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Radical Prostatectomy for Prostate Adenocarcinoma

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/prostate">prostate</a>. 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

Q: 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.

Q: 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.

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

Study 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

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

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%

Amylase increase

15%

Dizziness

12%

Memory impairment

12%

White blood cell decrease

12%

Constipation

12%

Lymphocyte count decrease

Paresthesia

Myalgia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Personality change

Erectile dysfunction

Headache

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anxiety

Atrial fibrillation

Bruising

Anorexia

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,496 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,359 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

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

2021. "Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04985565.

All > Prostate Cancer Houston