Trial Outcomes & Findings for Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer (NCT NCT00715104)
NCT ID: NCT00715104
Last Updated: 2015-05-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Results posted on
2015-05-04
Participant Flow
The study was conducted across 6 sites in the US. Screening and enrollment occurred from Sept 2008 - Dec 2012. 42 subjects were registered. 41 subjects received at least 1 sipuleucel-T infusion prior to radical prostatectomr (RP),18 subjects were randomized to the booster group,15 were randomized to the no booster group; and 8 were not randomized.
Participant milestones
| Measure |
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.
|
Sipuleucel-T Without Booster
Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
8
|
|
Overall Study
COMPLETED
|
18
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Sipuleucel-T With Booster
n=18 Participants
Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
|
Sipuleucel-T Without Booster
n=16 Participants
Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
|
Sipuleucel-T Without Randomization to Booster
n=8 Participants
Subjects received 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).
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
8 participants
n=5 Participants
|
42 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)Population: 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.
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.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=37 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=37 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=37 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=37 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
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
|
2.33 cells/μm2
Standard Error 0.34
|
2.03 cells/μm2
Standard Error 0.19
|
1.98 cells/μm2
Standard Error 0.18
|
6.39 cells/μm2
Standard Error 0.61
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)Population: 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
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.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=36 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=36 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=36 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=36 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
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
|
0.93 cells/μm2
Standard Error 0.24
|
0.43 cells/μm2
Standard Error 0.09
|
0.74 cells/μm2
Standard Error 0.13
|
3.83 cells/μm2
Standard Error 0.49
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)Population: 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
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.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=37 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=37 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=37 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=37 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
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
|
0.65 cells/μm2
Standard Error 0.08
|
0.94 cells/μm2
Standard Error 0.14
|
0.88 cells/μm2
Standard Error 0.12
|
2.87 cells/μm2
Standard Error 0.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)Population: 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.
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.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=33 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=28 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=23 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=29 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
|
4.9 numbers of spots
Standard Error 2.4
|
56.6 numbers of spots
Standard Error 14.9
|
26.5 numbers of spots
Standard Error 9.1
|
52.3 numbers of spots
Standard Error 17.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)Population: 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.
Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=33 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=28 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=23 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=29 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
|
2.2 numbers of spots
Standard Error 1.7
|
13.3 numbers of spots
Standard Error 4.9
|
2.0 numbers of spots
Standard Error 1.2
|
12.8 numbers of spots
Standard Error 5.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RPPopulation: Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.
The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).
Outcome measures
| Measure |
Biopsy Benign Tissue
n=16 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=12 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=13 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=10 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.
|
35.6 numbers of spots
Standard Error 14.9
|
25.6 numbers of spots
Standard Error 9.7
|
23.5 numbers of spots
Standard Error 13.1
|
18.0 numbers of spots
Standard Error 5.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RPPopulation: Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.
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.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=16 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=12 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=13 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=10 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.
|
9.2 number of spots
Standard Error 5.4
|
0.3 number of spots
Standard Error 0.9
|
6.2 number of spots
Standard Error 4.8
|
0.4 number of spots
Standard Error 1.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RPPopulation: 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.
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.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=16 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=10 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=12 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=12 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
n=13 Participants
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
n=11 Participants
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
n=10 Participants
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
n=14 Participants
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups
|
35.6 number of spots
Standard Error 14.9
|
81.7 number of spots
Standard Error 44.4
|
25.6 number of spots
Standard Error 9.7
|
22.3 number of spots
Standard Error 9.2
|
23.5 number of spots
Standard Error 13.1
|
19.5 number of spots
Standard Error 9.3
|
18.0 number of spots
Standard Error 5.0
|
12.6 number of spots
Standard Error 3.7
|
SECONDARY outcome
Timeframe: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RPPopulation: 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.
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.
Outcome measures
| Measure |
Biopsy Benign Tissue
n=16 Participants
Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
|
Post-RP Benign Tissue
n=10 Participants
Benign tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Tissue
n=12 Participants
Tumor tissue from post-treatment with sipuleucel-T and post-RP
|
Post-RP Tumor Interface
n=12 Participants
Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
|
Booster: 48 Weeks Post-RP
n=13 Participants
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
|
No Booster: 48 Weeks Post-RP
n=11 Participants
ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
|
Booster: 72 Weeks Post-RP
n=10 Participants
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
|
No Booster: 72 Weeks Post-RP
n=14 Participants
ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
|
|---|---|---|---|---|---|---|---|---|
|
Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups
|
9.2 numbers of spots
Standard Error 5.4
|
20.2 numbers of spots
Standard Error 13.9
|
0.3 numbers of spots
Standard Error 0.9
|
4.8 numbers of spots
Standard Error 1.6
|
6.2 numbers of spots
Standard Error 4.8
|
2.7 numbers of spots
Standard Error 1.7
|
0.4 numbers of spots
Standard Error 1.0
|
1.9 numbers of spots
Standard Error 1.7
|
Adverse Events
Sipuleucel-T Without Booster
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Sipuleucel-T With Booster
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Sipuleucel-T Without Randomization to Booster
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sipuleucel-T Without Booster
n=16 participants at risk
Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
|
Sipuleucel-T With Booster
n=18 participants at risk
Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.
|
Sipuleucel-T Without Randomization to Booster
n=8 participants at risk
Subjects received 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).
