Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men aged 18 or older
• People who have been confirmed through tissue or cell testing to have prostate adenocarcinoma (a specific type of prostate cancer), but not the small cell type
• People whose cancer has spread (metastatic) and continued to grow despite ongoing hormone-suppression treatment
• People whose cancer has spread to areas outside the pelvis, but where the affected areas are considered non-measurable by standard medical imaging criteria (this can include bone lesions or other non-bone spread outside the pelvis) (confirm with trial site)
• People whose cancer got worse during or after at least one prior advanced hormonal therapy, such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide
• People who are generally able to carry out basic daily activities, with only mild limitations at most (based on a standard medical scoring scale)
• People whose testosterone levels are being kept very low through treatment (at or below 0.5 ng/mL)
• People who have tumour tissue available from a previous biopsy or a new one — if no tissue is available, the lead researcher may still consider enrolment
• People whose blood cell counts, kidney function, liver function, and other blood markers fall within the ranges required by the trial (confirm specific values with trial site)
• People who are willing and able to use approved contraception during the study and for 5 months after the last dose of study treatment
• Men who agree to use a condom during sexual activity for the entire time they are on the study treatment
• People who have recovered from side effects of any previous cancer treatment, or whose remaining side effects are minor or well managed
• People who are able to understand and agree to the study's consent process and are willing and able to follow the study requirements

Who may not be able to join:

• People who have previously received chemotherapy for castration-resistant prostate cancer (chemotherapy given earlier, during hormone-sensitive disease, may be allowed — confirm with trial site)
• People who have previously been treated with cabozantinib, certain immune-boosting drugs (CD137 agonists), or immune checkpoint therapies such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies
• People who received certain immune-stimulating treatments (such as interferon or interleukin-2) within approximately 4–5 weeks before starting the study
• People who received certain targeted small molecule therapies within 2 weeks before the first dose
• People who received other systemic cancer treatments within 4 weeks before the first dose
• People currently taking part in another clinical trial with an investigational treatment
• People whose cancer has spread to areas outside the pelvis in a way that is measurable by standard imaging criteria (confirm with trial site)
• People who have had cancer spread to the membranes surrounding the brain or spinal cord
• People experiencing severe, uncontrolled cancer-related pain
• People who have had radiation therapy to bone within 2 weeks, other radiation therapy within 4 weeks, or radioactive drug treatments within 6 weeks before the first dose — or who have ongoing significant complications from prior radiation
• People who have had major surgery within 4 weeks before the first dose, minor surgery within 10 days before the first dose, or who have not fully healed from surgery, or who are expected to need major surgery during the study
• People who currently have, or have been diagnosed with, another cancer within the past 3 years that still requires active treatment — with some exceptions for certain low-risk, apparently cured skin cancers or similar conditions
• People with known cancer spread to the brain or the area around the brain or spinal cord, unless it has been successfully treated and has been stable for at least 4 weeks, the person has no neurological symptoms, and no steroid treatment is needed (confirm with trial site)
• People taking certain blood-thinning medications such as warfarin, dabigatran, betrixaban, or clopidogrel — some other blood thinners may be permitted (confirm with trial site)
• People who have received a live vaccine within 30 days before starting the study or who would need one during the study period or within 5 months after the last dose
• People with serious uncontrolled heart conditions, including certain types of heart failure, unstable chest pain, serious irregular heart rhythms, or a history of stroke, heart attack, or blood clots within the past 6 months (some exceptions may apply — confirm with trial site)
• People with persistently high blood pressure that is not controlled despite treatment
• People with certain serious stomach or bowel conditions, including active ulcers, inflammatory bowel disease, or a history of bowel perforation or abdominal abscess within the past 6 months
• People with any other condition the trial doctor considers a safety concern for participation
• People with a recent history of significant bleeding (more than half a teaspoon of red blood) within 12 weeks before the first dose
• People with certain lung lesions or disease affecting the airways
• People whose cancer is growing into or wrapping around major blood vessels
• People with a clinically significant history of autoimmune diseases (conditions where the immune system attacks the body), with some exceptions such as well-controlled type 1 diabetes, thyroid conditions managed with replacement hormones, or certain mild skin conditions (confirm with trial site)
• People who need regular systemic steroid or immune-suppressing medication, with some limited exceptions (confirm with trial site)
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting the study, or who currently have an active infection requiring systemic treatment
• People with active or chronic hepatitis B or C, HIV/AIDS-related illness, or active tuberculosis — although people with HIV who have an undetectable viral load on effective treatment may be eligible (confirm with trial site)
• People with a history of certain lung scarring or inflammation conditions, or with signs of active lung inflammation on a recent scan
• People with serious non-healing wounds, ulcers, or bone fractures
• People with a condition that prevents proper absorption of food or medication from the gut
• People with uncontrolled or symptomatic low thyroid function
• People with moderate to severe liver impairment
• People who require dialysis
• People who have had an organ transplant or stem cell transplant from a donor
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained more than once a month (some exceptions for people with certain indwelling drainage devices — confirm with trial site)
• People with uncontrolled or symptomatic high calcium levels in the blood
• People with a specific heart rhythm measurement (QTcF) above 500 ms on a heart tracing, or a history of certain heart rhythm risk factors
• People who are unable to swallow tablets or unable to receive treatment through an intravenous (IV) drip
• People with a history of severe allergic reactions to certain types of antibody-based medicines
• People with a known allergy to Chinese hamster ovary cell products or to any ingredient in the study drug atezolizumab
• People with a known allergy to any component of the study treatments, or a history of severe reactions to similar medicines — or people with certain rare inherited conditions affecting sugar processing
• People whose mental, psychiatric, cognitive, or other health conditions may make it difficult to understand the study, give consent, or follow the study requirements
• People taking certain prohibited medications that cannot be stopped or changed before starting the study

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