Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Conditions
Keywords
Single Dose, Sipuleucel-T, Immune Response Rate, Safety, Adenocarcinoma of the Prostate
Brief summary
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Detailed description
Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.
Interventions
DRUGSipuleucel-T Injection
Single Infusion
Sponsors
WCG IRB
Talosix
Dendreon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
AN OPEN-LABEL, MULTICENTER STUDY OF SUBJECTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER TREATED WITH PROVENGE AND BOOSTED WITH A SINGLE INFUSION OF SIPULEUCEL-T TO MEASURE IMMUNE RESPONSE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For a subject to be eligible for participation in this study, all of the following criteria must be satisfied: 1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer). 2. Have qualified for on-label PROVENGE® infusion 3. Have received all 3 infusions of PROVENGE® prior to randomization 4. Written informed consent provided prior to the initiation of study procedures 5. Estimated life expectancy ≥12 months
Exclusion criteria
A subject will not be eligible for participation in this study if any of the following criteria apply. 1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer). 2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1) 3. Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment. 4. On experimental or investigational therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess humoral immune response to PAP and PA2024 after booster infusion | Once all subjects have completed the study through the 5 year Overall Survival Period | To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T | Once all subjects have completed the study through the 5 year Overall Survival Period | For all subjects enrolled in the study. Evaluation will include descriptive statistics by treatment arm and in the aggregate of the incidence of adverse events (Number of participants with adverse events (AEs), and the incidence of clinically significant laboratory abnormalities (Number of participants experiencing clinically significant laboratory abnormalities) after initial treatment and booster (Week 28) within and between groups. |
| Evaluate Overall Survival | Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating | Overall survival after booster infusion of sipuleucel-T defined as the time from randomization to death due to any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess biomarkers of response to treatment | Once all subjects have completed the study through the 5 year Overall Survival Period | Biomarkers, such as cytokines, will be assessed for response to booster treatment using appropriate descriptive statistics assessed over time and at Week 28. Nominal p-values will be provided without multiplicity adjustment .appropriate descriptive statistics assessed over time and at Week 28. |
| Assess Antigen Response | Once all subjects have completed the study through the 5 year Overall Survival Period | Comparison of (over time and at Week 38), the number of subjects per treatment arm with PAP and PA2024 antigen positive response using descriptive statistics. |
Countries
United States
Contacts
Primary ContactMargaret Warner-Lubin
Outcome results
None listed