Neuroendocrine carcinoma of prostate Trials in Disease

Study of Pembrolizumab, Carboplatin, and Cabazitaxel for Patients with Aggressive Metastatic Castration-Resistant Prostate Cancer

This clinical trial is testing a combination of three different medications for patients with an aggressive form of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone levels. The study combines pembrolizumab, an immunotherapy drug that helps the immune system fight cancer, with two chemotherapy drugs: carboplatin and cabazitaxel. These chemotherapy medications work by stopping cancer cells from growing and dividing.

Main inclusion criteria:

• Male participants aged 18 years or older
• Confirmed diagnosis of prostate cancer, specifically adenocarcinoma or neuroendocrine carcinoma
• Metastatic disease confirmed by imaging tests such as bone scans, CT scans, or MRI scans
• Must meet at least one criterion for aggressive variant prostate cancer, such as proven neuroendocrine cancer, spread to internal organs, certain types of bone metastases, large lymph nodes, low PSA levels with extensive disease, high levels of certain blood markers, or quick progression to treatment resistance
• Adequate organ function as determined by laboratory tests
• ECOG performance status of 0 to 1, meaning the disease does not significantly limit daily activities
• Measurable disease based on specific criteria
• Provision of a recent tumor tissue sample or willingness to undergo a new biopsy
• Agreement to use contraception during treatment and for a specified period afterward

Main exclusion criteria:

• Presence of a different type of cancer than the one being studied
• Absence of confirmed metastatic castration-resistant prostate cancer diagnosis
• Female patients (study is limited to male participants)
• Vulnerable populations unable to provide informed consent

Focus and goal of the trial:

The main purpose of this study is to evaluate whether the combination of pembrolizumab, carboplatin, and cabazitaxel is effective and safe for treating this aggressive form of prostate cancer. The medications are given directly into a vein through an intravenous infusion. Researchers will monitor how long the cancer can be controlled without getting worse, known as progression-free survival. Throughout the study, participants will undergo regular imaging tests, such as CT or MRI scans, along with blood tests and other assessments to check the status of the cancer and ensure patient safety.

Investigational drugs:

Pembrolizumab is an immunotherapy medication that helps the immune system recognize and attack cancer cells by blocking a protein called PD-1. It is given as an intravenous infusion.

Carboplatin is a platinum-based chemotherapy drug that damages the DNA inside cancer cells, preventing them from growing and dividing. It is administered directly into the bloodstream through a vein.

Cabazitaxel is a taxane chemotherapy drug that interferes with structures inside cancer cells that are needed for them to divide and grow. It is also given as an intravenous infusion.