Radical Prostatectomy for Prostate Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Adenocarcinoma+6 MoreRadical Prostatectomy - Procedure
Eligibility
30 - 75
Male
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03279250) in the Arm B (LHRHa, Apalutamide, Abiraterone Acetate) ARM group. Side effects include: Hot flashes with 74%, Fatigue with 71%, Anemia with 44%, Hyperglycemia with 38%, AST increase with 26%.

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.