Prostate CancerNCT05590624
Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer
A study testing Lower-Carbohydrate Med-t-Diet and Low-Fat Med-t-Diet in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer. The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Lower-Carbohydrate Med-t-Diet and Low-Fat Med-t-Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to Dec 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
- Males ≥18 years old
- High suspicion of prostate cancer (PCa) per urologist's clinical evaluation
- BMI >18.5
- No prior PCa diagnosis or hormonal therapy (-ies)
- Ability to read, write, speak, and understand English
- Ability to provide informed consent
Show all 9Show fewer
- Candidate for and elects active surveillance (AS) if diagnostic biopsy is positive
- Willingness to consume provided dietary interventions
- Adequate organ and marrow function: White blood cell count (WBC) ≥2,500/mcL, Absolute neutrophil count (ANC) ≥1,500/mcL, Platelets ≥100,000/mcL, Hemoglobin ≥9 g/dL (transfusions permitted), Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN) (for subjects with Gilbert's disease ≤3.0 mg/dL), Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN, Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation
Who cannot join
- Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber > per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators.
- Previous intolerability to fiber-rich diets
- Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion
- Unwilling to undergo transperineal PCa biopsies
- Food allergies or other major dietary restrictions
- Receiving active medical treatment for Type I or Type II diabetes mellitus
Show all 19Show fewer
- Prior antibiotic usage (i.e. within last 30 days) at time of consent
- Recent weight loss (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days
- Undergone any type of weight loss surgery
- Any medical contraindications as determined by investigators
- High risk as defined by PSA≥20 and/or PI-RADS 5 lesion as per clinician evaluation
- History of diabetic ketoacidosis
- Gout
- Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion
- Recent (within last 30 days) device implant/joint requiring antibiotics as per clinician determination
- Prior history of prostate biopsy infection
- Uncontrolled hypertension as defined by blood pressure greater than 140/80 (with or without medication)
- Gallbladder removed or plan to remove per clinician evaluation
- Other malignancies actively receiving systemic treatment as per clinician evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Myra Krnac, 216-444-1047, krnacm@ccf.org
About this study
Official title: Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer.
The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. More specifically, the suggested benefits of low carbohydrate and low fat diets in PCa are not determined.
Read the detailed description
Primary Objective
-Evaluate the impact of Mediterranean diets (Med-t-Diets) on non-malignant prostate tissue metabolism
Secondary Objectives
- Evaluate the impact of Med-t-Diets on host metabolism
- Evaluate the impact of Med-t-Diets on systemic biomarkers after consuming Med-t-Diets
- Evaluate the impact of Med-t-Diets on the microbiome and dietary behavior and compliance after consuming Med-t-Diets
- Conditions
- Prostate Cancer
- Being tested
- Lower-Carbohydrate Med-t-Diet, Low-Fat Med-t-Diet
- Keywords
- Mediterranean-type Diets
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower-Carbohydrate Med-t-DietOther
Diet will focus on including:
- Lean protein sources
- High-quality fat
- High-quality carbohydrate sources that are rich in fiber
- Nuts and seeds
Diet will focus on limiting:
- Refined sugars
- High glycemic carbohydrates
- Seed oils that may cause inflammation
Diet Composition: 45% fats, 35% carbs, 20% protein
Low-Fat Med-t-DietOther
Diet will focus on including:
- Lean protein sources
- High-quality fat
- High-quality carbohydrate sources that are rich in fiber
- Nuts and seeds
Diet will focus on limiting:
- Refined sugars
- High glycemic carbohydrates
- Seed oils that may cause inflammation
Diet Composition: 70% carbs, 20% protein, 10% fat
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean-type Diet(s)-Arm 1 | Experimental | Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after Receives: Other: Lower-Carbohydrate Med-t-Diet; Other: Low-Fat Med-t-Diet |
| Mediterranean-type Diet(s)-Arm 2 | Experimental | Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after. Receives: Other: Lower-Carbohydrate Med-t-Diet; Other: Low-Fat Med-t-Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
Change in non-malignant prostate tissue metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure.
