Name of the Procedure:

• Common Name(s): Sipuleucel-T infusion
• Technical Terms: Sipuleucel-T, autologous active cellular immunotherapy

Summary

Sipuleucel-T infusion is an advanced cancer treatment that leverages the patient's immune cells to fight prostate cancer. This personalized therapy involves extracting white blood cells, activating them to target cancer, and reintroducing them into the patient’s body to help attack the cancer cells.

Purpose

Conditions Addressed:

• Metastatic castrate-resistant prostate cancer (mCRPC)

Goals/Expected Outcomes:

• To enhance the body's immune response against prostate cancer cells
• To potentially extend the survival time of the patient
• To help manage and slow the progression of the disease

Indications

Symptoms/Conditions:

• Advanced prostate cancer not responding to hormone therapy
• Prostate cancer that has spread to other parts of the body

Patient Criteria:

• Diagnosis of mCRPC confirmed by a healthcare professional
• Adequate health to withstand the treatment process

Preparation

Pre-Procedure Instructions:

• No fasting required
• Inform your doctor about all medications and supplements you are taking
• Follow specific instructions regarding any medications that need to be paused or adjusted

Diagnostic Tests/Assessments:

• Blood tests to assess overall health and organ function
• Imaging tests to confirm the extent of cancer spread

Procedure Description

Steps:

1. Leukapheresis:
   • Blood is drawn from the patient.
   • White blood cells (including CD54+ cells) are separated and collected.
2. Cell Activation:
   • Collected cells are sent to a laboratory where they are exposed to a protein called PAP-GM-CSF (Prostatic Acid Phosphatase linked to Granulocyte-Macrophage Colony-Stimulating Factor).
   • This activation process makes them target prostate cancer cells.
3. Reinfusion:
   • The activated cells are infused back into the patient intravenously.

Tools/Technology:

• Leukapheresis machine
• Intravenous (IV) infusion setup

Anesthesia/Sedation:

• No anesthesia or sedation is typically required

Duration

• Each leukapheresis session: ~2-4 hours
• Each infusion session: ~1 hour

Setting

• Outpatient clinic or hospital

Personnel

• Oncologists
• Specialized nurses
• Laboratory technicians

Risks and Complications

Common Risks:

• Chills
• Fever
• Fatigue
• Nausea

Rare Complications:

• Infusion reactions
• Allergic responses
• Blood clotting issues

Management:

• Monitoring by healthcare professionals
• Medications to mitigate side effects

Benefits

• Potential to bolster the body’s natural defenses against prostate cancer
• May extend survival time and improve quality of life
• Benefits may be realized several weeks to months after treatment

Recovery

Post-Procedure Care:

• Rest and hydration
• Monitoring for any adverse reactions to the infusion

Expected Recovery Time:

• Most patients can resume normal activities shortly after each session
• Regular follow-ups as determined by the healthcare provider

Alternatives

Other Treatment Options:

• Hormone therapy
• Chemotherapy
• Radiation therapy
• Targeted therapy

Pros and Cons:

• Sipuleucel-T is less invasive than surgery or radiation
• Offers a personalized approach compared to general chemotherapy
• Alternatives might have different side effects and efficacy profiles

Patient Experience

During Procedure:

• Mild discomfort during leukapheresis
• IV placement and infusion typically well-tolerated

After Procedure:

• Possible mild symptoms like fever or chills
• Fatigue may persist for a short period
• Healthcare team provides support and symptom management strategies