Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer
Advanced ChemoHormonal Therapy for Treatment Naïve Metastatic Prostate Cancer: Apalutamide and Abiraterone Acetate With Prednisone and Androgen Deprivation Therapy After Treatment With Docetaxel and Androgen Deprivation Therapy
Sponsor: OHSU Knight Cancer Institute + Janssen Scientific Affairs, LLC, Oregon Health and Science University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Complete prostate specific antigen (PSA) response
Time frame: At 12 months from the start of treatment
Secondary Endpoints
Overall survival
Incidence of adverse events >= grade 2
Proportion of patients with PSA response >= 50% decrease
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically or cytologically confirmed prostate cancer OR a strong suspicion of prostate cancer as evidenced by metastatic disease in a pattern consistent with prostate cancer (such as blastic lesions on a nuclear medicine bone scan or lymphadenopathy on the computed tomography \[CT\] scan) AND a PSA \> 50 ng/mL * Patients must meet either of the definitions for high risk disease as follows: * Definition 1: Must have at least 2 of the following 3 at the time diagnosed metastatic: * visceral metastatic disease * \>=3 bone lesions * Gleason 8-10 OR * Definition 2: \>=4 bone lesions, including \>=1 outside of the vertebral column or pelvis and/or visceral metastatic disease * If a patient has received androgen deprivation therapy (ADT) for neoadjuvant or adjuvant therapy at least 24 months MUST have elapsed since its use to day 1 of restarting ADT for metastatic castration sensitive disease * ADT sensitive disease- no evidence…
Read full criteria on CT.gov →✦ Analyst Commentary
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