Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
A Dynamic Allocation Modular Sequential Trial of Approved and Promising Therapies in Men With Metastatic Castrate Resistant Prostate Cancer
Sponsor: M.D. Anderson Cancer Center + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall survival (OS)
Time frame: Up to 4 years
Incidence of adverse events as measured by the method of Thall et al
Time frame: Up to 4 years
Androgen receptor (AR) response marker signature
Time frame: At baseline
Allocation serum marker decline
Time frame: At 8 weeks
Secondary Endpoints
Time to treatment failure (TTF)
Eligibility Criteria
Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study: 1. Willing and able to provide written informed consent. 2. Male aged 18 years and above. 3. Histologically or cytologically confirmed adenocarcinoma of the prostate. 4. Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans). 5. Patients must have documented evidence of progressive disease as defined by any of the following: a) PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least \>/= 1.0 ng/mL; b) New or increasing non-bone disease (RECIST 1.1 criteria); c) Positive bone scan with 2 or more new lesions (PCWG3). 6. Surgically or ongoing medically castrated, with baseline testosterone levels of ≤ 50 ng/dL (≤ 2.0 nM). 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2. 8. Hemoglobin ≥ 7.5 g/dL in the presence of bone marrow involvement independent of transf…
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