Cancer of ProstateDIRECTNCT06406803
The Impact of Physical Activity Versus Dietary Energy Restriction on Tumour and Muscle Protein Synthesis in Prostate Cancer Patients
A study testing Dietary energy restriction and Daily exercise in people with Cancer of Prostate, run by Maastricht University Medical Center at 1 site in Belgium.
Trial summary
Background: Prostate cancer is the second most common cancer and the fifth leading cause of death in men worldwide. Tumour growth is attributed to disproportionately greater protein synthesis rates relative to protein breakdown rates. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer of Prostate
- What is being tested?
- Dietary energy restriction and Daily exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Oct 2024to Feb 2026
- 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
- Diagnosed with prostate cancer (Stages I-III)
- Scheduled to undergo a prostatectomy
- BMI between 18.5-35 kg/m2
Who cannot join
- Receiving pre-operative chemo, hormonal, radio therapy
- Physically unable to perform the exercise program
- Performing >300 min of moderate-vigorous physical activity per week (e.g., running, road cycling, swimming).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Ziekenhuis
Hasselt
Dion Houtvast, +31 88 388 7278, dion.houtvast@maastrichtuniversity.nl
About this study
Official title: The Impact of Physical Activity Versus Dietary Energy Restriction on Prostate Tumour and Muscle Tissue Protein Synthesis in Vivo in Prostate Cancer Patients
Background: Prostate cancer is the second most common cancer and the fifth leading cause of death in men worldwide. Tumour growth is attributed to disproportionately greater protein synthesis rates relative to protein breakdown rates. Tumour protein synthesis is modulated by several factors, including energy availability, blood flow, and hormone concentrations (e.g., IGF-1). Lifestyle modifications are rapidly becoming recognized as important adjunct therapeutic approaches to slow cancer development and enhance treatment efficacy. Dietary energy restriction is a 30-50% reduction in food intake, which induces an energy deficit and has been shown to attenuate tumour growth in rodent models. Muscle mass often declines during cancer treatment and negatively impacts treatment success rates and recovery. One drawback to dietary energy restriction is that it may accelerate declines in skeletal muscle mass and strength in cancer patients. Exercise also induces an energy deficit by increasing energy expenditure. In addition, exercise alters blood flow and releases circulating molecules, which appear to lower tumour protein synthesis rates. Exercise increases muscle protein synthesis rates, which would provide further benefits to cancer patients by helping to maintain skeletal muscle mass. Despite their promising therapeutic properties, the clinical efficacy of dietary energy restriction and exercise has not been directly determined in vivo in cancer patients.
Hypothesis and Objectives: The objective of this study is to compare the impact of dietary energy restriction versus (isocaloric) daily exercise on muscle, prostate, and prostate tumour protein synthesis rates over a 7-day period in vivo in prostate cancer patients.
Read more
It is hypothesized that 1) dietary energy restriction will lower both prostate tumour and muscle tissue protein synthesis rates and that 2) daily exercise will lower prostate tumour protein synthesis rates but increase muscle protein synthesis rates in prostate cancer patients.
Setting and Methods: Forty-five prostate cancer patients scheduled to undergo radical prostatectomy will be randomly assigned to one of three groups. The first group will undergo 7 days of dietary energy restriction (40% less food intake). The second group will perform 7 days of daily exercise and mild dietary energy restriction resulting in a total energy deficit of 40%. The third group will follow their regular diet and physical activity (control group). The research team will provide all aspects of the intervention (standardized meals, personalized exercise supervision). Patients will ingest deuterium-labelled water (2H2O) throughout the intervention period. After 7 days, patients will undergo a radical prostatectomy, during which tumour tissue, skeletal muscle tissue, and blood will be collected. Deuterium (2H-alanine) incorporation into the tissue samples will be measured to assess prostate tumour and skeletal muscle tissue protein synthesis rates.
- Conditions
- Cancer of Prostate
- Being tested
- Dietary energy restriction, Daily exercise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary energy restrictionBehavioural
Patients enrolled in the dietary energy restriction group will reach an energy deficit of 40% only through reduced dietary intake.
