Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01487863

Recruitment Status : Completed

First Posted : December 8, 2011

Results First Posted : June 12, 2017

Last Update Posted : March 19, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Dendreon

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
Conditions	Prostate Cancer Metastatic Hormone Refractory Prostate Cancer Castration-resistant Prostate Cancer
Interventions	Biological: sipuleucel-T Drug: abiraterone acetate
Enrollment	69

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Concurrent Arm	Sequential Arm
Arm/Group Description	Subjects received sipuleucel-T with...	Subjects received sipuleucel-T ther...
Arm/Group Description	Subjects received sipuleucel-T with concurrent abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.	Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.
Period Title: Overall Study
Started	35	34
Subjects Randomized (Efficacy Analysis)	35	34
Rcvd ≥1 Leukapheresis (Safety Analysis)	35	34
Completed	16	15
Not Completed	19	19
Reason Not Completed
Death	19	19

Baseline Characteristics

Arm/Group Title		Concurrent Arm	Sequential Arm	Total
Arm/Group Description		Subjects received sipuleucel-T conc...	Subjects received sipuleucel-T ther...	Total of all reporting groups
Arm/Group Description		Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.	Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		35	34	69
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	35 participants	34 participants	69 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	13 37.1%	11 32.4%	24 34.8%
	>=65 years	22 62.9%	23 67.6%	45 65.2%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	35 participants	34 participants	69 participants
		69.7 (9.8)	70.5 (10.15)	70.1 (9.91)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	35 participants	34 participants	69 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	35 100.0%	34 100.0%	69 100.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	35 participants	34 participants	69 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	2 5.9%	2 2.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 5.7%	3 8.8%	5 7.2%
	White	33 94.3%	29 85.3%	62 89.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	35 participants	34 participants	69 participants
United States		35	34	69
Weight Mean (Standard Deviation) Unit of measure: Kg
	Number Analyzed	35 participants	34 participants	69 participants
		94.22 (21.38)	93.46 (16.29)	93.85 (18.90)
Height Mean (Standard Deviation) Unit of measure: Centimeters
	Number Analyzed	35 participants	34 participants	69 participants
		176.10 (8.25)	177.39 (8.06)	176.73 (8.12)
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	35 participants	34 participants	69 participants
ECOG 0=Fully Active; No restrictions		28 80.0%	26 76.5%	54 78.3%
ECOG 1= Restricted Strenuous Activity		7 20.0%	8 23.5%	15 21.7%
		[1] Measure Description: 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
Gleason Score ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	35 participants	34 participants	69 participants
Gleason Score ≤ 6		5 14.3%	5 14.7%	10 14.5%
Gleason Score = 7		12 34.3%	8 23.5%	20 29.0%
Gleason Score ≥ 8		18 51.4%	20 58.8%	38 55.1%
Gleason Score - Missing Data		0 0.0%	1 2.9%	1 1.4%
		[1] Measure Description: 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.

Outcome Measures

1.Primary Outcome


Title	Cumulative CD54 Upregulation Ratio Between the Cohorts.
Description	An analysis of variance model for the log transformed cumulative CD54 ...
Description	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.
Time Frame	Over the course of sipuleucel-T therapy (approximately 1 month)

Outcome Measure Data

Analysis Population Description

The efficacy population is defined as all randomized subjects. All the subjects in the efficacy population were analyzed according to the treatment that they were randomized to receive.


Arm/Group Title	Concurrent Arm	Sequential Arm
Arm/Group Description:	Subjects received sipuleucel-T conc...	Subjects received sipuleucel-T ther...
Arm/Group Description:	Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.	Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.
Overall Number of Participants Analyzed	35	34
Mean (Standard Error) Unit of Measure: Ratio ofCD54 molecules on BDS65:FP cells
	36.72 (2.32)	41.61 (2.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Concurrent Arm, Sequential Arm
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2141
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon rank-sum test.

