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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Secondary study objectives
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
+3 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
74%
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%
Dizziness
15%
Amylase increase
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Erectile dysfunction
6%
Headache
6%
Personality change
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anorexia
3%
Atrial fibrillation
3%
Anxiety
3%
Bruising
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,062 Previous Clinical Trials
1,800,739 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,012,011 Total Patients Enrolled
Justin R GreggPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Radical Prostatectomy Clinical Trial Eligibility Overview. Trial Name: NCT04985565 — N/A
Prostate Adenocarcinoma Research Study Groups: Treatment (dietary intervention, radical prostatectomy)
Prostate Adenocarcinoma Clinical Trial 2023: Radical Prostatectomy Highlights & Side Effects. Trial Name: NCT04985565 — N/A
Radical Prostatectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04985565 — N/A
~3 spots leftby Oct 2025
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