Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 are 18 years of age or older.
• People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer confirmed by a biopsy taken within the past 12 months) and have that tissue sample available if needed for future testing.
• People whose cancer is considered high-risk, meaning it meets at least one of the following: a high Gleason grade group score (grade group 4 or higher, indicating more aggressive cancer cells); cancer that has spread to nearby pelvic lymph nodes as seen on imaging; or a tumour that has grown outside the prostate into nearby tissues such as the bladder or pelvic wall.
• People who have no signs of cancer that has spread to distant parts of the body, as confirmed by specialised imaging scans (small lymph node involvement near the prostate area is still permitted).
• People who are planning to have surgery to remove the prostate (called a radical prostatectomy), with or without removal of nearby lymph nodes, and whose surgeon considers the surgery possible.
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (ECOG scale), meaning they are able to carry out daily activities, possibly with some limitations.
• People whose blood tests show that their bone marrow, liver, and kidneys are functioning adequately (specific normal ranges will be checked by the trial team).
• People who are willing and able to read and sign a consent form agreeing to take part.
• People living with HIV who are on effective treatment and have had an undetectable level of the virus in their blood within the past 6 months.
• People with a history of chronic hepatitis B who are on appropriate treatment and have an undetectable level of the virus in their blood.
• People who previously had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C with an undetectable viral level.
• People who have or have had another type of cancer, as long as that cancer or its treatment is unlikely to interfere with this trial's results or safety assessments (confirm with trial site).
• People who agree to use adequate contraception during the study and for 8 weeks after the last dose of study treatment, as one of the study drugs may be harmful to a developing foetus.

Who may not be able to join:

• People who are unable or unwilling to have MRI scans, or who have medical devices that are not safe in MRI machines, such as certain heart pacemakers or certain metal implants in the brain.
• People who cannot have a device called an endorectal coil placed during the MRI scan — for example, those who have had certain bowel surgeries or have a latex allergy (though the trial's lead doctor may waive this requirement in some cases).
• People who cannot receive gadolinium contrast dye used during MRI scans — for example, those with a known allergy to it or with poor kidney function.
• People who have a metal hip replacement or other metallic implant or device that would interfere with MRI scan quality.
• People with poorly controlled high blood pressure, specifically a reading above 160/100 mmHg at the time of joining the trial.
• People with moderate to severe heart failure (rated at level 2 or above on a standard heart failure scale).
• People with a significant history of abnormal heart electrical activity, a family history of a condition called long QT syndrome, or who have had a heart attack within the past 6 months.
• People who have previously received any treatment for prostate cancer (note: certain prostate-related medications called 5-alpha reductase inhibitors, such as finasteride or dutasteride, are allowed if stopped at least 3 weeks before the first dose).
• People who are currently taking part in another clinical trial or who received an experimental treatment or used an experimental medical device within 2 weeks before the first dose.
• People who are currently taking certain medications that strongly affect how the body processes a class of drugs (known as strong CYP3A4 inhibitors or inducers — examples include ketoconazole, rifampin, carbamazepine, and clarithromycin; confirm the full list with the trial site).

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