Immunotherapy for Prostate Cancer
Sequence of Agents
➤ ➤ Sipuleucel-T first. (90%)
➤ ➤ An androgen receptor-targeted agent (such as abiraterone acetate or
enzalutamide) first, followed by sipuleucel-T. (10%)
➤ ➤ One of the two approaches above should be used prior to radium and
chemotherapy. (100%)
➤ ➤ When sipuleucel-T is used, it should be used as the first treatment if all
standard eligibility criteria are met. (100%)
Sipuleucel-T
➤ ➤ The guidelines for use of sipuleucel-T as provided in the Full Prescribing
Information ('package insert'), including recommendations on laboratory
parameters, should be followed.
Note: Patients do not require clinical evaluation prior to each cellular infusion if
the previous one was uncomplicated.
➤ ➤ Standard PSA and radiologic monitoring should be followed. (80%) (C)
➤ ➤ Obtain new baseline PSA and imaging immediately after completing
infusions. (20%) (C)
Therapy Subsequent to Sipuleucel-T
➤ ➤ The FDA has drafted guidance for industry concerning treatment after
disease progression when using therapeutic cancer vaccines. (A)
(See US Food and Drug Administration. Guidance for Industry: Clinical
Considerations for Therapeutic Cancer Vaccines. 2011. https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-bio-gen/documents/document/ucm278673.pdf.
Accessed 1 Mar 2017)
➤ ➤ Wait for an event/progression before beginning a subsequent therapy.
(60%)
➤ ➤ Depends on individual patient characteristics and the pace of the disease.
(30%)
➤ ➤ Move to a new therapy immediately. (10%)
This option was recommended as part of a two-part approach whereby
sipuleucel-T is followed by enzalutamide.
➤ ➤ Infusions should be continued even when an increased interval between
doses is clinically necessary.
