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?

This trial explores how different Mediterranean-style diets affect the metabolism of men who might have localized prostate cancer. Participants will follow either a low-fat Mediterranean diet (Low-Fat Med-t-Diet) or a lower-carbohydrate version (Lower-Carbohydrate Med-t-Diet). This helps researchers understand potential dietary benefits for managing prostate cancer. Men with a high suspicion of prostate cancer, based on a doctor's evaluation, and who are open to dietary changes, might be a good fit for this study. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on diet and prostate cancer management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the Lower-Carbohydrate and Low-Fat Mediterranean diets are generally safe and linked to health benefits.

For the Lower-Carbohydrate Mediterranean Diet, past studies have not found major safety issues. One study on mice using similar diets did not show significant differences in tumor growth or survival, suggesting the diet might be well-tolerated. While these results are encouraging, more research on humans is needed to confirm safety.

The Low-Fat Mediterranean Diet is also considered safe. Studies indicate that eating lots of fruits, vegetables, beans, grains, and fish can lower the risk of prostate cancer progression. This suggests the diet is not only safe but may also be beneficial. However, some studies have mixed results about its effect on prostate cancer risk, so more research might be needed.

Both diets are based on the Mediterranean diet, known for promoting overall health. There's no strong evidence of harmful effects, but people may react differently. Always consult a healthcare provider before making significant dietary changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, the Mediterranean Diets under investigation focus on dietary changes to manage the condition. Researchers are excited about these dietary interventions because they explore how specific nutritional patterns can influence prostate cancer progression, potentially offering a non-invasive and side-effect-free approach. The Lower-Carbohydrate and Low-Fat Mediterranean diets are being tested for their ability to support active surveillance strategies, which could lead to more personalized and less aggressive management options for patients.

What evidence suggests that this trial's Mediterranean-type diets could be effective for prostate cancer?

Research has shown that the Mediterranean diet, whether in a lower-carbohydrate or low-fat form, may benefit prostate cancer patients. In this trial, participants will be randomized to receive either the Lower-Carbohydrate Mediterranean Diet or the Low-Fat Mediterranean Diet first. Studies suggest that the lower-carbohydrate version might help control tumor growth and improve overall health. Specifically, one trial found that men with prostate cancer experienced positive health changes with this diet. Regarding the low-fat Mediterranean diet, evidence suggests it may reduce the risk of cancer growth and spread. Men on this diet saw a decrease in the advancement of prostate cancer. Overall, both diets are linked to a lower risk of cancer progression, making them promising options for managing prostate cancer. ^{2 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

Ability to read, write, speak, and understand English

I am a man aged 18 or older.

Exclusion Criteria

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

I have gout.

I am currently being treated for diabetes.

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 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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5573712/

The Mediterranean Diet Reduces the Risk and Mortality of the ... Specifically, a two-point increment in the Mediterranean-diet score corresponded to 24% reduction in mortality for cancer (HR 0.76; 95% CI 0.59– ...

2. mdanderson.org mdanderson.org/newsroom/mediterranean-diet-may-decrease-risk-of-prostate-cancer-progression-for-men-on-active-surveillance.h00-159457689.html

Mediterranean diet may decrease risk of prostate cancer ... Men with a diet that contained more fruits, vegetables, legumes, cereals and fish had a reduced risk of their prostate cancer growing or advancing.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5768457/

Mediterranean Diet After Prostate Cancer Diagnosis and ... No statistically significant relationships were observed between the Mediterranean Diet Score after prostate cancer diagnosis and urinary or sexual function.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561420302508

Mediterranean-style dietary pattern improves cancer ... The MED-diet is safe and feasible, and has the potential to improve CRF and quality of life in overweight men treated with ADT compared to usual care.

5. mdanderson.org mdanderson.org/cancerwise/mediterranean-diet-may-slow-prostate-cancer-progression.h00-159457689.html

Mediterranean diet may slow prostate cancer progression Every one point increase in diet score was associated with a more than 10% drop in risk for prostate tumor progression. Here's what to know ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4157361/

Mediterranean Diet and Prostate Cancer Risk and Mortality ... Our results suggest no statistically significant association between the Med-Diet prior to diagnosis and incidence of advanced, lethal, or fatal ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0378512223004474

Mediterranean diet for cancer prevention and survivorship Current data show that the Mediterranean diet is inversely associated with risk, or is risk neutral, for most types of cancer.

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33182

Adherence to the Mediterranean diet and grade group ... The MD is associated with a lower risk of GG progression in men on AS, and this is consistent with prior reports about the MD and reduced cancer ...

9. urologytimes.com urologytimes.com/view/systematic-review-highlights-diet-s-role-in-prostate-cancer-outcomes

Systematic review highlights diet's role in prostate cancer ... Surprisingly, the Mediterranean diet—which has shown benefits in other areas of health—was not consistently linked to prostate cancer risk ...