Actively Recruiting
AtezoCab: Phase II Study of Cabozantinib Plus Atezolizumab in Men With Metastatic Castration-Resistant Prostate Cancer With Non-Measurable Disease
Led by University of Utah · Updated on 2026-06-05
33
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating cabozantinib and atezolizumab in men with metastatic castration-resistant prostate cancer (mCRPC) that has spread beyond the pelvis. This phase II trial explores whether this combination can shrink tumors and control disease in patients with non-measurable metastatic cancer. The study also aims to assess treatment effects on prostate-specific antigen (PSA) levels, radiographic progression, overall survival, safety, and biomarkers related to treatment response and resistance. Patients receive cabozantinib orally once daily for 21 days and atezolizumab intravenously on day 1 of each 21-day cycle. Treatment continues until disease progression or unacceptable side effects occur. After finishing study treatment, patients are followed up at 30 days and then every three months until disease progression or new therapy begins. During the study, patients will have their disease control rate assessed at 24 weeks. Researchers will monitor PSA progression-free survival, PSA 50% response rate, radiographic progression-free survival, overall survival, and adverse events. Tissue and tumor biomarkers will be analyzed to understand how the treatment works and why resistance may occur. Safety and treatment effects are closely monitored throughout the trial, which may last up to several years for some participants.
CONDITIONS
Brief Title
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subject aged �3E= 18 years
- Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
- Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state
- Non-measurable disease outside the pelvis per RECIST 1.1 criteria
- Disease progression on or after at least one prior novel hormonal therapy
- ECOG performance status �3C= 2
- Effective castration with serum testosterone �3C= 0.5 ng/mL
- Tumor tissue available or approved by Principal Investigator
- Adequate blood counts and liver, kidney function as specified
- Use of medically accepted contraception during and up to 5 months after treatment
- Able to provide informed consent and comply with protocol
You will not qualify if you...
- Prior chemotherapy in metastatic castration refractory prostate cancer setting
- Previous treatment with cabozantinib, immune checkpoint inhibitors, or systemic immunostimulatory agents recently
- Recent use of kinase inhibitors or other systemic anticancer therapy
- Receiving other investigational agents
- Measurable disease outside the pelvis
- History of leptomeningeal disease or uncontrolled tumor-related pain
- Recent radiation therapy or surgery with incomplete healing
- Other active malignancies requiring treatment
- Known brain metastases unless stable and asymptomatic
- Use of certain anticoagulants
- Recent live attenuated vaccine
- Uncontrolled significant illnesses including cardiovascular, gastrointestinal, infections
- Active autoimmune diseases except well-controlled exceptions
- Recent systemic immunosuppressive medication beyond allowed exceptions
- Severe infections or active infections requiring treatment
- Hepatitis B or C, HIV with uncontrolled infection
- History of certain pulmonary conditions
- Serious non-healing wounds or malabsorption syndrome
- Moderate to severe hepatic impairment or dialysis
- History of organ or stem cell transplant
- Uncontrolled effusions requiring frequent drainage
- Uncontrolled hypercalcemia
- Prolonged QT interval or risk factors for arrhythmias
- Inability to swallow tablets or receive IV infusion
- Severe allergic reactions to study drug components
- Medical or psychiatric conditions compromising consent or compliance
- Use of prohibited medications without appropriate washout period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive cabozantinib orally once daily on days 1-21 and atezolizumab intravenously on day 1 of each 21-day cycle, repeated until disease progression or unacceptable toxicity.
1 visit per 21-day cycle (in-person)
Duration - Up to approximately 5 years
After completing study treatment, participants are followed up at 30 days and then every 3 months until disease progression or start of another therapy.
1 visit at 30 days and then visits every 3 months
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
S
Susan Sharry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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