Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: * Asymptomatic or minimally symptomatic metastatic prostate cancer, and the diagnosis of prostate cancer needs to be histologically confirmed by biopsy of the prostate or a metastatic lesion * On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression based on the prostate cancer working group (PCWG) 3 criteria * Age 18 or above * ECOG performance status 0 or 1 * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count ≥1,000/mcL * Platelets ≥100,000/mcL * Hemoglobin \> 10 g/dl * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * Creatinine 1.5 ≤ institutional ULN * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV vir…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source