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:

• People who are willing and able to give their informed consent before any study procedures begin, and who are willing to follow all study requirements.
• People who are 18 years of age or older.
• People who have a confirmed diagnosis (proven by tissue biopsy) of one of the following cancers: castration-resistant prostate cancer (CRPC), colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple-negative breast cancer, or oesophageal squamous cell cancer.
• People with CRPC whose cancer has continued to grow or spread despite having very low testosterone levels, shown by rising PSA blood tests, growth of tumours on scans, new bone lesions on bone scans, or new lesions found on a specialised prostate imaging scan (PSMA PET).
• People with CRPC whose cancer has spread to other parts of the body, confirmed either by standard scans (CT or MRI) or by a specialised PSMA PET scan.
• People with CRPC who have already been treated with hormone-blocking therapy (ADT) and at least one additional prostate cancer hormone drug (such as enzalutamide, apalutamide, darolutamide, or abiraterone).
• People with CRPC who have previously received one course of taxane-based chemotherapy (at least two cycles), though this is not required.
• People whose cancer has continued to grow or spread during or after their most recent cancer treatment, and who have either tried standard treatments without success, cannot tolerate standard treatments, or have no standard treatments available that are likely to help.
• People (excluding those with CRPC) who have at least one tumour that can be measured on a scan according to standard measurement guidelines (RECIST v1.1).
• People who are reasonably well and able to carry out daily activities, rated as 0, 1, or 2 on a standard scale used by doctors to assess general health and function (ECOG performance status).
• People who, in their doctor's opinion, are expected to live for at least 4 months.
• People who could become pregnant must have a negative pregnancy blood test and must not be breastfeeding at the time of joining.
• People who could become pregnant must agree to use a highly effective form of contraception during the study and for 6 months after the last dose of the study drug.
• Male participants who are capable of fathering a child must agree to use a highly effective form of contraception during the study and for 6 months after the last dose of the study drug, and must not donate sperm during this time.
• People who received radiation therapy more than 28 days before the first dose of the study drug may be eligible to participate.
• People who have previously been treated for brain metastases (cancer that has spread to the brain) may be eligible if their brain condition has been stable on scans for at least 28 days before starting the study drug, they do not need steroid medications to manage brain-related symptoms (or are on a low stable dose of no more than 10 mg/day of prednisone or equivalent), and they have no history of cancer spreading along the lining of the brain or spinal cord compression.
• People with liver metastases may be eligible if there are no more than 3 lesions, all lesions are 2 cm or smaller in size, and the lesions show a certain level of activity on a specialised scan (confirm with trial site).

Who may not be able to join:

• People who have previously had an organ transplant.
• People who currently have another active cancer diagnosis, with the exception of previously treated cervical pre-cancer or certain non-melanoma skin cancers (some people with a history of other low-risk cancers may be considered on a case-by-case basis).
• People who have a medical condition that, in their doctor's opinion, would prevent them from safely or fully taking part in the study — for example, severe claustrophobia that cannot be managed with medication, significant back pain that makes lying on a scanning table difficult, or inability to lie still for imaging procedures.
• People who still have side effects rated Grade 2 or higher from previous cancer treatment (except for hair loss or mild nerve-related symptoms in the hands or feet).
• People with a history of serious allergic reactions, or who are known or expected to be allergic to protein-based medicines or to the study drug or its ingredients.
• People whose organ function tests (blood tests) fall outside acceptable ranges, including kidney function, blood cell counts, liver function, or blood clotting measures (confirm specific values with trial site).
• People who have needed a blood transfusion within 2 weeks before the first dose of the study drug.
• People with CRPC who have previously been treated with a radioactive medicine that targets PSMA (Lu-177-PSMA therapy).
• People with significant heart problems, including unstable chest pain, a heart attack within the past 6 months, moderate to severe heart failure, certain abnormal heart rhythms or electrical patterns on a heart tracing (ECG), reduced heart pumping function, or a specific abnormality in the heart's electrical timing found on a screening ECG (confirm details with trial site).
• People who are currently participating in another clinical treatment trial for their cancer.
• People who are pregnant or breastfeeding.
• People who have had major surgery within 4 weeks before the first dose of the study drug.
• People who have received any cancer treatment — including chemotherapy, immunotherapy, radiation, biological therapies, herbal therapies, or other experimental treatments — within 28 days (or within a shorter timeframe for certain biological drugs) before the first dose of the study drug.
• People with a currently active hepatitis B or hepatitis C infection (some people with a history of hepatitis B or C who meet specific conditions may be considered — confirm with trial site).
• People with any other serious uncontrolled illness or infection that requires treatment with systemic medicines.
• People with untreated moderate to severe kidney obstruction (hydronephrosis), unless it has been corrected by a medical procedure such as a stent or nephrostomy.
• People with CRPC who have a particular pattern on a bone scan called a "superscan," which suggests very widespread bone involvement (confirm with trial site).
• People with an active autoimmune disease that has required systemic treatment within the past 90 days (routine hormone replacement therapy at stable low doses is generally permitted — confirm with trial site).
• People with any other significant health conditions that, in their doctor's opinion, could affect their safety, their ability to follow the study plan, or the reliability of the study results.

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