Adverse Events

Time Frame	All adverse events (AEs) and serious adverse events (SAEs) were recorded from registration until the Post-Treatment Visit (30-37 days after last study treatment). Only treatment-related AEs and cerebrovascular events (CVEs) ongoing at the Post-Treatment Visit, were followed until resolution, return to baseline or no further improvement was expected. After the Post-Treatment Visit, only new treatment-related SAEs and CVEs (regardless of causality) were collected and recorded as SAEs.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Concurrent Arm		Sequential Arm
Arm/Group Description	Subjects received sipuleucel-T conc...		Subjects received sipuleucel-T ther...
Arm/Group Description	Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.		Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.
All-Cause Mortality
	Concurrent Arm		Sequential Arm
	Affected / at Risk (%)		Affected / at Risk (%)
Total	19/35 (54.29%)		19/34 (55.88%)
Serious Adverse Events Serious Adverse Events
	Concurrent Arm		Sequential Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/35 (20.00%)		14/34 (41.18%)
Blood and lymphatic system disorders
Anaemia ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Cardiac disorders
Sinus tachycardia ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Gastrointestinal disorders
Diarrhoea ^* 1	1/35 (2.86%)	1	0/34 (0.00%)	0
Rectal Haemorrhage ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
General disorders
Disease Progression ^* 1	1/35 (2.86%)	1	2/34 (5.88%)	2
Asthenia ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Chest Pain ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Systemic Inflammatory Response Syndrome ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Infections and infestations
Cystitis ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Influenza ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Sepsis ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Urosepsis ^* 1	1/35 (2.86%)	1	0/34 (0.00%)	0
Injury, poisoning and procedural complications
Subdural Haematoma ^* 1	1/35 (2.86%)	1	0/34 (0.00%)	0
Metabolism and nutrition disorders
Dehydration ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Hypokalaemia ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Pathological Fracture ^* 1	1/35 (2.86%)	1	0/34 (0.00%)	0
Nervous system disorders
Syncope ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Cerebrovascular Accident ^* 1	1/35 (2.86%)	1	0/34 (0.00%)	0
Haemorrhage Intracranial ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Renal and urinary disorders
Haematuria ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Obstructive Uropathy ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Renal Failure ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Ureteric Obstruction ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism ^* 1	1/35 (2.86%)	1	0/34 (0.00%)	0
Respiratory Distress ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
Vascular disorders
Hypertensive Crisis ^* 1	0/35 (0.00%)	0	1/34 (2.94%)	1
1 Term from vocabulary, MedDRA 14.1 * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Concurrent Arm		Sequential Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/35 (100.00%)		32/34 (94.12%)
Blood and lymphatic system disorders
Anaemia ^* 1	2/35 (5.71%)	2	7/34 (20.59%)	12
Ear and labyrinth disorders
Vertigo ^* 1	2/35 (5.71%)	2	1/34 (2.94%)	1
Gastrointestinal disorders
Nausea ^* 1	8/35 (22.86%)	9	10/34 (29.41%)	12
Paraesthesia Oral ^* 1	8/35 (22.86%)	12	7/34 (20.59%)	14
Constipation ^* 1	4/35 (11.43%)	4	7/34 (20.59%)	8
Diarrhoea ^* 1	6/35 (17.14%)	7	3/34 (8.82%)	5
Vomiting ^* 1	3/35 (8.57%)	3	5/34 (14.71%)	6
Abdominal Pain ^* 1	2/35 (5.71%)	2	3/34 (8.82%)	3
Dyspepsia ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	4
Flatulence ^* 1	2/35 (5.71%)	2	1/34 (2.94%)	1
Abdominal Distension ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
General disorders
Fatigue ^* 1	10/35 (28.57%)	10	9/34 (26.47%)	17
Oedema Periperal ^* 1	10/35 (28.57%)	12	5/34 (14.71%)	6
Chills ^* 1	6/35 (17.14%)	9	8/34 (23.53%)	12
Pyrexia ^* 1	7/35 (20.00%)	7	5/34 (14.71%)	8
