Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Conditions
Keywords
antigen presenting cells (APCs), Sipuleucel-T (Sip-T), granulocyte-macrophage colony-stimulating factor (GM-CSF), prostatic acid phosphatase (PAP)
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.
Interventions
BIOLOGICALSipuleucel-T
Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.
Sponsors
University of Oklahoma
Dendreon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy. | up to 5 months | Patients will be treated with Sipuleucel-T immunotherapy and the treatment regimen will be considered feasible if 85% of enrolled patients complete all three infusions of Sipuleucel-T treatment given at week 0, 2 and 12-14. |
| 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. | up to 12 Months | For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the changes in immune response will be measured based on the detectable elevated levels of IgG and/or T-cell proliferation against various types of prostate cancer associated antigens at baseline, and at Sipuleucel-T infusion doses given at week 0, 2 and 12-14 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups. | up to 12 months | Potential difference of immune response to Sipuleucel-T immunotherapy given at weeks 0, 2 and 12-14 will be compared in patients with mCRPC of different racial groups using the one-way ANOVA or the Kruskal-Wallis test. |
| Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose. | up to 12 Months | For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the preliminary tumor response will be measure through the comparison of serum PSA level between baseline and within 30 days of last dose. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKelly Stratton, MD
Investigator
Outcome results
None listed