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Updated: May 30, 2026
A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with
Simon J Hall1, Laurence Klotz, Allan J Pantuck
1Department of Urology, Mount Sinai School of Medicine, New York, New York 10029, USA. Simon.Hall@mountsinai.org
Purpose:
We describe the safety of sipuleucel-T using an integrated analysis of 4 randomized, controlled studies in patients with prostate cancer.
Materials And Methods:
Adverse events, survival data and laboratory evaluations were examined for common, rare and latent events.
Results:
In 5% or more of sipuleucel-T cases some adverse events were reported at a rate at least twice that in controls, including chills in 53.1%, pyrexia in 31.3%, headache in 18.1%, myalgia in 11.8%, influenza-like illness in 9.7% and hyperhidrosis in 5.0%. These events generally occurred within 1 day of infusion, were grade 1 or 2 in severity and resolved in 2 days or less. The incidence of serious adverse events reported was 24.0% in sipuleucel-T cases and 25.1% in controls. Grade 3 or greater adverse events were reported within 1 day of infusion in 40 of 601 sipuleucel-T cases (6.7%) and 7 of 303 controls (2.3%). The incidence rate of reported cerebrovascular events was 3.5% for sipuleucel-T cases and 2.6% in controls.
Conclusions:
Sipuleucel-T therapy in patients with prostate cancer has a side effect profile that is characterized by mild to moderate, short-term, reversible adverse events. There was no evidence of a treatment related increase in autoimmune complications or secondary malignancies after treatment with sipuleucel-T. Sipuleucel-T can be administered safely in the outpatient setting.
Insights
Sipuleucel-T therapy for prostate cancer shows a safety profile with mild, short-term side effects. Integrated analysis of clinical trials confirms its safety in outpatient settings.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Prostate cancer remains a significant health concern.
- Sipuleucel-T is an autologous cellular immunotherapy used for prostate cancer treatment.
- Understanding the safety profile of sipuleucel-T is crucial for patient management.
Purpose of the Study:
- To evaluate the safety of sipuleucel-T in patients with prostate cancer.
- To analyze adverse events, survival data, and laboratory evaluations from randomized, controlled studies.
Main Methods:
- Integrated analysis of four randomized, controlled studies.
- Examination of adverse events, including common, rare, and latent events.
- Assessment of survival data and laboratory evaluations.
Main Results:
- Common adverse events (chills, pyrexia, headache) occurred more frequently with sipuleucel-T but were mild and transient.
- The incidence of serious adverse events was comparable between sipuleucel-T and control groups.
- No increased risk of autoimmune complications or secondary malignancies was observed.
Conclusions:
- Sipuleucel-T exhibits a favorable safety profile characterized by manageable, short-term adverse events.
- The immunotherapy is safe for administration in an outpatient setting.
- Clinical trial data support the continued use of sipuleucel-T in prostate cancer patients.
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