Mediterranean Diet for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Special dietary needs, Unwillingness, Inability to keep appointments, Nuts allergy

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether following a Mediterranean diet can help men with prostate cancer treated at LBJ Hospital in Harris County, TX. The aim is to determine if this dietary change is practical and beneficial for those with recently diagnosed or monitored prostate cancer. The trial specifically targets Black and Hispanic men who have managed their condition for five years or less. Participants should be willing to change their diet and have no allergies to common Mediterranean foods like nuts. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance dietary recommendations for prostate cancer management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dietary changes, so it's best to discuss your medications with the study team.

What prior data suggests that the Mediterranean Diet is safe for men with prostate cancer?

Research has shown that the Mediterranean diet is generally safe and easy to follow. No strong evidence links it to an increased risk of prostate cancer or other serious health issues. In fact, studies suggest that this diet might reduce the risk of prostate cancer progression. For instance, one study found that each point increase in adherence to the Mediterranean diet correlated with a more than 10% lower risk of cancer progression.

This diet emphasizes fruits, vegetables, whole grains, and healthy fats like olive oil. It is associated with various health benefits and is often recommended for its potential to improve overall well-being. Reports of negative effects are insignificant, making it a promising choice for those considering participation in a trial involving a Mediterranean diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Mediterranean Diet for prostate cancer because it offers a holistic approach that differs from traditional treatments like surgery, radiation, or hormone therapy. This diet emphasizes whole foods like fruits, vegetables, whole grains, and healthy fats, which may help reduce cancer progression through anti-inflammatory and antioxidant effects. Unlike conventional treatments that often have significant side effects, the Mediterranean Diet promotes overall health and may improve quality of life while potentially slowing cancer growth.

What evidence suggests that the Mediterranean Diet might be an effective treatment for prostate cancer?

Studies have shown that the Mediterranean diet can lower the risk and slow the progression of prostate cancer. Men who consume more fruits, vegetables, beans, grains, and fish have a reduced chance of their prostate cancer worsening. Research indicates that this diet can decrease cancer deaths by about 24%. Additionally, the Mediterranean diet is linked to improved quality of life and reduced cancer-related fatigue in men. This diet is considered safe and easy to follow, making it a promising option for managing prostate cancer. Participants in this trial will follow the Mediterranean diet to assess its effects on prostate cancer progression and quality of life. ^{2 6 7 8 9}

Who Is on the Research Team?

Justin Gregg, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for medically underserved Hispanic and/or Black/African American men with localized prostate cancer, diagnosed within the last year or currently on active surveillance. Participants must have had a biopsy less than 5 years ago and be patients at LBJ Hospital.

Inclusion Criteria

Self-identified Hispanic and/or Black/African American

Patient at LBJ Hospital

My prostate cancer is confirmed and localized, not spread.

Exclusion Criteria

Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy

I cannot commit to attending all scheduled appointments.

I am not willing to change my diet for medical reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow a Mediterranean diet intervention adapted for underrepresented minority men with prostate cancer

6 months

Regular sessions and clinic visits

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

6 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet

Trial Overview The study is testing the feasibility of a Mediterranean diet intervention among men with prostate cancer treated at LBJ Hospital. It builds upon previous research to see if this diet can benefit those in a safety net healthcare setting.

How Is the Trial Designed?

Group I: Intervention with Mediterranean Diet Experimental Treatment 1 Intervention

Twenty-five (25) self-identified Black and/or Hispanic men with newly diagnosed (within 6 months) localized PCa or who have been managed on active surveillance for less than 5 years will be enrolled along with their spouses (if applicable).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

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

The Mediterranean Diet Reduces the Risk and Mortality ... - PMC 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. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/3495/702544/Abstract-3495-A-novel-Mediterranean-dietary

A novel Mediterranean dietary intervention for prostate cancer The Mediterranean diet (MD) specifically may be beneficial for men with localized prostate cancer (PCa) on active surveillance (AS) because of its anti- ...

4. europeanurology.com europeanurology.com/article/S0302-2838(25)00433-6/fulltext

Dietary Patterns in Prostate Cancer Prevention and ... Among patients with PC, Mediterranean, plant-based, and low-inflammatory diets were more consistently linked to lower risk of progression and PC ...

5. 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.

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/abs/pii/S1047279718302837

Dietary patterns based on the Mediterranean diet and ... Conclusions. Higher diet quality, as represented by a Mediterranean-style diet or DASH diet, may reduce the odds of high aggressive prostate 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. journals.lww.com journals.lww.com/md-journal/fulltext/2019/07050/mediterranean_dietary_pattern_and_the_risk_of.103.aspx

Mediterranean dietary pattern and the risk of prostate cancer Our meta-analysis of 10 eligible epidemiological studies provides evidence that Mediterranean Diet is not related with the risk of total, advanced, localized, ...