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Dietary Intervention for Prostate Cancer
N/A
Waitlist Available
Led By Justin R Gregg
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Summary
This trial looks at the benefits of changing your diet before surgery for intermediate risk prostate cancer patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not drug-related, potential side effects may include changes in digestion due to new dietary habits and possible nutritional deficiencies if the diet does not meet all of the patient's needs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Secondary outcome measures
Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis
Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption
Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention
+4 moreSide effects data
From 2021 Phase 2 trial • 86 Patients • NCT0327925074%
Hot flashes
71%
Fatigue
44%
Anemia
38%
Hyperglycemia
26%
AST increase
26%
Hypertension
26%
Lipase increase
24%
ALT increase
24%
Dry skin
21%
Rash
18%
ACTH increase
18%
Cholesterol high
15%
Amylase increase
15%
Dizziness
12%
White blood cell decrease
12%
Memory impairment
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Personality change
6%
Headache
6%
Erectile dysfunction
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Bruising
3%
Anxiety
3%
Atrial fibrillation
3%
Anorexia
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dietary intervention, radical prostatectomy)Experimental Treatment2 Interventions
Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4550
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,267 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,389 Total Patients Enrolled
Justin R GreggPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have major restrictions in your diet or severe food allergies.You are either overweight or obese based on certain measurements of your body.You smoke, drink heavily (more than 14 drinks per week), or use illegal drugs.Your body mass index (BMI) falls between 26 and 39.You don't like or can't eat foods that are part of the Mediterranean diet such as vegetables, grains, animal products or fish.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dietary intervention, radical prostatectomy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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