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 signed a written consent form before any trial procedures begin (a trusted representative, who is not the investigator or sponsor, may sign on behalf of someone who is physically unable to do so)
• Men aged 18 to 80 years
• People who are fully active or have only minor restrictions in physical activity, as measured by a standard medical scale (ECOG score of 0 or 1)
• People without serious other health conditions that might prevent long-term follow-up
• People who have been confirmed through a tissue sample (biopsy) to have prostate cancer of a specific type called adenocarcinoma
• People who meet at least 2 of these 3 cancer severity markers: a Gleason score (aggressiveness rating) of 8 or higher; cancer classified as T3 or T4 stage (meaning it has grown beyond the prostate); or a PSA (prostate-specific antigen) blood level of 20 ng/mL or higher
• People whose prostate is smaller than 100 cc as measured by MRI scan
• People whose blood test results meet the following levels: white blood cell count (neutrophils) at or above 1.5 x 10⁹/L; platelet count at or above 100 x 10⁹/L; haemoglobin (red blood cell measure) at or above 90 g/L, without having had a blood transfusion in the 4 weeks before joining
• People whose liver function blood tests are within acceptable ranges (ALT and/or AST no more than 2.5 times the upper limit of normal; bilirubin no more than 1.5 times the upper limit of normal)
• People whose kidney function blood test (creatinine) is no more than 2 times the upper limit of normal
• Sexually active people who agree to use effective contraception during treatment and for 1 week after the last dose
• People who are covered by a social security system or equivalent private health insurance, as required by local regulations for clinical trial participation
• People who are willing and able to follow the trial schedule, including all treatments, visits, tests, and follow-up appointments

Who may not be able to join:

• People who have detectable cancer spread (metastasis), including any evidence of spread to pelvic lymph nodes shown on advanced imaging (PSMA PET/CT scan) or enlarged pelvic lymph nodes (1 cm or larger) on MRI (note: people with very small lymph node changes below 1 cm and unclear findings on advanced imaging may still be considered — confirm with trial site)
• People who have had a prostate procedure called a TURP or prostate enucleation within the past 6 months (people with severe urinary symptoms will be carefully assessed to determine whether such a procedure is needed before joining)
• People who have previously received treatment for prostate cancer — such as surgical removal of the prostate, radiation, or hormone therapy started more than 6 weeks before joining — with the exception of lymph node surgery in people confirmed to have no cancer in those lymph nodes
• People with other serious or uncontrolled medical conditions or active infections, such as active hepatitis, HIV, or chronic liver disease, that could affect safe participation
• People with certain heart or blood pressure conditions, including uncontrolled high blood pressure (consistently at or above 160/95 mmHg), recent stroke, heart failure, serious heart rhythm problems, active heart disease, a heart attack within the past year, or bypass surgery
• People with uncontrolled diabetes
• People with active liver or bile duct disease (though Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease may be acceptable — confirm with trial site)
• People with digestive system conditions or prior gut procedures that could significantly interfere with absorbing the study medication, or serious bowel conditions that would make pelvic radiation unsafe
• People with severely reduced lung function (confirm with trial site for specific test thresholds)
• People who have had another cancer in the past 3 years, with the exception of a type of skin cancer called basal cell carcinoma
• People with a known allergy or sensitivity to the study treatment or any of its components
• People with physical or psychological conditions that, in the investigator's judgement, would prevent them from safely following the study procedures
• People who have previously had prostate surgery, prostate radiotherapy, or any pelvic radiation that would make further prostate or pelvic radiotherapy impossible
• People currently taking, or planning to take, certain medications that strongly affect how the body processes the study drug (strong inhibitors or inducers of a liver enzyme called CYP450 3A4/5); a one-week break from such medications may be required before joining
• People who have previously been treated with certain advanced hormone-blocking medications for prostate cancer (second-generation androgen receptor inhibitors, experimental AR inhibitors, or CYP17 enzyme inhibitors)
• People currently using oestrogens, 5-alpha reductase inhibitors, or androgen receptor inhibitors
• People who still have unresolved side effects (above a mild level) from any previous treatments
• People who have previously received chemotherapy or immunotherapy for prostate cancer
• People who have had major surgery within 28 days before joining the trial
• People who have participated in another treatment trial within 30 days before joining
• People who are under legal custody, protective custody, or guardianship
• People who are unwilling or unable to attend the required medical follow-up due to geographic, family, social, or psychological reasons

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