|
|---|---|---|---|
|
Cardiac disorders
ARRHYTHMIA
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Eye disorders
VISION BLURRED
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Nervous system disorders
DIZZINESS
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Psychiatric disorders
DISORIENTATION
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
Other adverse events
| Measure |
Sipuleucel-T Without Booster
n=16 participants at risk
Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
|
Sipuleucel-T With Booster
n=18 participants at risk
Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.
|
Sipuleucel-T Without Randomization to Booster
n=8 participants at risk
Subjects received 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).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
CONTUSION
|
18.8%
3/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
FALL
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
GASTROENTERITIS RADIATION
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
TOOTH INJURY
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
12.5%
2/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
12.5%
2/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Investigations
HAEMATOCRIT DECREASED
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.2%
1/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
12.5%
2/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS STENOSANS
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/16
|
11.1%
2/18
|
12.5%
1/8
|
|
Nervous system disorders
HEADACHE
|
25.0%
4/16
|
33.3%
6/18
|
0.00%
0/8
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Nervous system disorders
MIGRAINE
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/16
|
5.6%
1/18
|
25.0%
2/8
|
|
Nervous system disorders
PARAESTHESIA ORAL
|
25.0%
4/16
|
33.3%
6/18
|
12.5%
1/8
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
25.0%
4/16
|
16.7%
3/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.2%
1/16
|
16.7%
3/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
18.8%
3/16
|
0.00%
0/18
|
37.5%
3/8
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.2%
1/16
|
16.7%
3/18
|
25.0%
2/8
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Cardiac disorders
CARDIAC FLUTTER
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Eye disorders
CONJUNCTIVITIS
|
6.2%
1/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Eye disorders
EYE SWELLING
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Eye disorders
SCLERAL HAEMORRHAGE
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Eye disorders
VITREOUS DETACHMENT
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.2%
1/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Gastrointestinal disorders
DIARRHOEA
|
12.5%
2/16
|
11.1%
2/18
|
25.0%
2/8
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Gastrointestinal disorders
NAUSEA
|
12.5%
2/16
|
22.2%
4/18
|
12.5%
1/8
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Gastrointestinal disorders
VOMITING
|
6.2%
1/16
|
11.1%
2/18
|
0.00%
0/8
|
|
General disorders
ASTHENIA
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
General disorders
CHEST PAIN
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
General disorders
CHILLS
|
6.2%
1/16
|
22.2%
4/18
|
0.00%
0/8
|
|
General disorders
FATIGUE
|
50.0%
8/16
|
50.0%
9/18
|
62.5%
5/8
|
|
General disorders
FEELING JITTERY
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
6.2%
1/16
|
5.6%
1/18
|
12.5%
1/8
|
|
General disorders
INFUSION SITE ERYTHEMA
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
General disorders
INFUSION SITE IRRITATION
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
General disorders
INFUSION SITE PAIN
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
General disorders
INJECTION SITE EXTRAVASATION
|
6.2%
1/16
|
0.00%
0/18
|
12.5%
1/8
|
|
General disorders
INJECTION SITE PRURITUS
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
General disorders
MALAISE
|
6.2%
1/16
|
5.6%
1/18
|
12.5%
1/8
|
|
General disorders
OEDEMA PERIPHERAL
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
General disorders
PAIN
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
General disorders
PYREXIA
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
General disorders
THROMBOSIS IN DEVICE
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Infections and infestations
BRONCHITIS
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Infections and infestations
INFECTION
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Infections and infestations
INFLUENZA
|
6.2%
1/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.2%
1/16
|
11.1%
2/18
|
12.5%
1/8
|
|
Infections and infestations
ORCHITIS
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Infections and infestations
SINUSITIS
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
18.8%
3/16
|
16.7%
3/18
|
0.00%
0/8
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.5%
2/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Injury, poisoning and procedural complications
CITRATE TOXICITY
|
25.0%
4/16
|
11.1%
2/18
|
25.0%
2/8
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Nervous system disorders
RADICULITIS LUMBOSACRAL
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Nervous system disorders
SYNCOPE
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Nervous system disorders
TREMOR
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Pregnancy, puerperium and perinatal conditions
PERINEAL HAEMATOMA
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Psychiatric disorders
ANXIETY
|
6.2%
1/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Psychiatric disorders
DEPRESSION
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Psychiatric disorders
LIBIDO DECREASED
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Renal and urinary disorders
CALCULUS BLADDER
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Renal and urinary disorders
DYSURIA
|
6.2%
1/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Renal and urinary disorders
URINE ODOUR ABNORMAL
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Reproductive system and breast disorders
HAEMATOSPERMIA
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Reproductive system and breast disorders
PENILE PAIN
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Reproductive system and breast disorders
PERINEAL PAIN
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
12.5%
2/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
SNORING
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
HAIR GROWTH ABNORMAL
|
6.2%
1/16
|
0.00%
0/18
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Vascular disorders
FLUSHING
|
0.00%
0/16
|
5.6%
1/18
|
12.5%
1/8
|
|
Vascular disorders
HOT FLUSH
|
18.8%
3/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/16
|
11.1%
2/18
|
0.00%
0/8
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/16
|
0.00%
0/18
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.00%
0/16
|
5.6%
1/18
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the study will be coordinated by Dendreon in communication with institutions contributing patients to the study.
- Publication restrictions are in place
Restriction type: OTHER