AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
  • Jessa Ziekenhuis

    Hasselt

    Dion Houtvast, +31 88 388 7278, dion.houtvast@maastrichtuniversity.nl

    Recruiting

Other trials in Belgium

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.

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 groups in NCT06406803
Study groupRoleWhat they receive
Dietary energy restrictionExperimentalNot described
Receives: Behavioral: Dietary energy restriction
Daily exerciseExperimentalNot described
Receives: Behavioral: Daily exercise
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumour protein synthesis rates

    Measured using the deuterated water (2H2O) method

    Measured: 7 days pre-operatively

  2. 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.

  1. First posted9 May 2024
  2. Study start12 Oct 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in