Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer | NCT00715104

Name	Class
University of California, San Francisco	OTHER

Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer | NCT00715104 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sipuleucel-T with Booster	Experimental	Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.	Biological: Sipuleucel-T with Booster
Sipuleucel-T without Booster	Experimental	Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.	Biological: Sipuleucel-T without Booster

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sipuleucel-T with Booster	Biological	Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject	CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.	Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)

Secondary Outcomes

Measure	Description	Time Frame
Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject	CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

Contacts/Locations Module

Name	Affiliation	Role
Andy Sandler, MD	Dendreon	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
USC / Norris Comprehensive Cancer Center		Los Angeles	California	90033	United States
UCSF Comprehensive Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27216195	Derived	Sheikh N, Cham J, Zhang L, DeVries T, Letarte S, Pufnock J, Hamm D, Trager J, Fong L. Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects. Cancer Res. 2016 Jul 1;76(13):3711-8. doi: 10.1158/0008-5472.CAN-15-3173. Epub 2016 May 23.

Label	URL
Prostate Cancer Research Institute	View source

Arm/Group Information

ID	Title	Description
FG000	Sipuleucel-T With Booster	Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
FG001	Sipuleucel-T Without Booster	Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
FG002	Sipuleucel-T Without Randomization to Booster	Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00018 subjects FG00116 subjects FG0028 subjects
COMPLETED		FG00018 subjects FG00116 subjects FG0028 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Sipuleucel-T With Booster	Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
BG001	Sipuleucel-T Without Booster

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.

Results are not presented by arm because all assessments were performed prior to randomization to booster.

Posted

Mean

Standard Error

cells/μm2

Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)

ID	Title	Description
OG000	Biopsy Benign Tissue	Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sipuleucel-T With Booster	Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ARRHYTHMIA	Cardiac disorders	MedDRA	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Lynn Ngo	Dendreon Corporation	206-274-6763		lngo@dendreon.com

Condition Browse Module

ID	Term
D011471	Prostatic Neoplasms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Intervention Browse Module

ID	Term
C511774	sipuleucel-T
D007117	Immunization, Secondary

ID	Term
D007114	Immunization
D007167	Immunotherapy
D056747	Immunomodulation
D001691	Biological Therapy

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.	Chi-squared	1.000	Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.	% Subjects with 2-fold increase	16.2	2-Sided	95	1.7	30.7	No	Superiority or Other
OG000 OG002	A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.	Chi-squared	1.000	Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.	% Subjects with 2-fold increase	18.9	2-Sided	95	3.5	34.3	No	Superiority or Other
OG000 OG003	A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.	Chi-squared	<0.001	Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.	% Subjects with 2-fold increase	70.3	2-Sided	95	52.3	88.3	No	Superiority or Other

Secondary

Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.

Results are not presented by arm because all assessments were performed prior to randomization to booster

Posted

Mean

Standard Error

cells/μm2

Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)

ID	Title	Description
OG000	Biopsy Benign Tissue	Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
OG001	Post-RP Benign Tissue	Benign tissue from post-treatment with sipuleucel-T and post-RP
OG002	Post-RP Tumor Tissue	Tumor tissue from post-treatment with sipuleucel-T and post-RP
OG003	Post-RP Tumor Interface Tissue	Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP

Units	Counts
Participants	OG00036 OG00136 OG00236 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.93± 0.24 OG0010.43± 0.09 OG0020.74± 0.13 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.	Chi-squared		1.000	Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.	% subjects with 2-fold increase	20.6			2-Sided	95	4.0	37.2

Secondary

Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.

Results are not presented by arm because all assessments were performed prior to randomization to booster

Posted

Mean

Standard Error

cells/μm2

Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)

ID	Title	Description
OG000	Biopsy Benign Tissue	Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
OG001	Post-RP Benign Tissue	Benign tissue from post-treatment with sipuleucel-T and post-RP
OG002	Post-RP Tumor Tissue	Tumor tissue from post-treatment with sipuleucel-T and post-RP
OG003	Post-RP Tumor Interface Tissue	Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP

Units	Counts
Participants	OG00037 OG00137 OG00237 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.65± 0.08 OG0010.94± 0.14 OG0020.88± 0.12 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.	Chi-squared		0.002	Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.	% subjects with 2-fold increase	35.1			2-Sided	95	16.3	53.9

Secondary

Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood

Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays.

This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150-7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells.

All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.

Results are not presented by arm because all assessments were performed prior to randomization to booster.

