Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

Study Overview
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Brief Summary
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A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Detailed Description
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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.

Official Title
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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

Conditions
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Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Intervention / Treatment
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* Drug: Sipuleucel-T Injection


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Booster Arm<br>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<br>* Single Infusion<br>|
| No Intervention: No Booster<br>No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess humoral immune response to PAP and PA2024 after booster infusion | 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 | Once all subjects have completed the study through the 5 year Overall Survival Period | 
| Geometric Mean Ration of the difference in Humor Response | 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 | Once all subjects have completed the study through the 5 year Overall Survival Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T | 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. | Once all subjects have completed the study through the 5 year Overall Survival Period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Dose, Sipuleucel-T, Immune Response Rate, Safety, Adenocarcinoma of the Prostate