Prostate AdenocarcinomaNCT04985565
Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
A study testing Dietary Intervention and Radical Prostatectomy in people with Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies the effects of a dietary intervention prior to surgery (neoadjuvant) in patients with intermediate risk prostate cancer. Changing your diet before surgery may help to improve overall health. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- Dietary Intervention and Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 20 Oct 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 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate that is localized based on prostate magnetic resonance imaging (MRI) and meets National Comprehensive Cancer Network (NCCN) intermediate risk criteria (as follows):
- Clinical T2b-T2c or lower disease
- Gleason Grade group 2 or 3 on biopsy
- Prostate specific antigen (PSA) =< 20 ng/mL
- Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist
- Adult men > 30 and < 75 years old (African American or non-Hispanic white)
Show all 12Show fewer
- Meet one of the following criteria for overweight or obesity:
- Body Mass Index (BMI) between 26 and 39
- Waist circumference >= 40 inches
- Willingness to exclusively consume all the provided meals
- Willingness to comply with all study procedures and scheduled visits
- Reside in the greater Houston/outlying areas and/or willing to travel for study-related visits at MD Anderson
Who cannot join
- Major dietary restrictions or food allergies
- Food aversions or preferences that preclude following a Mediterranean diet, such as unwillingness to eat vegetables, grains, animal products or fish
- Medical contraindications to the intervention diet as determined by the treating physician
- Current self-reported smoker or heavy drinker (defined as >14 drinks per week) or current self-reported illicit drug use
- Prostate cancer that meets NCCN high and very high risk criteria (as follows):
- pT3a or higher disease
- Grade group 4 or 5 adenocarcinoma of prostate
- PSA > 20ng/mL
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial studies the effects of a dietary intervention prior to surgery (neoadjuvant) in patients with intermediate risk prostate cancer. Changing your diet before surgery may help to improve overall health. Information from this study may help researchers better understand the influence of diet on the outcomes of patients with intermediate prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of a neoadjuvant feeding study prior to radical prostatectomy in a racially diverse group of men diagnosed with intermediate risk prostate cancer, defined as the percentage of patients who enter the pre-intervention equilibration period and begin the dietary intervention.
SECONDARY OBJECTIVES:
- Determine the tolerance of Mediterranean diet as defined by compliance with diet of 70% or greater total calories consumed during study period from the Mediterranean diet.
II. Determine the effects of controlled dietary interventions on metabolic parameters.
III. Determine the total number of potentially eligible patients who are approached by study coordinators and enter the equilibration period.
IV. Determine the effects of controlled dietary interventions on the fecal microbiome.
- Create a well annotated bank of clinical data and samples, including but not limited to periprostatic fat, for use in future research and analysis.
VI. Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer.
VII. Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption.
VIII. Compare Cav-1-sphingolipid levels following dietary interventions in with a separate cohort of men who do not undergo pre-operative dietary intervention.
OUTLINE:
Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
After completion of study treatment, patients are followed up at 4-8 weeks.
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
- Being tested
- Dietary Intervention, Radical Prostatectomy
- 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 InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Participate in Mediterranean diet
Radical ProstatectomyProcedure or surgery
Also called Prostatovesiculectomy
Undergo standard of care radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (dietary intervention, radical prostatectomy) | Experimental | Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy. Receives: Other: Dietary Intervention; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Feasibility is defined as >= 25% of patients who enter the equilibration period initiating the dietary intervention.
Measured: Up to 1 year from site initiation
Secondary outcomes (7)
Tolerance of Mediterranean diet
Defined as compliance of 70% or greater total caloric intake consumed from the provided Mediterranean diet meals. Will estimate the number of patients that were compliant along with the 95% confidence intervals.
Measured: Up to 1 year
The effects of controlled dietary interventions on metabolic parameters
As measured using metabolomics (Cav-1-signature score) and nuclear magnetic resonance (NMR) spectroscopy (using Nightingale platform). Paired t-test will be used to compare the metabolic parameters changes (pre- and post- dietary intervention) in untargeted mass spectrometry-based metabolite levels and NMR-based metabolite levels.
Measured: Up to 1 year
The effects of controlled dietary interventions on the fecal microbiome
Exploratory analysis using microbiome core. Fecal microbiome samples will be summarized using alpha diversity, computed using the inverse Simpson index, which can then be compared across time points using a paired t-test.
Measured: Up to 1 year
Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis
Anticipate 100% participation in patients who enroll and complete diet intervention.
