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 have been diagnosed with prostate cancer (specifically a type called adenocarcinoma) that has spread to other parts of the body, is no longer responding to hormone-lowering treatments, and is getting worse over time.
• People who are male and are at least 18 years old at the time of signing consent.
• People whose testosterone levels are very low (below 50 ng/dL), either because of surgery to remove the testicles or because they are on ongoing hormone-lowering injections or implants.
• People whose prostate cancer has already gotten worse despite taking at least one of the newer hormone-blocking medicines, such as abiraterone, apalutamide, darolutamide, or enzalutamide.
• People whose side effects from previous cancer treatments have mostly resolved to a mild level, with exceptions allowed for hair loss and some nerve-related symptoms.
• People who have had radiotherapy in the past, as long as the last treatment was more than 2 weeks before starting the trial, and they have fully recovered from any radiation-related side effects.
• People who have at least one area of cancer that shows up on a special type of scan called a PSMA PET scan.
• People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard medical scale).
• People whose blood, liver, and kidney test results are within acceptable ranges for this trial.
• People who are willing and able to use effective contraception during the trial and for at least 6 months after the last dose of treatment.
• People who are willing to follow recommended safety precautions related to radiation during the study.
• People who are willing to have a tumour tissue sample (biopsy) taken, though this requirement may be waived by the treating doctor if no safely accessible area is available.
• People who have previously been treated for cancer that has spread to the brain, provided it was treated more than 28 days before starting the trial, there are no signs of new or worsening brain tumours on a recent MRI scan, and no steroid treatment has been needed for at least 14 days before the trial starts.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial.
• People who are able to understand the study information and are willing to sign a consent form.

Who may not be able to join:

• People who have been diagnosed from the start with a specific subtype of prostate cancer called small cell neuroendocrine prostate cancer (though cases where this subtype appeared later during treatment may still be considered).
• People who have areas of cancer visible on a standard CT scan that do not show up on the PSMA PET scan (confirm with trial site for size thresholds).
• People who have received other systemic (whole-body) cancer treatments within 14 days, or within 5 half-lives of the drug (whichever comes first), before starting the trial — except for ongoing hormone-lowering injections.
• People who have brain tumours that have not yet been treated.
• People who have previously received any treatment specifically targeting the PSMA protein on cancer cells, such as targeted radiotherapy, immunotherapy, or a type of drug called an antibody-drug conjugate.
• People who have previously been treated with certain types of immunotherapy drugs that work by targeting immune checkpoint proteins (such as PD-1, PD-L1, PD-L2, CTLA-4, OX40, or CD137).
• People who are currently in another clinical trial or have used an experimental treatment or device within the past 4 weeks before starting this trial.
• People who have previously received more than 2 courses of chemotherapy drugs from the taxane family (such as docetaxel or cabazitaxel).
• People who have had a severe allergic reaction (Grade 3 or higher) to the drug pembrolizumab or any of its ingredients.
• People who have an active autoimmune disease that has required systemic medical treatment (such as immune-suppressing drugs) within the past 2 years. Standard hormone replacement therapies are not considered a reason for exclusion.
• People who have an immune deficiency condition, or who have been taking steroid medications above a certain dose, or other immune-suppressing treatments within the past 7 days before starting the trial.
• People who have a history of significant lung inflammation (pneumonitis or interstitial lung disease at Grade 2 or higher) that required steroid treatment within the past 2 years, or who currently have any level of active lung inflammation at the time of enrolment.
• People who have received a live or live-weakened vaccine within 30 days before starting the trial (non-live vaccines are permitted).
• People who are unable to give valid informed consent due to age, medical condition, psychiatric condition, or physical status.
• People who have significant heart or blood vessel problems, including uncontrolled heart failure, uncontrolled chest pain, a heart attack or stroke in the past 6 months, or serious heart rhythm problems that cannot be controlled with medication.
• People who have had prior radiotherapy covering more than 25% of the bone marrow, or who have had any such radiotherapy within 14 days before starting the trial.
• People who have had major surgery within 28 days before starting the trial, or who have not fully recovered from a recent major surgery.
• People who have an active infection that is currently being treated with antibiotics given through a drip (intravenously) within 7 days before starting the trial.
• People who have a known history of active Hepatitis B or Hepatitis C infection, unless specific treatment conditions have been met and the virus is no longer detectable in the blood (confirm with trial site).
• People who have a known history of active tuberculosis (TB).
• People who have known psychiatric conditions or substance use problems that would make it difficult to follow the trial requirements.
• People who have a history of abnormal bleeding and who are currently on blood-thinning medication that cannot be safely stopped for the biopsy procedure.
• People who have any other condition that, in the trial doctor's judgement, would prevent them from safely following the study procedures.

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