Phase 2 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:

• You must have been confirmed through a biopsy to have a type of prostate cancer called prostate adenocarcinoma
• Your cancer must be a Grade Group of 1, 2, or 3 (meaning low to intermediate risk, not the highest grade)
• Your PSA level (a prostate cancer blood test) must have been below 20 ng/mL before starting any hormone therapy, if that was used
• Your cancer must be at an early to moderate stage based on a physical exam (no spread beyond certain limits)
• You must have had an MRI scan of the prostate within the last 12 months, showing the tumour in a specific way (confirm with trial site)
• The tumour visible on MRI must score 3, 4, or 5 on a standard rating system used by radiologists (PIRADS v2.1)
• The tumour seen on MRI must be 2.5 cm or smaller at its widest point and be treatable with a radiation boost without harming surrounding structures
• The area of cancer seen on MRI must have been confirmed as cancerous by biopsy
• You may be receiving certain types of hormone therapy (ADT) if that is standard care for you, but no more than 6 months of it is allowed
• Your prostate gland must be 90 mL or smaller in size
• There must be no sign that the cancer has spread to lymph nodes or other parts of the body
• You must be 18 years of age or older
• You must be well enough to carry out daily activities, with only mild limitations at most (this is measured using a standard scale called ECOG, score of 0, 1, or 2)
• Your blood counts must be at acceptable levels — including white blood cells, platelets, and haemoglobin (confirm specific numbers with trial site)
• Your kidneys must be functioning well enough, based on a calculation using your age, weight, and a blood test result
• Your liver must be functioning within acceptable limits based on standard blood tests
• Your heart must be functioning at a level of "Class 2B or better" on a standard heart health scale (confirm with trial site)
• You must be willing and able to sign a consent form showing you understand the trial
• You must be willing to use contraception during treatment and for 1 year afterwards, if this applies to you
• You must be willing and able to complete health and wellbeing questionnaires throughout the study

Who may not be able to join:

• You have previously had radiation treatment to the prostate, prostate surgery (including a procedure called TURP), or any other local treatment for prostate cancer
• You have high-grade cancer (Grade Group 3) in an area of the prostate that cannot be seen on MRI
• You have any reason you cannot have an MRI scan, such as a pacemaker, certain metal implants in your body, or severe claustrophobia (fear of enclosed spaces)
• There is evidence that your cancer has spread to lymph nodes or other parts of the body
• You have an active infection that requires antibiotics given through a drip or injection
• You have a urinary symptom score (called IPSS) greater than 19, meaning very severe urinary problems
• You have severe urinary symptoms that your doctor feels would make this type of radiation treatment (called extreme hypofractionation) unsuitable for you
• You have other health conditions that could cause serious side effects from the treatment or stop you from being followed up over the long term (for example, a condition called inflammatory bowel disease)
• You need more than 6 months of hormone therapy (ADT) based on your cancer characteristics
• You have a heart condition classified as worse than "Class 2B" on a standard heart health scale (confirm with trial site)

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