Mediterranean Diets for Prostate Cancer

Overseen By Myra Krnac

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Supplements, Vitamins

Disqualifiers: Diabetes, Hypertension, Gout, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking supplements, vitamins, or minerals that could interfere with the diets being tested, you may need to stop those. It's best to discuss your specific medications with the trial investigators.

What safety data exists for the Mediterranean Diet in treating prostate cancer?

The provided research does not directly address safety data for the Mediterranean Diet in treating prostate cancer. However, it suggests that adherence to the Mediterranean Diet is associated with lower prostate cancer incidence and mortality, particularly in Southern European countries. The studies focus on the diet's potential benefits and its association with reduced cancer aggressiveness, but they do not provide specific safety data. Further large-scale studies are recommended to clarify the diet's effects on prostate health. ^{1 2 3 4 5}

Is the Lower-Carbohydrate Med-t-Diet, Low-Fat Med-t-Diet a promising treatment for prostate cancer?

Yes, the Lower-Carbohydrate Med-t-Diet, Low-Fat Med-t-Diet is promising for prostate cancer. Studies show that the Mediterranean diet, which this treatment is based on, is linked to lower prostate cancer risk and mortality, especially in Southern European countries. It has anti-inflammatory and cancer-preventive properties, which may help slow down the progression of prostate cancer. ^{1 2 3 5 6}

What data supports the idea that Mediterranean Diets for Prostate Cancer is an effective treatment?

The available research shows that the Mediterranean Diet may help men with prostate cancer, especially those on active surveillance, due to its anti-inflammatory and protective properties. One study found that men who followed this diet had a lower risk of their cancer getting worse. Another study suggested that low-carbohydrate diets, which are similar to the Mediterranean Diet, might help slow down the disease. While not all studies showed a direct link to stopping cancer progression, the Mediterranean Diet is known for its overall health benefits, making it a good choice for men with prostate cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Christopher Weight, MD

Principal Investigator

Center Director, Cleveland Clinic Urologic Oncology

Are You a Good Fit for This Trial?

Men over 18 with a high suspicion of prostate cancer, as determined by a urologist, can join this trial. They must have a BMI over 18.5, no prior prostate cancer diagnosis or hormone treatments, and be able to understand English. Participants should be candidates for active surveillance if diagnosed and willing to eat specific diets provided in the study.

Inclusion Criteria

BMI >18.5

My urologist suspects I have prostate cancer.

Ability to read, write, speak, and understand English

Exclusion Criteria

I am currently being treated for diabetes.

I have lost more than 5% of my body weight in the last month.

My prostate cancer is high risk with a PSA over 20 or a PI-RADS 5 lesion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Diet Randomization and Initial Dietary Intervention

Participants are randomized to either a Low Fat or Lower Carbohydrate Mediterranean Diet two weeks prior to the Standard of Care diagnostic biopsy.

2 weeks

1 visit (in-person)

Crossover Dietary Intervention

If diagnosed with Prostate Cancer and eligible for Active Surveillance, participants undergo a washout period and crossover to the alternate diet two weeks prior to the confirmatory biopsy.

2 weeks

1 visit (in-person)

Long-term Follow-up

A long-term follow-up visit occurs 3 months after the second dietary intervention has concluded.

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lower-Carbohydrate Med-t-Diet
• Low-Fat Med-t-Diet

Trial Overview The study is testing how two types of Mediterranean-type diets affect metabolism in men with localized prostate cancer: one diet is lower in carbohydrates while the other is low-fat. The goal is to determine which dietary approach might benefit these patients more.

How Is the Trial Designed?

Group I: Mediterranean-type Diet(s)-Arm 2 Experimental Treatment 2 Interventions

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.

Group II: Mediterranean-type Diet(s)-Arm 1 Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

In a study of 47,867 men followed from 1986 to 2010, adherence to the traditional Mediterranean diet (Med-Diet) was not linked to a reduced risk of advanced or lethal prostate cancer (PCa).

However, among men diagnosed with nonmetastatic PCa, greater adherence to the Med-Diet after diagnosis was associated with a 22% lower risk of overall mortality, suggesting potential benefits for survival rather than disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and prostate cancer risk and mortality in the Health Professionals Follow-up Study. Kenfield, SA., DuPre, N., Richman, EL., et al.[2021]

A 6-month randomized trial involving 45 patients with biochemical recurrence of prostate cancer showed that a low-carbohydrate diet (LCD) led to significant weight loss and metabolic improvements without adversely affecting PSA doubling time (PSADT), which remained similar between the LCD and control groups.

Exploratory analysis suggested that the LCD may actually be associated with a longer PSADT (28 months) compared to the control group (13 months), indicating potential benefits for disease progression that warrant further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Freedland, SJ., Allen, J., Jarman, A., et al.[2022]

In a study of 410 men with localized prostate cancer on active surveillance, higher adherence to the Mediterranean diet was linked to a lower risk of progression in Gleason scores, suggesting potential benefits for cancer management.

The protective effect of the Mediterranean diet was particularly strong in non-White men and those without diabetes, indicating that dietary factors may play a significant role in cancer progression among different demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet and grade group progression in localized prostate cancer: An active surveillance cohort. Gregg, JR., Zhang, X., Chapin, BF., et al.[2023]

Men with prostate cancer can successfully adhere to a low-fat diet (15% fat or less) for 12 months when provided with proper nutritional counseling, as shown by significant reductions in fat intake and weight loss.

Participants receiving low-fat dietary counseling lost an average of 2.8 kg over 12 months, while those not receiving counseling gained weight, indicating the effectiveness of dietary guidance in managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a low-fat diet in men with prostate cancer. Link, LB., Thompson, SM., Bosland, MC., et al.[2013]

In a study of 564 men with localized prostate cancer under active surveillance, following specific dietary patterns like the Healthy Eating Index (HEI)-2015, Mediterranean Diet (aMED), or DASH did not significantly reduce the risk of disease progression as measured by Gleason score increases over a median follow-up of 7.8 years.

Despite not showing a direct impact on prostate cancer progression, these dietary patterns are still beneficial for overall health and may help prevent other chronic diseases, making them a good choice for men with prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Patterns and Risk of Gleason Grade Progression among Men on Active Surveillance for Prostate Cancer: Results from the Canary Prostate Active Surveillance Study. Schenk, JM., Liu, M., Neuhouser, ML., et al.[2023]

In a study of a Spanish population, adherence to the Mediterranean Diet (MeDi) did not show significant differences in overall prostate cancer (PCa) incidence, but a high intake of fruits, vegetables, and cooked tomato sauce was linked to less aggressive forms of PCa.

While the overall adherence to MeDi was similar between PCa patients and controls, the diet was associated with lower aggressiveness of tumors as measured by the Gleason score, suggesting potential protective effects that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet and risk of prostate cancer. Urquiza-Salvat, N., Pascual-Geler, M., Lopez-Guarnido, O., et al.[2019]

Adherence to a Mediterranean Diet is associated with lower overall mortality in patients diagnosed with nonmetastatic prostate cancer, suggesting potential benefits after diagnosis.

While there is strong evidence linking Mediterranean dietary components to reduced prostate cancer risk, current studies do not consistently support a direct association between adherence to this diet and lower incidence or progression of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet adherence and prostate cancer risk. López-Guarnido, O., Álvarez-Cubero, MJ., Saiz, M., et al.[2016]

In a study of 777 men with prostate cancer, those who adhered to the Mediterranean diet (MDS ≥ 5) had a 26% lower risk of overall death compared to those with lower adherence (MDS < 5).

Combining high adherence to the Mediterranean diet with high physical activity further reduced the risk of all-cause death, highlighting the importance of diet and exercise in improving overall survival for men with prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean Diet, Physical Activity and Survival after Prostate Cancer Diagnosis. Di Maso, M., Augustin, LSA., Toffolutti, F., et al.[2021]

Selenium shows the most promise among bioactive constituents of the Mediterranean diet for reducing prostate cancer risk, while vitamins C and E have mixed evidence regarding their effectiveness.

Lycopene and resveratrol have been shown to inhibit prostate cancer cell proliferation and development, suggesting that the phytochemicals in the Mediterranean diet may play a protective role against prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioactive compounds of the Mediterranean diet and prostate cancer. López-Guarnido, O., Urquiza-Salvat, N., Saiz, M., et al.[2019]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Mediterranean diet and prostate cancer risk and mortality in the Health Professionals Follow-up Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet and grade group progression in localized prostate cancer: An active surveillance cohort. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Adherence to a low-fat diet in men with prostate cancer. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Dietary Patterns and Risk of Gleason Grade Progression among Men on Active Surveillance for Prostate Cancer: Results from the Canary Prostate Active Surveillance Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet and risk of prostate cancer. [2019]

7. Spain pubmed.ncbi.nlm.nih.gov

Mediterranean diet adherence and prostate cancer risk. [2016]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean Diet, Physical Activity and Survival after Prostate Cancer Diagnosis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Bioactive compounds of the Mediterranean diet and prostate cancer. [2019]