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 to take part, understand what the study involves, and are able to sign a consent form in person.
• People who are at least 18 years old at the time of signing the consent form.
• People who have been diagnosed with prostate cancer confirmed by a tissue or cell sample (not the neuroendocrine or small cell type).
• People whose recent PSMA PET/CT scan (a type of imaging test) showed a positive result.
• People whose testosterone levels have been reduced to very low levels through treatment, but whose cancer has continued to grow — shown by rising PSA blood test results, growth of soft tissue tumours, or new bone lesions.
• People whose cancer has previously stopped responding to at least one newer hormone-blocking treatment (such as enzalutamide, apalutamide, or abiraterone) and to taxane-based chemotherapy. People who are considered unsuitable for further taxane chemotherapy, or who decline it, may also be considered (confirm with trial site).
• People whose scans during the screening period (within 4 weeks before starting treatment) showed one or more areas where the cancer has spread.
• People whose blood test results show that their bone marrow, liver, and kidneys are working well enough — within specific ranges set by the trial (confirm with trial site for exact values).
• People with an overall physical functioning score of 0 to 2 on a standard medical scale (meaning they are fully active to capable of limited self-care).
• People whose life expectancy is expected to be longer than six months.
• People who are willing to use condoms during sex throughout the study and for 18 weeks after the last dose, and who agree not to donate sperm during that time.

Who may not be able to join:

• People who have received systemic or local radioisotope therapy within the six months before starting the trial, or who have previously had any treatment that specifically targets PSMA.
• People who have received systemic anti-cancer treatments (such as chemotherapy, immunotherapy, or certain targeted therapies) within 28 days before starting the trial, or within five half-lives of the drug used — whichever is the shorter period. People who have had external beam radiation therapy within 28 days (except for palliative radiation), or certain traditional Chinese medicine anti-tumour treatments within two weeks, are also excluded.
• People who have previously experienced severe bone marrow suppression from cancer treatment, specifically a grade 4 level or a grade 3 level that took more than six weeks to recover from, or who have had radiation to a large area of their bone marrow (more than 25%) in the past. People who received a blood transfusion within 28 days before starting the trial are also excluded.
• People whose side effects from previous cancer treatments have not recovered to a mild level (grade 1 or lower), except for hair loss (any grade is acceptable) and nerve-related symptoms in the hands or feet (which must have recovered to grade 2 or lower).
• People who have taken part in another interventional clinical trial within 28 days before starting this trial, or within five half-lives of the investigational drug — whichever is shorter.
• People with a known allergic reaction to the imaging agent or treatment drug used in this trial, or to similar substances.
• People with untreated active cancer spread to the brain or the lining of the brain. People who have had brain metastases that were previously treated and are now stable, symptom-free, and not requiring steroids or anti-seizure medication for at least 28 days may be considered.
• People with spinal cord compression that is causing symptoms, or where scans suggest it is about to occur. People who have already been treated for spinal cord compression and are now stable with no ongoing neurological problems may be considered.
• People whose bone scans during screening show unusual abnormalities beyond what is expected (confirm with trial site).
• People with claustrophobia or other conditions — such as being unable to lie flat or stay still — that would prevent them from completing the required scans.
• People whose veins are assessed as too difficult to use for the repeated blood samples required in the pharmacokinetic (drug monitoring) part of the study — this applies only to those taking part in that specific sub-study.
• People with serious uncontrolled medical conditions that could affect their safety in the trial, including severe heart failure, certain heart rhythm conditions, serious active infections requiring intravenous treatment, or active hepatitis B or C infections meeting specific criteria.
• People with another active cancer that could affect life expectancy or make it harder to assess the prostate cancer. People with a history of another cancer who have been fully treated and have been cancer-free and treatment-free for more than three years may be considered, as may people with fully treated non-melanoma skin cancer or superficial bladder cancer.
• People with bladder outlet obstruction or urinary incontinence that cannot be managed with available treatments such as pads or catheterisation.
• People with any physical or mental health condition that the investigating doctor believes could affect their safety or their ability to follow the treatment plan.

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