Phase 3 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 confirmed by a tissue biopsy (laboratory analysis of a tissue sample).
• People whose prostate cancer is considered high-risk or locally advanced, meaning at least one of the following applies: a PSA blood test result above 20 ng/mL; cancer that has grown beyond the prostate (stage T3 or T4); a Gleason score (a measure of how aggressive the cancer looks under a microscope) of 8, 9, or 10; or cancer that has spread to nearby lymph nodes (cN1).
• People who are generally well enough to carry out normal daily activities with little or no limitation (ECOG performance status of 0 or 1).
• People who are willing to have a PSMA PET/CT scan (a specialised imaging scan that looks for prostate cancer cells in the body), with or without contrast dye.
• People whose PSMA PET/CT scan shows at least one positive lesion in regional or distant areas outside the pelvis may be placed into either arm of the main (Phase 3) part of the study.
• People whose PSMA PET/CT scan shows no spread beyond the pelvis may still be eligible — either for the main Phase 3 study or a smaller Phase 2 study — depending on the result of a tumour gene test called the Decipher score (confirm with trial site).
• People who are willing to have their tumour tissue tested to determine their Decipher score (a genetic test on the tumour).
• People who are willing to receive standard radiation therapy to the pelvis and long-term hormone therapy (called ADT, which may include a drug called darolutamide).
• People who are able to give written informed consent and are willing and able to attend all study visits and follow all study procedures.
• People who are over 18 years of age.
• People who are able to swallow whole tablets.
• People who are willing to use a condom during sexual activity while on the study drug and for 3 months after the last dose, and who agree not to donate sperm during this period (this applies even to people who have had a vasectomy).
• People whose blood test results show that their bone marrow, kidneys, and liver are functioning adequately, and whose testosterone level is above 50 ng/dL (specific laboratory thresholds apply — confirm with trial site).

Who may not be able to join:

• People whose standard scans (bone scan, CT, or MRI) clearly show the cancer has spread to areas outside the pelvic lymph nodes, such as distant lymph nodes, bones, or other organs.
• People whose prostate cancer is mostly made up of certain uncommon and more aggressive cancer cell types (such as sarcomatoid, neuroendocrine small cell, squamous cell, or other non-glandular types).
• People who have previously had radiation therapy to the pelvic area.
• People who have a medical reason why they cannot safely receive radiation therapy to the pelvis.
• People who have a medical reason why they cannot safely receive hormone therapy (ADT), including darolutamide.
• People who have a known allergy or medical reason that prevents them from having a PSMA PET/CT scan.
• People who have previously had surgery or other local treatments for prostate cancer, such as removal of the prostate (radical prostatectomy), high-intensity focused ultrasound (HIFU), or cryotherapy. Note: people who have had a transurethral resection of the prostate (TURP) or Millin prostatectomy may still be eligible (confirm with trial site).
• People who have previously received systemic (whole-body) drug treatment for prostate cancer — except for people with a positive PSMA PET/CT scan who started hormone therapy (ADT) no more than 4 weeks before being enrolled into the study.
• People who are currently using a medication called a 5-alpha reductase inhibitor, unless it has been stopped at least 2 weeks before joining the study.
• People who are currently using opioid pain medicines on an ongoing basis (for 3 weeks or more if taken by mouth, or 7 days or more if taken another way).
• People who have a history of seizures, or who have a condition that may increase the risk of seizures — including a stroke, mini-stroke (TIA), or loss of consciousness within the past year, certain brain abnormalities, or brain tumours causing swelling or pressure.
• People who, in the treating doctor's opinion, would not benefit from taking part in the trial or for whom participation would not be in their best interest.
• People who have had major surgery within the 21 days before joining the study.
• People who have had any of the following within the 6 months before joining the study: loss of consciousness, a mini-stroke (TIA), or stroke; a serious heart condition such as a heart attack, unstable chest pain, significant heart failure, serious heart rhythm problems, a blood clot (such as deep vein thrombosis or pulmonary embolism), or coronary artery bypass surgery. Note: people with stable atrial fibrillation (an irregular heartbeat) who are on a stable blood-thinning medication may still be eligible (confirm with trial site).
• People who have a bowel (gastrointestinal) condition or have had a bowel procedure that might affect how the body absorbs darolutamide tablets, including difficulty swallowing.
• People who have been diagnosed with another cancer in the past 5 years — with some exceptions for certain low-risk or successfully treated cancers (confirm with trial site, as these cases are reviewed individually).
• People who have a serious ongoing illness or infection that could make it unsafe for them to take part in the study. Note: people living with HIV that is well-controlled with medication that does not interact with darolutamide may still be eligible (confirm with trial site).
• People who are sexually active with women who could become pregnant and who are not willing or able to use highly effective contraception during treatment and for at least 3 months after the last dose of the study drug.

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