level in U/l
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood total cholesterole level in mg/dl
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood high-density lipoprotein (HDL) level in mg/dl
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood insulin-like growth factor (IGF-1) level in ng/ml
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood hemoglobin in grams/deciliter (g/dl)
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood white blood cell (WBC) count in giga/liter (G/l)
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood platelet count in G/l
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood prostate-specific antigen (PSA) level in ng/ml
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood testosterone level in ng/ml
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood sex-hormone binding globulin (SHBG) level in nanomole/liter (nmol/l)
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Change from baseline in blood interleukin-6 (IL-6) level in picogram/ml (pg/ml)
Time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Brookman-May, Professor, Dr. med. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured combined resistance and aerobic training in people with Prostate Cancer and Metastatic Prostate Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Score (time frame: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.