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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies the effects of a dietary intervention prior to surgery (neoadjuvant) in patients with intermediate risk prostate cancer. Changing your diet before surgery may help to improve overall health. Information from this study may help researchers better understand the influence of diet on the outcomes of patients with intermediate prostate cancer.

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.

What data supports the effectiveness of the treatment Dietary Intervention, Nutritional Counseling, Dietary Therapy, Radical Prostatectomy, Robot-Assisted Radical Prostatectomy, RARP, Laparoscopic Prostatectomy, Open Prostatectomy for prostate cancer?

Research shows that robot-assisted radical prostatectomy (RARP) often results in less blood loss and better recovery of urinary and sexual functions compared to open surgery. This suggests that RARP might be a more effective surgical option for treating prostate cancer. ^{1 2 3 4 5}

Is the dietary intervention for prostate cancer safe for humans?

The safety of robot-assisted radical prostatectomy (RARP), a surgical procedure for prostate cancer, has been evaluated in several studies. These studies suggest that RARP is generally safe, with similar outcomes to open surgery, and efforts are being made to reduce the risk of complications. ^{6 7 8 9 10}

How is Radical Prostatectomy different from other treatments for prostate cancer?

Radical Prostatectomy is a surgical treatment that involves the removal of the prostate gland and some surrounding tissue, which is different from other treatments like radiation or hormone therapy that do not involve surgery. This procedure can be performed using different techniques, such as robot-assisted, laparoscopic, or open surgery, offering various options based on the patient's condition and surgeon's expertise. ^{11 12 13 14 15}

Research Team

Justin Gregg, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Laparoscopic and robot-assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic review. [2019]

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

Robot-assisted radical prostatectomy vs. open radical prostatectomy: latest evidences on perioperative, functional and oncological outcomes. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Robotic-assisted radical prostatectomy]. [2018]

4. England 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. [2023]

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

Open Versus Robotic Radical Prostatectomy in Obese Men. [2020]

6. India pubmed.ncbi.nlm.nih.gov

Perioperative adverse events and functional outcomes following open and robot-assisted prostatectomy in patients over age 70. [2021]

7. Canada 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. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: a 2010 update. [2011]

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

How does robot-assisted radical prostatectomy (RARP) compare with open surgery in men with high-risk prostate cancer? [2013]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Reducing the Risk of Postoperative Complications After Robot-assisted Radical Prostatectomy in Prostate Cancer Patients: Results of an Audit and Feedback Intervention Following the Implementation of Prospective Data Collection. [2022]

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

Dietary intervention strategies to modulate prostate cancer risk and prognosis. [2009]

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

Diet and survival after prostate cancer diagnosis. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Dietary modification in patients with prostate cancer on active surveillance: a randomized, multicentre feasibility study. [2015]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Men with prostate cancer make positive dietary changes following diagnosis and treatment. [2021]

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

The evolving role of diet in prostate cancer risk and progression. [2023]