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 male and at least 18 years old at the time of signing the consent form
• People who have been diagnosed with a type of prostate cancer called adenocarcinoma and/or neuroendocrine carcinoma, confirmed through a tissue sample examination
• People whose cancer has spread to other parts of the body, as shown on imaging scans such as bone scans, CT scans, or MRI scans
• People whose cancer meets at least one of the following "aggressive variant" features: small cell (neuroendocrine) prostate cancer confirmed by biopsy; cancer that has spread only to internal organs (such as the liver or lungs); bone spread that is mostly breaking down bone rather than forming new bone; large lymph nodes (5 cm or bigger) or large masses in the pelvis or prostate area; a PSA level of 10 ng/ml or lower when the cancer has already spread widely (20 or more sites); certain elevated blood markers (LDH at least twice the upper normal limit, or CEA at least twice the upper normal limit); or cancer that stopped responding to hormone therapy within 6 months or less
• People who agree to use contraception throughout treatment and for the required period after the last dose, and who agree not to donate sperm during this time
• People who are willing and able to provide written consent to take part in the trial
• People who have at least one tumour that can be measured on scans, using standard measurement guidelines (confirm with trial site)
• People who are able to provide a tumour tissue sample — either one collected within the past year or a newly obtained biopsy from a tumour that has not been previously treated with radiation; tissue preserved in a standard laboratory block format is preferred
• People who are rated as fully active or restricted only in physically demanding activity on a standard health performance scale (called ECOG score 0 or 1), assessed within 7 days before the first dose
• People whose liver, kidneys, bone marrow, and other organs are functioning well enough, based on blood tests taken within 10 days before starting treatment
• People with a history of Hepatitis B who have been on antiviral treatment for at least 4 weeks and have no detectable virus in their blood before starting the trial, and who are willing to remain on antiviral therapy throughout the study
• People with a history of Hepatitis C who have no detectable virus in their blood at screening and who have completed curative antiviral treatment at least 4 weeks before starting the trial

Who may not be able to join:

• People who have previously received certain types of immunotherapy treatments that target the immune system's checkpoint proteins (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar therapies)
• People who have received any systemic cancer treatment, including experimental treatments, within 4 weeks before signing consent
• People who have previously been treated with cabazitaxel or carboplatin
• People who have had radiation therapy within 2 weeks before starting the trial, or who have not fully recovered from radiation side effects, or who needed steroids because of radiation, or who have had radiation-related lung problems (a shorter 1-week waiting period may apply for limited palliative radiation to areas outside the brain — confirm with trial site)
• People who have received a live or live-weakened vaccine within 30 days before the first dose (vaccines using inactivated/killed viruses are permitted)
• People who are currently taking part in, or have recently taken part in, another clinical trial using an experimental treatment or device within the past 4 weeks
• People who have an immune system deficiency, or who are taking steroid medicines at a dose higher than 10 mg of prednisone (or equivalent) per day, or who are on other immune-suppressing medicines within 7 days before the first dose
• People who have another cancer that is currently active or has needed treatment within the past 5 years (certain skin cancers that have been successfully treated may still be eligible — confirm with trial site)
• People who have active cancer spread to the brain or the lining around the brain; people with previously treated brain metastases may be considered if the cancer has been stable for at least 4 weeks on repeat scans and they have not needed steroids for at least 14 days
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab, carboplatin, cabazitaxel, or any of their ingredients
• People who have an autoimmune disease that has needed systemic medical treatment within the past 2 years (hormone or gland replacement therapies are generally not considered systemic treatment and are typically permitted — confirm with trial site)
• People who have a history of lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition
• People who have an active infection that requires treatment through the bloodstream (such as intravenous antibiotics)
• People who have moderate to severe heart failure (NYHA Class 2 or higher)
• People who have significant hearing loss (Grade 2 or higher)
• People who have a known HIV infection
• People who have both active Hepatitis B and active Hepatitis C infections at the same time
• People who have a mental health condition or substance use problem that would make it difficult to follow the trial requirements
• People who have received an organ or tissue transplant from another person
• People whose overall health, other medical conditions, or other circumstances mean that taking part would not be in their best interest, as judged by the treating doctor

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