SIPULEUCEL-T INJ,SUSP
Clinical Criteria Summary
Exclusion Criteria
- Unable to comply with a minimum of 3 leukapheresis appointments (scheduled every 2 weeks for 3 visits, may be more depending on cell collection)
- Contraindication to apheresis (e.g., active infection, unstable heart or lung condition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or more
- Visceral metastases
- Pathologic bone fractures
- Spinal cord compression
- Previous treatment with chemotherapy or secondary hormonal therapy for prostate cancer within the past 90 days
- Requires opioid therapy for cancer-related pain due to lack of efficacy of prior non-opiate pain regimens (not intolerance)
- Requires concomitant immunosuppressive therapy (exception: replacement doses of steroids <30mg/day Hydrocortisone or <7.5mg/day Prednisone or equivalent)
- Average weekly prostate cancer-related pain score of 4 or more on a 10-point visual analog scale
Inclusion Criteria
- Patient has been offered a referral for concurrent Palliative Care to assess goals of care
- Metastatic castrate resistant prostate cancer with progressive disease based on soft tissue and/or bony metastases on serial radiographs, or PSA progression (two consecutive PSA values at least 14 days apart, each ≥5.0 ng/mL and ≥50% above the minimum PSA obtained during castration therapy)
- Asymptomatic or minimally symptomatic metastatic disease
- Alternative therapies have been discussed with patient
- Concomitant medical or surgical castration (serum testosterone ≤ 50 ng/dL) started at least 3 months prior to sipuleucel-T
Dosage and Administration / Clinical Requirements
- Recommended course consists of 3 complete doses given at approximately 2-week intervals
- Leukapheresis procedure required approximately 3 days prior to each dose to collect cells for incubation with an antigen
- Pre-medicate approximately 30 minutes prior to infusion with acetaminophen and diphenhydramine to minimize infusion reactions
- Infusion administered over 60 minutes; do not use a cell filter
- Observe patient for at least 30 minutes after each infusion
- If a scheduled dose is missed, another apheresis procedure is required if the treatment course is to be continued