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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
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Concurrent Arm Sequential Arm
Hide 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
Arm/Group Title Concurrent Arm Sequential Arm Total
Hide 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
Hide 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
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.
1.Primary Outcome
Title Cumulative CD54 Upregulation Ratio Between the Cohorts.
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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.
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
Hide 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%)    
Hide 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
Hide 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
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