Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer
Sponsor: M.D. Anderson Cancer Center
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Composite radiographic progression-free survival(rPFS) and biochemical (PSA) progression-free survival (PFS)
Time frame: From randomization until progression, death, or last assessment without progression, whichever comes first, assessed at 3 years
Secondary Endpoints
Incidence and severity of adverse events (AEs)
Incidence and severity of serious adverse events (SAEs)
Overall survival
Eligibility Criteria
Inclusion Criteria: * Completion of informed consent prior to any study specific procedures. Consent may be done remotely. * Patients must agree to tissue collection for correlative studies at the specified timepoints * Male aged 18 years and above * Histologically or cytologically confirmed prostate carcinoma * Localized or regional high-risk disease as defined by at least one of the following features: Prostate specific antigen (PSA) \> 20 ng/mL, T3a or higher, grade group 4-5 (i.e. Gleason score ≥ 8) as per National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 2.2020 for high risk or very high risk prostate cancer, and/or regional lymph nodes positive for prostate cancer * Planned for definitive treatment of local regional prostate cancer using XRT and androgen ablation * Willing to undergo ongoing medical castration to maintain testosterone levels of ≤ 50 ng/dL (≤ 2.0 nM) throughout systemic treatment or have undergone bilateral orchiectomy * Eastern Cooperative Onc…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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