Dietary Intervention for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Dietary restrictions, Smoking, Heavy drinking, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a Mediterranean diet, followed before surgery, might improve health outcomes for men with intermediate-risk prostate cancer. Participants will follow this diet for four weeks leading up to their radical prostatectomy. Men diagnosed with intermediate-risk prostate cancer, with a BMI of 26 to 39, and willing to follow the diet might be suitable candidates. Researchers aim to understand the impact of dietary changes on cancer treatment results. As an unphased trial, this study offers a unique opportunity to contribute to understanding how dietary changes might enhance cancer treatment outcomes.

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's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that dietary changes can be safe and might help with prostate cancer. One study found that a low-fat diet could slow the growth of prostate cancer cells. Another review suggested that plant-based diets might reduce the risk of prostate cancer progression.

Overall, patients usually find these dietary changes manageable. They involve everyday foods, making serious side effects less likely. While dietary changes aren't a guaranteed solution, they appear to be a safe option to try alongside other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dietary intervention for prostate cancer because it incorporates the Mediterranean diet before undergoing a radical prostatectomy. Unlike standard prostate cancer treatments, which typically focus solely on surgical or pharmaceutical interventions, this approach integrates nutrition to potentially enhance the body's response to surgery. The Mediterranean diet is rich in fruits, vegetables, whole grains, and healthy fats, which may help reduce inflammation and improve overall health. By combining this diet with the surgical procedure, there is hope for improved outcomes and a novel way to support the body's natural defenses against cancer.

What evidence suggests that this trial's dietary intervention and radical prostatectomy could be effective for prostate cancer?

Studies have shown that dietary changes can affect prostate cancer. For instance, reducing fat intake might slow the growth of prostate cancer cells. Additionally, following a diet like the Mediterranean diet benefits heart health, which is crucial for cancer patients' overall well-being. Some research has indicated that dietary changes can impact health factors related to prostate cancer. Although not all studies agree, these findings suggest that diet might help manage prostate cancer. Participants in this trial will follow the Mediterranean diet for six days per week for four weeks before undergoing standard-of-care radical prostatectomy. ^{1 3 4 6 7}

Who Is on the Research Team?

Justin Gregg, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Men aged 30-75 with intermediate risk prostate cancer, willing to change their diet before surgery. They must have a waist size >=40 inches, Gleason Grade 2 or 3, PSA <=20 ng/mL, and be considered for radical prostatectomy. Excludes high-risk cancers, dietary restrictions/allergies, smokers/heavy drinkers/drug users.

Inclusion Criteria

Willingness to comply with all study procedures and scheduled visits

Waist circumference >= 40 inches

Gleason Grade group 2 or 3 on biopsy

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Equilibration

Participants enter a pre-intervention equilibration period to prepare for the dietary intervention

1-2 weeks

Dietary Intervention

Participants follow a Mediterranean diet for 6 days per week for 4 weeks before surgery

4 weeks

Weekly check-ins (virtual or in-person)

Surgery

Participants undergo standard of care radical prostatectomy

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

4-8 weeks

2-3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention
• Radical Prostatectomy

Trial Overview The trial is testing the impact of a special diet on men's health before they undergo surgery for intermediate risk prostate cancer. It aims to understand how changing one's diet can affect surgical outcomes in these patients.

How Is the Trial Designed?

Group I: Treatment (dietary intervention, radical prostatectomy) Experimental Treatment 2 Interventions

Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.

Radical Prostatectomy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Radical Prostatectomy for:

• Prostate cancer

Approved in United States as Radical Prostatectomy for:

• Prostate cancer

Approved in Canada as Radical Prostatectomy for:

• Prostate cancer

Approved in Japan as Radical Prostatectomy for:

• Prostate cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A diet-based intervention using telephone counselling significantly increased vegetable intake and plasma levels of beneficial carotenoids in 43 men with prostate cancer on active surveillance over 6 months.

The intervention led to substantial increases in the consumption of cruciferous vegetables and tomato products, suggesting a potential dietary approach to inhibit prostate cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary modification in patients with prostate cancer on active surveillance: a randomized, multicentre feasibility study. Parsons, JK., Newman, VA., Mohler, JL., et al.[2015]

Robot-assisted laparoscopic radical prostatectomy (RALP) offers better functional outcomes, such as improved continence and potency rates, and reduces blood loss compared to open radical prostatectomy (ORP).

While RALP shows a lower incidence of positive surgical margins, its effectiveness in treating nonorgan-confined prostate cancer remains unclear, and long-term oncologic outcomes are comparable to those of ORP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Robotic-assisted radical prostatectomy]. Thomas, C., Neisius, A., Roos, FC., et al.[2018]

Recent studies indicate that very low-fat vegan diets and low-glycemic index diets can positively influence tumor biology in prostate cancer patients, potentially through mechanisms like weight loss.