Pain ^* 1	1/35 (2.86%)	1	7/34 (20.59%)	8
Influenza Like Illness ^* 1	1/35 (2.86%)	1	5/34 (14.71%)	8
Asthenia ^* 1	3/35 (8.57%)	3	2/34 (5.88%)	2
Gait Disturbance ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	3
Chest Pain ^* 1	0/35 (0.00%)	0	3/34 (8.82%)	4
Oedema ^* 1	2/35 (5.71%)	2	0/34 (0.00%)	0
Infections and infestations
Nasopharyngitis ^* 1	2/35 (5.71%)	2	2/34 (5.88%)	3
Urinary Tract Infection ^* 1	3/35 (8.57%)	3	1/34 (2.94%)	1
Bronchitis ^* 1	1/35 (2.86%)	1	2/34 (5.88%)	2
Influenza ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Oral Herpes ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Injury, poisoning and procedural complications
Citrate Toxicity ^* 1	3/35 (8.57%)	8	6/34 (17.65%)	12
Contusion ^* 1	3/35 (8.57%)	3	2/34 (5.88%)	3
Fall ^* 1	1/35 (2.86%)	1	4/34 (11.76%)	4
Procedural Pain ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Investigations
Blood Alkaline Phosphatase Increased ^* 1	0/35 (0.00%)	0	3/34 (8.82%)	3
Blood Urea Increased ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Heart Rate Irregular ^* 1	2/35 (5.71%)	2	0/34 (0.00%)	0
Weight Decreased ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Metabolism and nutrition disorders
Decreased Appetite ^* 1	1/35 (2.86%)	1	4/34 (11.76%)	4
Dehydration ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	3
Hypokalaemia ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	3
Hyperglycaemia ^* 1	3/35 (8.57%)	3	0/34 (0.00%)	0
Hyponatraemia ^* 1	2/35 (5.71%)	2	0/34 (0.00%)	0
Musculoskeletal and connective tissue disorders
Muscle spasms ^* 1	17/35 (48.57%)	22	9/34 (26.47%)	14
Back Pain ^* 1	6/35 (17.14%)	6	10/34 (29.41%)	10
Arthralgia ^* 1	6/35 (17.14%)	7	7/34 (20.59%)	9
Pain in Extremity ^* 1	3/35 (8.57%)	3	8/34 (23.53%)	11
Musculoskeletal Chest Pain ^* 1	4/35 (11.43%)	5	3/34 (8.82%)	3
Musculoskeletal Pain ^* 1	4/35 (11.43%)	6	2/34 (5.88%)	5
Myalgia ^* 1	3/35 (8.57%)	5	3/34 (8.82%)	5
Bone Pain ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	3
Muscular Weakness ^* 1	2/35 (5.71%)	2	1/34 (2.94%)	1
Flank Pain ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Nervous system disorders
Paraesthesia ^* 1	5/35 (14.29%)	6	6/34 (17.65%)	8
Headache ^* 1	5/35 (14.29%)	5	5/34 (14.71%)	6
Dizziness ^* 1	2/35 (5.71%)	2	6/34 (17.65%)	9
Hypoaesthesia ^* 1	2/35 (5.71%)	2	4/34 (11.76%)	4
Tremor ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	3
Dysgeusia ^* 1	1/35 (2.86%)	1	2/34 (5.88%)	3
Syncope ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	3
Psychiatric disorders
Anxiety ^* 1	3/35 (8.57%)	3	1/34 (2.94%)	1
Insomnia ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	3
Depression ^* 1	0/35 (0.00%)	0	3/34 (8.82%)	4
Renal and urinary disorders
Pollakiuria ^* 1	2/35 (5.71%)	2	3/34 (8.82%)	3
Haematuria ^* 1	1/35 (2.86%)	1	2/34 (5.88%)	2
Dysuria ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Hydronephrosis ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	3
Reproductive system and breast disorders
Gynaecomastia ^* 1	2/35 (5.71%)	2	2/34 (5.88%)	2
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	9/35 (25.71%)	10	7/34 (20.59%)	10
Dyspnoea ^* 1	3/35 (8.57%)	3	5/34 (14.71%)	7
Nasal Congestion ^* 1	2/35 (5.71%)	2	2/34 (5.88%)	2
Epistaxis ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Hypoxia ^* 1	0/35 (0.00%)	0	2/34 (5.88%)	2
Pleuritic Pain ^* 1	2/35 (5.71%)	2	0/34 (0.00%)	0
Skin and subcutaneous tissue disorders
Ecchymosis ^* 1	4/35 (11.43%)	6	4/34 (11.76%)	5
Hyperhidrosis ^* 1	1/35 (2.86%)	1	3/34 (8.82%)	3
Vascular disorders
Hot Flush ^* 1	5/35 (14.29%)	5	3/34 (8.82%)	3
Hypertension ^* 1	4/35 (11.43%)	4	4/34 (11.76%)	4
1 Term from vocabulary, MedDRA 14.1 * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Shabnam Vaziri
Organization:	Dendreon
Phone:	206-455-2323
EMail:	svaziri@Dendreon.com

Layout table for additonal information

Responsible Party:	Dendreon
ClinicalTrials.gov Identifier:	NCT01487863
Other Study ID Numbers:	P11-3
First Submitted:	December 6, 2011
First Posted:	December 8, 2011
Results First Submitted:	March 27, 2017
Results First Posted:	June 12, 2017
Last Update Posted:	March 19, 2019

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