Prostate Cancer Trial, Recruiting NCT05590624 Sponsor: Case Comprehensive Cancer Center Condition: Prostate Cancer
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Prostate Cancer Trial, Recruiting

NCT05590624
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men aged 18 or older
  • Men whose urologist strongly suspects they may have prostate cancer, based on clinical assessment
  • Men with a BMI greater than 18.5
  • Men who have not previously been diagnosed with prostate cancer or received hormonal therapy for it
  • Men who are able to read, write, speak, and understand English
  • Men who are able to give informed consent to participate
  • Men who, if their biopsy comes back positive, are considered suitable for and choose active surveillance (a monitoring approach rather than immediate treatment)
  • Men who are willing to follow the specific dietary plans provided by the study
  • Men whose blood and organ function meet certain health thresholds, including healthy enough levels of white blood cells, platelets, red blood cells, and liver and kidney function (confirm with trial site)

Who may not be able to join:

  • People who are currently following a Mediterranean, low-carbohydrate, ketogenic, vegan, vegetarian, or high-fibre diet, or taking supplements, vitamins, or herbal products that could interfere with the diets being tested in the study
  • People who have previously had difficulty tolerating high-fibre diets
  • People with colitis, irritable bowel syndrome, or other gut conditions, as assessed by their doctor
  • People who are unwilling to have a prostate biopsy performed through the area between the scrotum and the rectum (transperineal biopsy)
  • People with food allergies or significant dietary restrictions
  • People currently receiving medical treatment for Type 1 or Type 2 diabetes
  • People who have taken antibiotics in the 30 days before joining the trial
  • People who have lost 5% or more of their body weight in the last 30 days, whether intentionally or not
  • People who have had any type of weight loss surgery
  • People with any other medical reasons that investigators determine make participation unsafe
  • People considered high risk, defined by a PSA level of 20 or above and/or a specific high-concern finding on prostate imaging (PI-RADS score of 5), as assessed by their doctor
  • People with a history of diabetic ketoacidosis (a serious diabetes complication)
  • People with gout
  • People whose immune system is suppressed, such as those with a history of organ transplant or who are on immunosuppressant medications, as assessed by their doctor
  • People who have had a device or joint implant requiring antibiotic treatment within the last 30 days
  • People with a history of infection following a prostate biopsy
  • People with uncontrolled high blood pressure, defined as a reading above 140/80, with or without medication
  • People who have had their gallbladder removed or are planning to have it removed
  • People currently receiving systemic treatment for another cancer

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Christopher Weight, MD, Center Director, Cleveland Clinic Urologic Oncology

Phone: 216-444-1047

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
3 September 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov