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:

• Men aged 18 or older who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed by a tissue sample test.
• People who are reasonably active and able to care for themselves, and whose doctors estimate they have at least 6 months to live.
• People whose prostate cancer has spread to other parts of the body, confirmed by a CT scan, MRI, or bone scan.
• People whose cancer has continued to grow despite having very low testosterone levels — either through surgical removal of the testicles or ongoing hormone-lowering injections — and whose testosterone blood level is below a specific threshold at the time of screening.
• People who have received at least 12 weeks of a specific type of hormone therapy drug (such as abiraterone, apalutamide, darolutamide, or enzalutamide) and whose cancer has progressed while on the most recent one of these drugs. Some prior docetaxel chemotherapy (used for early spreading cancer) may be permitted if at least 4 cycles were given and the last dose was at least 6 months before screening.
• People whose cancer is still progressing at the time of study entry, shown by either two rising PSA blood test results (with the most recent being at least 2.0 ng/mL), or by new or growing areas of cancer seen on scans.
• People whose cancer shows a positive result on a specific type of scan called a 68Ga-PSMA-11 PET/CT or PET/MRI, where the cancer cells show sufficient uptake of a marker protein called PSMA, as reviewed and confirmed by an independent imaging review team appointed by the study sponsor.
• People who have recovered from significant side effects of previous treatments, with most side effects having improved to a mild or moderate level (Grade 2 or lower), except for hair loss.
• People with adequate blood counts, liver function, and kidney function at screening, including: platelets at or above 150×10⁹/L; neutrophil count at or above 1.5×10⁹/L; haemoglobin above 10 g/dL without a recent blood transfusion; liver enzyme and bilirubin levels within acceptable ranges; and kidney function (creatinine clearance) of at least 45 mL/min.
• People who understand the study requirements and are willing to follow all study procedures.
• People who are willing and able to follow radiation safety rules required by the treating institution, to protect others — particularly any female partner who is or may be pregnant.
• People who agree to use appropriate contraception to prevent pregnancy in a partner during the study, in line with recommended guidelines to reduce radiation exposure risks to an unborn child.

Who may not be able to join:

• People who are unable or unwilling to give written informed consent, or who are unlikely to follow the study procedures in the investigator's opinion.
• People whose prostate cancer includes small cell cancer or any cancer type other than adenocarcinoma (a small amount of neuroendocrine features, less than 20%, may be acceptable — confirm with trial site).
• People with a history of another cancer that could significantly affect life expectancy or interfere with study assessments, unless: the prior cancer has been fully treated and has not returned for at least 3 years; it was a non-melanoma skin cancer that was adequately treated; or it was a superficial bladder cancer that is stable and controlled.
• People who have previously received treatment with specific antibody-based therapies targeting PSMA (such as J591, HuJ591, or any other PSMA-targeted therapy).
• People who have previously received chemotherapy for castration-resistant or non-metastatic prostate cancer (earlier docetaxel use for cancer that had spread may be acceptable if conditions above are met).
• People who have a known allergy or intolerance to the study drug or any of its ingredients.
• People who have received other systemic cancer treatments (such as chemotherapy, immunotherapy, or radiation therapy) within 4 weeks of enrolling, or who are currently receiving other cytotoxic, immunotherapy, radioligand, or experimental treatments (ongoing hormone-lowering therapy is generally permitted — confirm with trial site).
• People who have received radioactive treatments (such as strontium-89, radium-223, or similar) within 6 months before enrolling.
• People who have taken part in another experimental drug study within 4 weeks of enrolling.
• People with known brain tumour spread measuring 1 cm or larger, liver tumour spread measuring 1 cm or larger, or certain bone lesions measuring 1 cm or larger.
• People who have had a seizure or stroke within the past 6 months.
• People showing signs — on examination or imaging — that the spinal cord is at risk of being compressed, or who are already experiencing spinal cord compression symptoms.
• People with a serious active infection, significant heart problems (such as certain classes of heart failure, a substantially prolonged heart rhythm interval, or unstable chest pain), or serious illness affecting the heart, lungs, brain, kidneys, liver, or blood, that could interfere with completing the study or be affected by the study treatment.
• People who have previously been treated with PARP inhibitor drugs (such as olaparib) or with platinum-based chemotherapy drugs.

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