ProvONE: Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Study Details
Study Description
Brief Summary
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Booster Arm Experimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events. |
Drug: Sipuleucel-T Injection
Single Infusion
|
| No Intervention: No Booster No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events. |
Outcome Measures
Primary Outcome Measures
- 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
- Geometric Mean Ration of the difference in Humor Response [Once all subjects have completed the study through the 5 year Overall Survival Period]
The difference in humoral response to PAP and/or PA2024 after booster infusion (measured approximately 2 weeks after receipt of booster) assessed by Geometric Mean Ratio of the difference between humoral response at each timepoint and after booster within and between the groups.Subjects will be evaluated for IgG and IgM antibody responses by an Enzyme-Linked Immunosorbent Assay (ELISA) and both the antibody titer as well as percent maintaining an antibody response, as determined by number of subjects with an antibody titer greater that the 9th percentile at baseline, will be compared between booster and control arms
Secondary Outcome Measures
- 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.
Other Outcome Measures
- 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 antigen positive response using descriptive statistics.
Eligibility Criteria
Criteria
Inclusion Criteria:
For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:
-
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).
-
Have qualified for on-label PROVENGE® infusion
-
Have received all 3 infusions of PROVENGE® prior to randomization
-
Written informed consent provided prior to the initiation of study procedures
-
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.
-
Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
-
Need for systemic chronic immunosuppressive therapy (eg, antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids).
-
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.
-
On experimental or investigational therapy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Dendreon
Investigators
- Study Director: Nadeem Sheikh, PhD, Dendreon Pharmaceuticals, LLC
- Study Chair: Benjamin Lowentritt, MD, Chesapeake Urology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P23-1