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Radical Prostatectomy for Prostate Adenocarcinoma

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
Meet one of the following criteria for overweight or obesity:
Body Mass Index (BMI) between 26 and 39
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial looks at the benefits of changing your diet before surgery for intermediate risk prostate cancer patients.

Eligible Conditions
  • Prostate Adenocarcinoma
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are either overweight or obese based on certain measurements of your body.
Select...
Your body mass index (BMI) falls between 26 and 39.

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

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 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
91%
Hot flashes
88%
Fatigue
62%
Anemia
47%
Hyperglycemia
41%
Dry skin
32%
Cholesterol high
29%
Rash
29%
Insomnia
26%
Dizziness
26%
TSH increased
26%
Hypertriglyceridemia
24%
Arthralgia
24%
Headache
21%
Lipase increase
21%
Memory impairment
15%
Hypertension
12%
AST increase
12%
Amylase increase
12%
White blood cell decrease
12%
Anxiety
12%
Dysgeusia
12%
Irritability
12%
Nausea
9%
ALT increase
9%
Alopecia
9%
Erectile dysfunction
9%
Hypothyrodism
6%
Paresthesia
6%
Bruising
6%
Weight loss
6%
Anorexia
6%
Cognitive disturbance
6%
Constipation
6%
HbA1c increased
6%
GERD
6%
Generalized Muscle Weakness
6%
Hypercalcemia
6%
Fall
6%
Lymphocyte count decrease
6%
Insulin increase
6%
LDH increase
6%
Vitamin D decrease
3%
Personality change
3%
Myalgia
3%
Syncope
3%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (LHRHa, Apalutamide)
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

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
2,943 Previous Clinical Trials
1,775,318 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,576 Previous Clinical Trials
41,224,177 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for participants in this experiment?

"Affirmative, information hosted on clinicaltrials.gov confirms that this medical study, which was initially advertised on August 27th 2021 is currently recruiting. 10 individuals need to be enlisted from a single research site."

Answered by AI

Am I eligible to engage in this scientific research?

"This clinical trial seeks 10 adult males aged between 30 and 75 with a malignant neoplasm of the prostate. Candidates must meet additional criteria, including: Prostate specific antigen (PSA) levels at less than 20 ng/mL, eligibility for radical prostatectomy, disease not exceeding T2b-T2c on the Clinical scale or lower Gleason Grade group 2 or 3 on biopsy; BMI in the range 26 to 39; waist circumference of 40 inches or more; exclusive use of provided meals throughout study duration; reside within Houston area and its environs OR be willing to travel for study visits at MD Anderson"

Answered by AI

What is the maximum capacity of participants for this experiment?

"Affirmative, the listing on clinicaltrials.gov reveals that this research trial is looking for participants at present. The study was first posted in August 27th 2021, with its most recent update being on September 26th 2022. This investigation requires 10 people from a single medical site."

Answered by AI

Is the eligibility criteria for this trial limited to participants over twenty years of age?

"To be eligible to participate in this trial, applicants must be aged between 30 and 75 years. For younger patients, there are 72 trials available while 1,270 studies cater for those above the age of 65."

Answered by AI
~3 spots leftby Feb 2025