Measured: Change from diagnostic biopsy (Week 2) at confirmatory biopsy
Secondary outcomes (14)
Changes in blood metabolomics
Change in blood metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure
Measured: Change from baseline at two weeks on diet
Changes in energy substrate(s)
Change measured by respiratory exchange ratio (VCO2/VO2) difference between baseline and at two weeks on diet
Measured: Change from baseline at two weeks on diet
Changes in blood glucose (mg/dL)
Change as measured by the difference between blood glucose levels at baseline and at week two on diet
Measured: Change from baseline at two weeks on diet
Changes in ketone levels (mM or mcg/mL)
Change measured by the difference between ketone levels between baseline and at two weeks on diet
Measured: Change from baseline at two weeks on diet
Changes in hemoglobin A1C (HbA1C) (%)
Change measured by the difference between A1C levels at baseline and at 2 weeks on diet
Measured: Change from baseline at two weeks on diet
Changes in C-reactive protein (CRP) (mg/L)
Change measured by the difference between CRP levels at baseline and at 2 weeks on diet
Measured: Change from baseline at two weeks on diet
Changes in lipid particle size (nm)
Change measured by the difference in lipid particle size at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR).
Measured: Change from baseline at two weeks on diet
Changes in lipid particle number (nmol/L and/or μmol/L)
Change measured by the difference in lipid particle number at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR)
Measured: Change from baseline at two weeks on diet
Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)]
Change as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score using fasting insulin and glucose from longitudinal blood specimens at baseline and at two weeks on diet. The HOMA-IR test tests how resistant a participant is to insulin. A score of less than 1 indicates that a participant is insulin-sensitive, a score greater than 1.9 indicates some insulin resistance, and a score greater than 2.9 indicates significant insulin resistance.
Measured: Change from baseline at two weeks on diet
Prostate health changes
As measured by changes in the Prostate Health Index
Measured: Change from baseline at two weeks on diet
Safety and tolerability of the diets
Safety and tolerability measured by the number of adverse events and by the gastric tolerance questionnaire
Measured: Through study completion, an average of 7.5 month
Changes in alpha and beta diversity of the gut microbiome
Changes measured by Shannon or Simpson diversity index (alpha diversity) and pairwise Bray-Curtis metric values (beta diversity)
Measured: Change from baseline at two weeks on diet
Changes in dietary behavior
Behavioral changes measured by validated 24 hour dietary recalls collected by trained dietetics personnel on 2 week days and 1 weekend to capture specific dietary information
Measured: Through study completion, an average of 7.5 months
Diet compliance
Compliance measured by >90% of provided calories consumed
Measured: throughout controlled feeding period(s), two weeks per diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start3 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomized to one of two arms which only differ in the order they will receive the two dietary interventions \[Lower Carbohydrate (LC) and Low Fat (LF)\]. All dietary interventions are on a Mediterranean foundation and are opposite in carbohydrate and fat content. Arm 1 \[n=15 with confirmed PCa diagnosis and candidate for Active Surveillance (AS) per Standard of Care (SOC)\]: Dietary Intervention #1=Low Fat (LF) Mediterranean. Dietary Intervention #2=Lower Carbohydrate (LC) Mediterranean Arm 2 (n=15 with confirmed PCa diagnosis and candidate for AS per SOC): Dietary Intervention #1=LC Mediterranean. Dietary Intervention #2=LF Mediterranean
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Weight, MD, Principal investigator, Center Director, Cleveland Clinic Urologic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590624
- Sponsor's protocol ID
- CASE4822
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freedland SJ, Howard L, Allen J, Smith J, Stout J, Aronson W, Inman BA, Armstrong AJ, George D, Westman E, Lin PH. A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial. Prostate Cancer Prostatic Dis. 2019 Sep;22(3):428-437. doi: 10.1038/s41391-019-0126-5. Epub 2019 Jan 21.
PubMed 30664736Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
PubMed 16094059
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
- ClinicalTrials.gov ID
- NCT05590624
- Acronym / sponsor ID
- CASE4822
- Conditions
- Prostate Cancer
- Keywords
- Mediterranean-type Diets
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Oct 2022 (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.
The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer.
The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. More specifically, the suggested benefits of low carbohydrate and low fat diets in PCa are not determined.
Detailed description
Primary Objective
-Evaluate the impact of Mediterranean diets (Med-t-Diets) on non-malignant prostate tissue metabolism
Secondary Objectives
- Evaluate the impact of Med-t-Diets on host metabolism
- Evaluate the impact of Med-t-Diets on systemic biomarkers after consuming Med-t-Diets
- Evaluate the impact of Med-t-Diets on the microbiome and dietary behavior and compliance after consuming Med-t-Diets
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of two arms which only differ in the order they will receive the two dietary interventions [Lower Carbohydrate (LC) and Low Fat (LF)]. All dietary interventions are on a Mediterranean foundation and are opposite in carbohydrate and fat content. Arm 1 [n=15 with confirmed PCa diagnosis and candidate for Active Surveillance (AS) per Standard of Care (SOC)]: Dietary Intervention #1=Low Fat (LF) Mediterranean. Dietary Intervention #2=Lower Carbohydrate (LC) Mediterranean Arm 2 (n=15 with confirmed PCa diagnosis and candidate for AS per SOC): Dietary Intervention #1=LC Mediterranean. Dietary Intervention #2=LF Mediterranean
| Arm | Type | Receives |
|---|---|---|
| Mediterranean-type Diet(s)-Arm 1 | Experimental | Other: Lower-Carbohydrate Med-t-Diet, Other: Low-Fat Med-t-DietDiet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after |
| Mediterranean-type Diet(s)-Arm 2 | Experimental | Other: Lower-Carbohydrate Med-t-Diet, Other: Low-Fat Med-t-DietDiet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males ≥18 years old
- High suspicion of prostate cancer (PCa) per urologist's clinical evaluation
- BMI >18.5
- No prior PCa diagnosis or hormonal therapy (-ies)
- Ability to read, write, speak, and understand English
Key exclusion criteria (19 listed)
- Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber > per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators.
- Previous intolerability to fiber-rich diets
- Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion
- Unwilling to undergo transperineal PCa biopsies
- Food allergies or other major dietary restrictions
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 |
|---|---|---|
| Lower-Carbohydrate Med-t-DietDiet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 45% fats, 35% carbs, 20% protein | Other | Mediterranean-type Diet(s)-Arm 1, Mediterranean-type Diet(s)-Arm 2 |
| Low-Fat Med-t-DietDiet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 70% carbs, 20% protein, 10% fat | Other | Mediterranean-type Diet(s)-Arm 1, Mediterranean-type Diet(s)-Arm 2 |
Primary outcome
Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
Time frame: Change from diagnostic biopsy (Week 2) at confirmatory biopsy
Change in non-malignant prostate tissue metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure.
14 secondary outcomes
Changes in blood metabolomics
Time frame: Change from baseline at two weeks on diet
Changes in energy substrate(s)
Time frame: Change from baseline at two weeks on diet
Changes in blood glucose (mg/dL)
Time frame: Change from baseline at two weeks on diet
Changes in ketone levels (mM or mcg/mL)
Time frame: Change from baseline at two weeks on diet
Changes in hemoglobin A1C (HbA1C) (%)
Time frame: Change from baseline at two weeks on diet
Changes in C-reactive protein (CRP) (mg/L)
Time frame: Change from baseline at two weeks on diet
Changes in lipid particle size (nm)
Time frame: Change from baseline at two weeks on diet
Changes in lipid particle number (nmol/L and/or μmol/L)
Time frame: Change from baseline at two weeks on diet
Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)]
Time frame: Change from baseline at two weeks on diet
Prostate health changes
Time frame: Change from baseline at two weeks on diet
Safety and tolerability of the diets
Time frame: Through study completion, an average of 7.5 month
Changes in alpha and beta diversity of the gut microbiome
Time frame: Change from baseline at two weeks on diet
Changes in dietary behavior
Time frame: Through study completion, an average of 7.5 months
Diet compliance
Time frame: throughout controlled feeding period(s), two weeks per diet
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 19 Feb 2026.
- Background: PubMed 30664736Freedland SJ, Howard L, Allen J, Smith J, Stout J, Aronson W, Inman BA, Armstrong AJ, George D, Westman E, Lin PH. A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial. Prostate Cancer Prostatic Dis. 2019 Sep;22(3):428-437. doi: 10.1038/s41391-019-0126-5. Epub 2019 Jan 21.
- Background: PubMed 16094059Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
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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.
Christopher Weight, MD principal investigator
Center Director, Cleveland Clinic Urologic Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower-Carbohydrate Med-t-Diet and Low-Fat Med-t-Diet in people with Prostate Cancer, run by Case Comprehensive 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 9 inclusion and 19 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 19 Feb 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?
Contact Myra Krnac (216-444-1047, krnacm@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism (time frame: Change from diagnostic biopsy (Week 2) at confirmatory biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590624, which also lists 2 linked publications.
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 19 Feb 2026.