Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer (NCT05168618) | Clinical Trial Compass
RecruitingPhase 2
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer
United States33 participantsStarted 2022-03-29
Plain-language summary
This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male subject aged \>= 18 years
* Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
* Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state
* Patient must have non-measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria. Non-measurable disease can be bone lesions and/or extraskeletal disease
* Disease progression on or after at least one prior novel hormonal therapy (NHT) (defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, darolutamide)
* Eastern Cooperative Oncology Group (ECOG) performance Status =\< 2
* Effective castration with serum testosterone levels =\< 0.5 ng/mL (=\<1.7 nmol/L)
* Tumor tissue available (archival or recent tumor biopsy). If no tumor tissue is available, patients can be enrolled after approval from Principal Investigator.
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 without granulocyte colony-stimulating factor support
* White blood cell count \>= 2500/uL
* Lymphocyte count \>= 0.5 x 10\^9/L (500/uL)
* Platelet count \>= 100,000/mm\^3 without transfusion in the 2 weeks prior to cycle 1 day 1 (C1D1)
* Hemoglobin \>= 9 g/dL
* Serum albumin \>= 2.5 g/dl
* For patients not receiving therapeutic anticoagulation: prothrombin time (PT)/International normalized ratio (INR) or partial thromboplastin time (PTT) test \< 1.5 x …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.