Measured: Up to 1 year
Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer percentage of severe adverse reactions in patients completing the diet.
Measured: Up to 1 year
Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption
Will compare the baseline Cav-1-signature score levels with the post-diet (day of surgery) levels using paired t-tests. This evaluation is exploratory in nature and will be used to guide power calculations for future studies.
Measured: Up to 1 year
Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention
Will use a two-sample t-test to compare the levels of Cav-1-sphingolipid signature score in men who undergo a dietary intervention in this protocol with subjects enrolled under the separate protocol (protocol 2020-0828, "Diet, Biomarker, and Tissue Assessment in Intermediate Risk Prostate Cancer").
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start27 Aug 2021
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Justin R Gregg, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985565
- Sponsor's protocol ID
- 2020-0673
- Other IDs
- NCI-2021-02022, 2020-0673, P50CA140388
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT04985565
- Acronym / sponsor ID
- 2020-0673
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 2 Aug 2021 (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.
This clinical trial studies the effects of a dietary intervention prior to surgery (neoadjuvant) in patients with intermediate risk prostate cancer. Changing your diet before surgery may help to improve overall health. Information from this study may help researchers better understand the influence of diet on the outcomes of patients with intermediate prostate cancer.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of a neoadjuvant feeding study prior to radical prostatectomy in a racially diverse group of men diagnosed with intermediate risk prostate cancer, defined as the percentage of patients who enter the pre-intervention equilibration period and begin the dietary intervention.
SECONDARY OBJECTIVES:
- Determine the tolerance of Mediterranean diet as defined by compliance with diet of 70% or greater total calories consumed during study period from the Mediterranean diet.
II. Determine the effects of controlled dietary interventions on metabolic parameters.
III. Determine the total number of potentially eligible patients who are approached by study coordinators and enter the equilibration period.
IV. Determine the effects of controlled dietary interventions on the fecal microbiome.
- Create a well annotated bank of clinical data and samples, including but not limited to periprostatic fat, for use in future research and analysis.
VI. Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer.
VII. Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption.
VIII. Compare Cav-1-sphingolipid levels following dietary interventions in with a separate cohort of men who do not undergo pre-operative dietary intervention.
OUTLINE:
Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
After completion of study treatment, patients are followed up at 4-8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (dietary intervention, radical prostatectomy) | Experimental | Other: Dietary Intervention, Procedure: Radical ProstatectomyPatients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed adenocarcinoma of the prostate that is localized based on prostate magnetic resonance imaging (MRI) and meets National Comprehensive Cancer Network (NCCN) intermediate risk criteria (as follows):
- Adult men > 30 and < 75 years old (African American or non-Hispanic white)
- Meet one of the following criteria for overweight or obesity:
- Willingness to exclusively consume all the provided meals
- Willingness to comply with all study procedures and scheduled visits
Key exclusion criteria (8 listed)
- Major dietary restrictions or food allergies
- Food aversions or preferences that preclude following a Mediterranean diet, such as unwillingness to eat vegetables, grains, animal products or fish
- Medical contraindications to the intervention diet as determined by the treating physician
- Current self-reported smoker or heavy drinker (defined as >14 drinks per week) or current self-reported illicit drug use
- Prostate cancer that meets NCCN high and very high risk criteria (as follows):
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 InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsParticipate in Mediterranean diet | Other | Treatment (dietary intervention, radical prostatectomy) |
| Radical ProstatectomyAlso: ProstatovesiculectomyUndergo standard of care radical prostatectomy | Procedure or surgery | Treatment (dietary intervention, radical prostatectomy) |
Primary outcome
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Time frame: Up to 1 year from site initiation
Feasibility is defined as >= 25% of patients who enter the equilibration period initiating the dietary intervention.
7 secondary outcomes
Tolerance of Mediterranean diet
Time frame: Up to 1 year
The effects of controlled dietary interventions on metabolic parameters
Time frame: Up to 1 year
The effects of controlled dietary interventions on the fecal microbiome
Time frame: Up to 1 year
Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis
Time frame: Up to 1 year
Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer percentage of severe adverse reactions in patients completing the diet.
Time frame: Up to 1 year
Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption
Time frame: Up to 1 year
Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention
Time frame: Up to 1 year
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 18 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Justin R Gregg principal investigator
M.D. Anderson Cancer Center
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 Intervention and Radical Prostatectomy in people with Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
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 12 inclusion and 8 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 18 Sep 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 United States. 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?
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease (time frame: Up to 1 year from site initiation). 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 18 Sep 2026.