Preclinical data suggest that both very low-fat and low-carbohydrate diets can slow tumor growth in mice, highlighting the need for larger clinical trials to confirm these effects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intervention strategies to modulate prostate cancer risk and prognosis. Freedland, SJ., Aronson, WJ.[2009]

In a study of 251 elderly men (≥70 years old) who underwent either open retropubic radical prostatectomy (ORRP) or robot-assisted radical prostatectomy (RARP), the rates of major complications were similar for both surgical methods, at 4.7% for ORRP and 4.9% for RARP.

Both surgical approaches resulted in comparable continence rates after 24 months (78.5% for ORRP vs. 79.4% for RARP), but the rates of erectile function remained low, indicating that while safety is similar, functional outcomes may still be a concern for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative adverse events and functional outcomes following open and robot-assisted prostatectomy in patients over age 70. Sancı, A., Özkaya, MF., Oguz, ES., et al.[2021]

A study of 66,683 patients who underwent robotic-assisted radical prostatectomy (RARP) from 2011 to 2019 showed that the procedure is increasingly being performed on older and frailer patients without an increase in postoperative morbidity or mortality.

Despite the rising frailty in the patient population, the operative time and length of hospital stay for RARP have decreased, indicating improved efficiency of the procedure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted radical prostatectomy is pushing the boundaries: a national survey of frailty using the national surgical quality improvement program. Abou Heidar, NF., Ayoub, CH., Abou Mrad, A., et al.[2023]

A review of 25 studies, including 8 observational and 17 intervention trials, suggests that plant-based diets may positively influence the progression and clinical outcomes of prostate cancer.

While more long-term clinical trials are necessary, early findings indicate that encouraging patients to adopt plant-based diets could be a valuable part of their treatment plan for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and survival after prostate cancer diagnosis. Berkow, SE., Barnard, ND., Saxe, GA., et al.[2019]

In a study of 317 patients undergoing robotic radical prostatectomy (RARP) at a medium-volume center, 30.3% experienced complications, mostly minor (84.4% classified as Clavien grade 1 and 2), indicating a generally high safety profile for the procedure.

The nerve-sparing surgical technique was identified as an independent predictor of complications, suggesting that while it may be beneficial for preserving function, it could also increase the risk of postoperative issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence between hospital volume and perioperative outcome: Prospective assessment of robotic radical prostatectomy safety profile in a regional center of medium annual caseload. Ferrari, M., Mazzola, B., Roggero, E., et al.[2021]

Robotic-assisted laparoscopic prostatectomy (RALP) demonstrated high safety with no conversions to open surgery or re-operations in the first 100 cases studied, with an average blood loss of only 281 ml and a short hospital stay of 1.1 nights.

Efficacy results showed an 18% positive margin rate overall, with only 8% for pT2 tumors, and 68% of patients reported no incontinence at 12 months, indicating RALP is effective in managing prostate cancer with favorable postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: a 2010 update. Duthie, JB., Pickford, JE., Gilling, PJ.[2011]

A study comparing 177 patients who underwent open retropubic radical prostatectomy (RRP) and 233 patients who had robot-assisted radical prostatectomy (RARP) found no significant differences in cancer recurrence rates or positive margin rates, indicating that RARP is a safe and effective option for high-risk prostate cancer patients.

Patients who underwent RARP experienced less blood loss and were more likely to have complete bilateral nerve-sparing procedures compared to those who had open RRP, suggesting additional benefits of the robotic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does robot-assisted radical prostatectomy (RARP) compare with open surgery in men with high-risk prostate cancer? Punnen, S., Meng, MV., Cooperberg, MR., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4286914/

Nutrition, dietary interventions and prostate cancer Growth inhibitory effect of low fat diet on prostate cancer cells: results of a prospective, randomized dietary intervention trial in men with prostate cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000355

Review article The effect of dietary interventions or patterns ... This review synthesizes the evidence on the effect of dietary interventions on cardiometabolic biomarkers and cardiovascular disease risk in prostate cancer ...

3. academic.oup.com academic.oup.com/jnci/article/116/7/1026/7617726

Dietary interventions in cancer: a systematic review of all ... In this systematic review, we assessed all randomized controlled trials (RCTs) investigating dietary interventions for cancer patients.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38973750/

a target trial emulation in the Health Professionals Follow-up ... We emulated a target trial of recommendation-based physical activity and dietary strategies and 26-year risks of prostate cancer, adjusting for risk factors ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2758598

Effect of a Behavioral Intervention to Increase Vegetable ... A behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression among men with early-stage ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283825004336

Dietary Patterns in Prostate Cancer Prevention and ... Our review suggests that plant-based and healthy dietary patterns are associated with lower PC risks that are more obvious for progression than ...

7. mdpi.com mdpi.com/2072-6643/17/13/2151

Nutrition and Diet in the Prevention and Management of ... This study aims to analyze global scientific evidence regarding the role of diet in the prevention and management of prostate cancer.