Daily exerciseBehavioural
Patients in the daily exercise group will reach an energy deficit of 40% through reduced dietary intake and increased physical activity (exercise).
| Study group | Role | What they receive |
|---|---|---|
| Dietary energy restriction | Experimental | Not described Receives: Behavioral: Dietary energy restriction |
| Daily exercise | Experimental | Not described Receives: Behavioral: Daily exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour protein synthesis rates
Measured using the deuterated water (2H2O) method
Measured: 7 days pre-operatively
Muscle protein synthesis rates
Measured using the deuterated water (2H2O) method
Measured: 7 days pre-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start12 Oct 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ProstateStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406803
- Sponsor's protocol ID
- f/2023/047
- Acronym
- DIRECT
- Status last verified
- Jan 2026
- First submitted
- 2 May 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Activity Versus Dietary Energy Restriction on Prostate Tumour and Muscle Tissue Protein Synthesis in Vivo in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06406803
- Acronym / sponsor ID
- DIRECT / f/2023/047
- Conditions
- Cancer of Prostate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 9 May 2024 (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.
Background: Prostate cancer is the second most common cancer and the fifth leading cause of death in men worldwide. Tumour growth is attributed to disproportionately greater protein synthesis rates relative to protein breakdown rates. Tumour protein synthesis is modulated by several factors, including energy availability, blood flow, and hormone concentrations (e.g., IGF-1). Lifestyle modifications are rapidly becoming recognized as important adjunct therapeutic approaches to slow cancer development and enhance treatment efficacy. Dietary energy restriction is a 30-50% reduction in food intake, which induces an energy deficit and has been shown to attenuate tumour growth in rodent models. Muscle mass often declines during cancer treatment and negatively impacts treatment success rates and recovery. One drawback to dietary energy restriction is that it may accelerate declines in skeletal muscle mass and strength in cancer patients. Exercise also induces an energy deficit by increasing energy expenditure. In addition, exercise alters blood flow and releases circulating molecules, which appear to lower tumour protein synthesis rates. Exercise increases muscle protein synthesis rates, which would provide further benefits to cancer patients by helping to maintain skeletal muscle mass. Despite their promising therapeutic properties, the clinical efficacy of dietary energy restriction and exercise has not been directly determined in vivo in cancer patients.
Hypothesis and Objectives: The objective of this study is to compare the impact of dietary energy restriction versus (isocaloric) daily exercise on muscle, prostate, and prostate tumour protein synthesis rates over a 7-day period in vivo in prostate cancer patients.
It is hypothesized that 1) dietary energy restriction will lower both prostate tumour and muscle tissue protein synthesis rates and that 2) daily exercise will lower prostate tumour protein synthesis rates but increase muscle protein synthesis rates in prostate cancer patients.
Setting and Methods: Forty-five prostate cancer patients scheduled to undergo radical prostatectomy will be randomly assigned to one of three groups. The first group will undergo 7 days of dietary energy restriction (40% less food intake). The second group will perform 7 days of daily exercise and mild dietary energy restriction resulting in a total energy deficit of 40%. The third group will follow their regular diet and physical activity (control group). The research team will provide all aspects of the intervention (standardized meals, personalized exercise supervision). Patients will ingest deuterium-labelled water (2H2O) throughout the intervention period. After 7 days, patients will undergo a radical prostatectomy, during which tumour tissue, skeletal muscle tissue, and blood will be collected. Deuterium (2H-alanine) incorporation into the tissue samples will be measured to assess prostate tumour and skeletal muscle tissue protein synthesis rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary energy restriction | Experimental | Behavioral: Dietary energy restriction |
| Daily exercise | Experimental | Behavioral: Daily exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with prostate cancer (Stages I-III)
- Scheduled to undergo a prostatectomy
- BMI between 18.5-35 kg/m2
Key exclusion criteria (3 listed)
- Receiving pre-operative chemo, hormonal, radio therapy
- Physically unable to perform the exercise program
- Performing >300 min of moderate-vigorous physical activity per week (e.g., running, road cycling, swimming).
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 |
|---|---|---|
| Dietary energy restrictionPatients enrolled in the dietary energy restriction group will reach an energy deficit of 40% only through reduced dietary intake. | Behavioural | Dietary energy restriction |
| Daily exercisePatients in the daily exercise group will reach an energy deficit of 40% through reduced dietary intake and increased physical activity (exercise). | Behavioural | Daily exercise |
Primary outcome
Tumour protein synthesis rates
Time frame: 7 days pre-operatively
Measured using the deuterated water (2H2O) method
Muscle protein synthesis rates
Time frame: 7 days pre-operatively
Measured using the deuterated water (2H2O) method
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 16 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary energy restriction and Daily exercise in people with Cancer of Prostate, run by Maastricht University Medical Center at 1 site in Belgium.
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 3 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: looking for participants now, as of the sponsor's last update on 16 Jan 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 Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour protein synthesis rates (time frame: 7 days pre-operatively). The study lists 2 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 16 Jan 2026.