Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With Metastatic Castration-Resistant Prostate Canc (mCRPC)
- Conditions
- Metastatic Prostate Cancer, Prostate Adenocarcinoma
- Registration Number
- JPRN-jRCT2011200005
- Lead Sponsor
- Kimura Akiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 575
Men with histologically or cytologically confirmed adenocarcinoma of the prostate
-Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or metastatic Castration-sensitive prostate cancer (mCSPC), Non-metastatic Castration-resistant prostate cancer (M0 CRPC), or mCRPC
-Surgical or medical castration, with serum testosterone =< 50 ng/dL (=< 1.73 nmol/L) at screening
-Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
-Progressive disease (PD) at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible)
-Age >= 18 years old or meeting country definition of adult, whichever is older, on the day of consent
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-Recovery to baseline or =< Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator
-Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization
-Understanding and ability to comply with protocol requirements
-Any prior nonhormonal therapy initiated for the treatment of mCRPC
-Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
-Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization (subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible)
-Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization
-Symptomatic or impending spinal cord compression or cauda equina syndrome
-Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
-Administration of a live, attenuated vaccine within 30 days prior to randomization
-Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization
-Uncontrolled, significant intercurrent or recent illness
-Major surgery within 4 weeks prior to randomization
-Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram(ECG) within 21 days before randomization
-Inability or unwillingness to swallow pills or receive IV administration
-Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies
-Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method