Study Summary
This trial looks at the benefits of changing your diet before surgery for intermediate risk prostate cancer patients.
Eligible Conditions
- Prostate Adenocarcinoma
- Stage IIB Prostate Cancer
- Stage II Prostate Cancer
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIIA Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 1 year
Up to 1 year
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
Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer percentage of severe adverse reactions in patients completing the diet.
The effects of controlled dietary interventions on metabolic parameters
The effects of controlled dietary interventions on the fecal microbiome
Tolerance of Mediterranean diet
Year 1
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Trial Safety
Safety Progress
Side Effects for
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
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%Cholesterol high
18%ACTH increase
15%Dizziness
15%Amylase increase
12%Constipation
12%White blood cell decrease
12%Lymphocyte count decrease
12%Memory impairment
9%Arthralgia
9%LDH increase
9%Myalgia
9%Paresthesia
9%Weight loss
9%Hypothyrodism
6%Dyspnea
6%Hypertriglyceridemia
6%Insomnia
6%Personality change
6%Irritability
6%Headache
6%Dysgeusia
6%HbA1c increased
6%Erectile dysfunction
3%Anxiety
3%Bruising
3%Anorexia
3%TSH increased
3%Atrial fibrillation
3%Hypercalcemia
3%Dehydration
Trial Design
1 Treatment Group
Treatment (dietary intervention, radical prostatectomy)
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Radical Prostatectomy · No Placebo Group · N/A
Treatment (dietary intervention, radical prostatectomy)Experimental Group · 2 Interventions: Dietary Intervention, Radical Prostatectomy · Intervention Types: Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4520
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,361 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,086 Previous Clinical Trials
41,141,636 Total Patients Enrolled
Justin R GreggPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 30 - 75 · Male Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Prostate specific antigen (PSA) < 20 ng/mL.
You are a surgical candidate for radical prostatectomy.
You are 40 or more inches in waist circumference.
You are willing to eat all the provided meals.
You are willing to travel to MD Anderson for study-related visits.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments