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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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Immunomodulating Agents

Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 peripheral blood mononuclear cells (PBMCs) per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

sipuleucel-T

Robert Israel, MD

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.

To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

A Randomized, Multicenter, Single Blind Study in Men With Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen

An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.

Dendreon

Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.

Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 peripheral blood mononuclear cells (PBMCs) per mL

Cohort A

Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL

Cohort B

Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL

Cohort C

Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

ECOG 0=Fully Active; No restrictions

ECOG 1= Restricted Strenuous Activity

ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead

Eastern Cooperative Oncology Group (ECOG) performance status

Gleason Score ≤ 6

Gleason Score =7

Gleason Score ≥ 8

Missing information

Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.

Gleason Score

Shabnam Vaziri

The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).

Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.

Spots Global Cancer Trial Database for To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

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