Posted

Mean

Standard Error

numbers of spots

Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)

ID	Title	Description
OG000	Baseline	ELISPOT for PA2024 at baseline
OG001	Pre-RP Visit	ELISPOT for PA2024 at Pre-RP Visit
OG002	6 Weeks Post-RP	ELISPOT for PA2024 at 6 Weeks post-RP
OG003	12 Weeks Post-RP	ELISPOT for PA2024 at 12 Weeks post-RP

Units	Counts
Participants	OG00033 OG00128 OG00223 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004.9± 2.4 OG00156.6± 14.9 OG00226.5± 9.1 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.	Mixed Models Analysis	Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.	<0.001	P value is for the visit effect in the mixed model					2-Sided							No	Superiority or Other

Secondary

Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood

Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.

All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.

Results are not presented by arm because all assessments were performed prior to randomization to booster.

Posted

Mean

Standard Error

numbers of spots

Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)

ID	Title	Description
OG000	Baseline	ELISPOT for PAP at baseline
OG001	Pre-RP Visit	ELISPOT for PAP at pre-RP visit
OG002	6 Weeks Post-RP	ELISPOT for PAP at 6 Weeks post-RP
OG003	12 Weeks Post-RP	ELISPOT for PAP at 12 Weeks post-RP

Units	Counts
Participants	OG00033 OG00128 OG00223 OG00329

Title

Denominators

Categories

Title	Measurements
	OG0002.2± 1.7 OG00113.3± 4.9 OG0022.0± 1.2 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	Repeated measure analysis of variance (ANOVA) methods with a mixed model approach was used. The ranked data were used in the statistical model.	Mixed Models Analysis	Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.	0.173	P value is for the visit effect in the mixed model					2-Sided							No	Superiority or Other

Secondary

Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.

The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).

Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.

Posted

Mean

Standard Error

numbers of spots

12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

ID	Title	Description
OG000	12 Weeks Post-RP/Pre-Booster	ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
OG001	24 Weeks Post-RP	ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
OG002	48 Weeks Post-RP	ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
OG003	72 Weeks Post-RP	ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster

Units	Counts
Participants	OG00016 OG00112 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG00035.6± 14.9 OG00125.6± 9.7 OG00223.5± 13.1 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.	Mixed Models Analysis		0.667	P value compares 24 week post-RP to pre-booster (12 weeks post RP)					2-Sided							No	Superiority or Other

Secondary

Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.

The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.

Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.

Posted

Mean

Standard Error

number of spots

12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

ID	Title	Description
OG000	12 Weeks Post-RP/Pre-Booster	ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
OG001	24 Weeks Post-RP	ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
OG002	48 Weeks Post-RP	ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
OG003	72 Weeks Post-RP	ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster

Units	Counts
Participants	OG00016 OG00112 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009.2± 5.4 OG0010.3± 0.9 OG0026.2± 4.8 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.	Mixed Models Analysis		0.086	P value compares 24 week post-RP to pre-booster (12 weeks post RP)					2-Sided							No	Superiority or Other

Secondary

Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups

The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.

Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.

Posted

Mean

Standard Error

number of spots

12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

ID	Title	Description
OG000	Booster: 12 Weeks Post-RP/Pre-Booster	ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
OG001	No Booster: 12 Weeks Post-RP/Pre-Booster	ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
OG002	Booster: 24 Weeks Post-RP	ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
OG003	No Booster: 24 Weeks Post-RP	ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to no booster
OG004	Booster: 48 Weeks Post-RP	ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
OG005	No Booster: 48 Weeks Post-RP	ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
OG006	Booster: 72 Weeks Post-RP	ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
OG007	No Booster: 72 Weeks Post-RP	ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster

Units	Counts
Participants	OG00016 OG00110 OG00212 OG003

Title

Denominators

Categories

Title	Measurements
	OG00035.6± 14.9 OG00181.7± 44.4 OG00225.6± 9.7 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007	The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.	Mixed Models Analysis	Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.	0.950	P value is based on the treatment effect in the mixed model					2-Sided							No

Secondary

Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups

The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.

Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.

Posted

Mean

Standard Error

numbers of spots

12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

ID	Title	Description
OG000	Booster: 12 Weeks Post-RP/Pre-Booster	ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
OG001	No Booster: 12 Weeks Post-RP/Pre-Booster	ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
OG002	Booster: 24 Weeks Post-RP	ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
OG003	No Booster: 24 Weeks Post-RP	ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to no booster
OG004	Booster: 48 Weeks Post-RP	ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
OG005	No Booster: 48 Weeks Post-RP	ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to no booster
OG006	Booster: 72 Weeks Post-RP	ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
OG007	No Booster: 72 Weeks Post-RP	ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to no booster

Units	Counts
Participants	OG00016 OG00110 OG00212 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009.2± 5.4 OG00120.2± 13.9 OG0020.3± 0.9 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007	The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.	Mixed Models Analysis	Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect	0.048	P value is based on the treatment effect in the mixed model					2-Sided							No