Early Phase 1 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with prostate cancer through a tissue biopsy, where the cancer is contained within the prostate (no spread to other areas), and the cancer falls into an intermediate-risk category based on specific test results (confirm with trial site for full details)
• People whose prostate cancer staging is classified as T2c or lower based on imaging
• People whose biopsy results show a Gleason Grade Group of 2 or 3
• People whose PSA (a prostate-related blood test) level is 20 ng/mL or below
• People who have chosen surgery (open or robotic) to treat their prostate cancer, and whose surgeon has determined they are a suitable candidate for that surgery
• Adult men between the ages of 31 and 74
• People who have been diagnosed with diabetes AND also meet at least one of the following body weight criteria:
  • A Body Mass Index (BMI) of 27 or higher AND a waist measurement greater than 40 inches
  • A BMI of 30 or higher (regardless of other conditions)
  • A BMI of 27 or higher AND at least one weight-related health condition, such as high blood pressure, abnormal cholesterol or triglyceride levels, obstructive sleep apnea, or certain heart conditions (confirm specific values with trial site)

Who may not be able to join:

• People whose prostate cancer is classified as high or very high risk, including those with Grade Group 4 or 5 cancer, or disease staging of pT3a or higher
• People whose imaging shows the cancer has spread to other parts of the body
• People who have lost more than 5 kg (about 11 pounds) of body weight — whether intentionally or not — in the 90 days before screening
• People who have previously received hormone therapy, chemotherapy, surgery, or radiation treatment for prostate cancer
• People who have previously had weight-loss surgery, are planning to have it, or have used weight-loss medication in the 90 days before screening
• People with significantly reduced kidney function (as measured by a specific blood test called eGFR below 30)
• People with a known significant problem with stomach emptying (such as severe diabetic gastroparesis) or who regularly take medications that affect how the digestive system moves food through
• People with a history of pancreatitis (inflammation of the pancreas), either sudden or long-term
• People who have had significant or unstable major depression, schizophrenia, bipolar disorder, or other serious mood or anxiety disorders within the last 2 years (people with stable, well-managed depression or anxiety may still be considered — confirm with trial site)
• People who have experienced a heart attack, stroke, unstable chest pain, or hospitalisation for heart failure in the 3 months before enrolling
• People with the most severe level of heart failure (classified as NYHA Class IV)
• People with active or chronic hepatitis, certain other liver diseases, or specific abnormal liver blood test results above set thresholds (confirm with trial site; people with fatty liver disease may still be eligible if liver enzyme levels are within acceptable range)
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related genetic condition called Multiple Endocrine Neoplasia type 2
• People who have had another cancer diagnosis (other than certain skin cancers) and have not been in remission for at least 5 years
• People who have a known allergy or intolerance to a class of medications called GLP-1 receptor agonists (confirm with trial site)
• People with a history of drug or alcohol misuse, an eating disorder, or another condition that the trial doctor believes may prevent them from safely completing the trial
• People who have used marijuana in the 3 months before enrolling, or who are unwilling to stop using marijuana or cannabidiol (CBD) oil for the duration of the trial
• People who have received an organ transplant (corneal/eye transplants are allowed) or who are currently waiting for an organ transplant

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