This trial is for patients diagnosed with localized prostate cancer who have not yet received any active treatment and are planning on pursuing active surveillance as their treatment.
Trial Description The purpose of the ProVent clinical trial is to evaluate the effectiveness of sipuleucel-T treatment in reducing the progression of lower risk non-metastatic prostate cancer compared with patients being followed on active surveillance. Sipuleucel-T (Provenge) has been previously FDA-approved for use in metastatic castrate resistant prostate cancer.
This is an open-label study, meaning that both patients and researchers are aware of the treatment that participants are receiving. Patients enrolled in this study will be randomly (by chance) assigned to one of two arms. The first will receive sipuleucel-T treatment and the second will be followed on active surveillance. Following completion of either study arm, patients will be follow-up with every 6 months until study completion.
ProVent is a phase 3 clinical trial that will enroll 450 participants. The trial began in 2018 and the primary completion date is in 2023. Possible patient benefits include slowing down or stopping the progression of prostate cancer. Patients will also be monitored under close medical supervision for safety during the study period. Possible patient risks: The use of sipuleucel-T will provide no benefit to newly diagnosednon-metastatic patients for preventing disease progression.