Clinical trial for Prostate Cancer
Official title Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
ClinicalTrials.gov ID: NCT06487507
What this study is testing
- What it's testing
- The study wants to find out if eating a controlled Mediterranean diet before robotic-assisted radical prostatectomy changes fasting insulin and other blood and tissue measurements.
- Who it's for
- Men who have been diagnosed with prostate cancer and are scheduled for robotic-assisted radical prostatectomy.
- What's involved
- Participants will follow a Mediterranean-style diet for a set period before their surgery and will have blood drawn and tissue samples taken at the time of surgery.
- Time commitment
- Participants follow the diet until surgery and attend study visits for diet counseling and sample collection at the surgery appointment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
- BMI between 18.5 and 40
- Ability to read, write, speak, and understand English and/or Spanish.
- Ability to provide informed consent.
- Willingness to consume provided dietary interventions.
You likely can't join if
- Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber \> per 1,000 Calories) and/or any...
- Previous intolerability to fiber-rich diets.
- Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
- Food allergies or other major dietary restrictions.
- Receiving active medical treatment for Type I or Type II diabetes mellitus.
- Recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days.
See the full eligibility criteria
- Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
- BMI between 18.5 and 40
- Ability to read, write, speak, and understand English and/or Spanish.
- Ability to provide informed consent.
- Willingness to consume provided dietary interventions.
- Adequate organ and marrow function as assessed by treating clinician(s) which includes: White blood cell count (WBC) ≥2,500/microliter. Absolute neutrophil count (ANC) ≥1,500/microliter. Platelets ≥100,000/microliter.
- Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber \> per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would...
- Previous intolerability to fiber-rich diets.
- Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
- Food allergies or other major dietary restrictions.
- Receiving active medical treatment for Type I or Type II diabetes mellitus.
- Recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days.
- Undergone any type of weight loss surgery.
- Any medical contraindications as determined by investigators.
- History of diabetic ketoacidosis.
- History of Gout.
- Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion.
- Gallbladder removed or plan to remove per clinician evaluation.
- Other malignancies actively receiving systemic treatment as per clinician evaluation.
- Previous treatment for prostate cancer.
- Previous history of pelvic radiation.
- Patients with impaired decision-making capacity.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.