Clinical trial NCT05806814: Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Official title: Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Keywords: antigen presenting cells (APCs)
Sipuleucel-T (Sip-T)
granulocyte-macrophage colony-stimulating factor (GM-CSF)
prostatic acid phosphatase (PAP)
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Dendreon
First posted: 2023-04-10
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The primary objective is to evaluate the feasibility and immune response of an extended course of Sipuleucel-T immunotherapy given at week 0, 2, and 12-14 in patients with metastatic castration-resistant prostate cancer.
Primary purpose: TREATMENT

Brief summary: Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

Detailed description: This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.

Eligibility criteria: Inclusion Criteria:

1. Men ≥ 18 years of age
2. Prostate cancer with history of metastasis
3. Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy of ≥ 6 months

Exclusion Criteria:

1. Previously received Sipuleucel-T (Provenge®)
2. Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
3. A requirement for systemic immunosuppressive therapy (\>10mg Prednisone daily or equivalent)
4. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
5. Any infection requiring antibiotic therapy within 1 week prior to registration

Primary outcomes:
measure: Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
timeFrame: up to 5 months
measure: Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
timeFrame: up to 12 Months
Secondary outcomes:
measure: Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.
timeFrame: up to 12 months
measure: Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.
timeFrame: up to 12 Months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center, Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: Investigator
name: Kelly Stratton, MD
role: PRINCIPAL_INVESTIGATOR
References: