Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

• Sponsor: Dendreon (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01431391
• Collaborator: (none)
• Enrollment: 68
• Locations: 14
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasm; Prostate Cancer; Prostatic Adenocarcinoma	Biological: sipuleucel-T; Drug: leuprolide acetate	Phase 2

Detailed Description

Multicenter, randomized, open-label study, with subjects allocated (1:1) to 1 of 2 study arms, using a stratified randomization based on:

• Prostate-specific antigen doubling time (PSADT): ≤ 3 months or > 3 months and ≤ 12 months. • Primary therapy: radical prostatectomy (RP) or radiation, including brachytherapy, (XRT) or RP + XRT.

Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.

Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.

Cellular and humoral immune responses were assessed for Arm 2 subjects at 12, 8, and 4 weeks pre infusion 1, and in all subjects (both arms) at pre-leukapheresis 1, 2, and 3, and post-infusion 1, 2 and 3, and at the following time points after the third infusion: Weeks 2, 6, and 12 and Months 6, 9, 12, 15, 18, 21, and 24.

Safety assessments included adverse event (AE) monitoring, laboratory tests (complete blood count (CBC) and serum chemistry), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, as well PSA and testosterone monitoring. The study was complete at the 27-Month visit for Arm 1 and the 24-Month visit for Arm 2.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Sipuleucel-T followed by ADT Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.	Biological: sipuleucel-T; Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).; Other Names: PROVENGE® APC8015 ; Drug: leuprolide acetate; 45.0 mg depot injection, 2 doses 6 months apart; Other Names: Eligard®
Experimental: Arm 2: ADT followed by sipuleucel-T Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.	Biological: sipuleucel-T; Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).; Other Names: PROVENGE® APC8015 ; Drug: leuprolide acetate; 45.0 mg depot injection, 2 doses 6 months apart; Other Names: Eligard®

Outcome Measures

Primary Outcome Measures

1. Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 [PA2024 ELISPOT counts at Month 24]

   Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.

Secondary Outcome Measures

1. Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024 [Month 24]

   A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hormone-sensitive prostate cancer

• Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis

• ECOG performance status ≤ 1

• Histologically documented prostate cancer

• Prior primary therapy for prostate cancer

• Rising PSA with a PSADT of ≤ 12 months

• Testosterone ≥ 200 ng/dL ≤ 28 days of registration

• Adequate hematologic, renal, and liver function

• Must live in a permanent residence within a comfortable driving distance (round-trip within one day) to the clinical research site

Exclusion Criteria:

• Requires systemic ongoing immunosuppressive therapy

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF

• Prior sipuleucel-T therapy

• Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total

• If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.

• Prior experimental immunotherapy or on an experimental clinical trial within 1 year

• Received denosumab or XRT ≤ 6 months prior to registration

• Received chemotherapy or GM-CSF ≤ 90 days prior to registration

• Received any of the following medications or interventions ≤ 28 days prior to registration

• major surgery requiring general anesthesia

• systemic immunosuppressive therapy

• other prescription treatment for prostate cancer

• Active infection within 1 week of registration

• Likely to receive XRT or surgery for prostate cancer during the study period

• Any medical intervention, any other condition, or any circumstances that could compromise the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Center of Alabama	Homewood	Alabama	United States	35209
2	University of California San Diego / Moores Cancer Center	La Jolla	California	United States	91914
3	Keck Hospital of USC	Los Angeles	California	United States	90033
4	LAC + USC Medical Center	Los Angeles	California	United States	90033
5	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
6	The Urology Center of Colorado	Denver	Colorado	United States	80211
7	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21287
8	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89169
9	NYOH Albany Cancer Center at Patroon Creek	Albany	New York	United States	12206
10	Community Care Physicians, PC	Albany	New York	United States	12208
11	Grand Strand Urology	Myrtle Beach	South Carolina	United States	29572
12	Urology San Antonio Research	San Antonio	Texas	United States	78229
13	Virginia Mason Medical Center	Seattle	Washington	United States	98101
14	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Dendreon

Investigators

• Study Director: Robert Israel, MD, Valeant Pharmaceuticals North America LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dendreon
• ClinicalTrials.gov Identifier: NCT01431391
• Other Study ID Numbers: P10-2
• First Posted: Sep 9, 2011
• Last Update Posted: May 30, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Dendreon: Immune therapy; Cancer vaccine; Therapeutic vaccine; Therapeutic cancer vaccine; Vaccine; Dendritic cells; PSA; Androgen deprivation therapy; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms; Prostatic Diseases; Androgens; Hormones; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Immunology; Hormone therapy; Immunotherapy; Luteinizing hormone-releasing hormone (LHRH)
• Additional relevant MeSH terms: Prostatic Neoplasms; Neoplasms; Adenocarcinoma; Leuprolide

Study Results

Participant Flow

Arm/Group Title	Arm 1:Sipuleucel-T Followed by ADT	Arm 2: ADT Followed by Sipuleucel-T
Arm/Group Description	Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.	Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
Period Title: Overall Study
STARTED	34	34
Received ≥1 Leaukapheresis	34	34
COMPLETED	26	30
NOT COMPLETED	8	4

Baseline Characteristics

Arm/Group Title	Arm 1: Sipuleucel-T Followed by ADT	Arm 2: ADT Followed by Sipuleucel-T	Total
Arm/Group Description	Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.	Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.	Total of all reporting groups
Overall Participants	34	34	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.4 (1.4)	66.2 (1.1)	65.8 (0.9)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	34 100%	34 100%	68 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	34 100%	34 100%	68 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	34 100%	34 100%	68 100%
Eastern Cooperative Oncology Group (ECOG) performance status (Count of Participants)
ECOG 0=Fully Active; No restrictions.	33 97.1%	34 100%	67 98.5%
ECOG 1= Restricted Strenuous Activity	1 2.9%	0 0%	1 1.5%
Gleason Score (Count of Participants)
Gleason Score ≤ 6	3 8.8%	4 11.8%	7 10.3%
Gleason Score = 7	23 67.6%	21 61.8%	44 64.7%
Gleason Score ≥ 8	8 23.5%	9 26.5%	17 25%

Outcome Measures

1. Primary Outcome

Title	Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
Description	Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.
Time Frame	PA2024 ELISPOT counts at Month 24

Outcome Measure Data

Analysis Population Description

The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.

Arm/Group Title	Arm 1: Sipuleucel-T Followed by ADT	Arm 2: ADT Followed by Sipuleucel-T
Arm/Group Description	Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.	Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
Measure Participants	19	26
Mean (Standard Error) [IFN-γ ELISPOT (per 300,000 PBMC)]	81.0 (28.0)	61.1 (23.7)

2. Secondary Outcome

Title	Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024
Description	A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description

The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.

Arm/Group Title	Arm 1:Sipuleucel-T Followed by ADT	Arm 2: ADT Followed by Sipuleucel-T
Arm/Group Description	Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.	Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
Measure Participants	33	34
Number [percentage of participants]	88 258.8%	85 250%

Adverse Events

Time Frame	All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal.
Adverse Event Reporting Description	Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Arm/Group Title	Arm 1: Sipuleucel-T Followed by ADT		Arm 2: ADT Followed by Sipuleucel-T
Arm/Group Description	Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.		Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
All Cause Mortality
	Arm 1: Sipuleucel-T Followed by ADT		Arm 2: ADT Followed by Sipuleucel-T
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: Sipuleucel-T Followed by ADT		Arm 2: ADT Followed by Sipuleucel-T
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/34 (2.9%)		5/34 (14.7%)
Cardiac disorders
Coronary artery disease	1/34 (2.9%)	1	0/34 (0%)	0
Angina pectoris	0/34 (0%)	0	1/34 (2.9%)	1
Coronary artery occlusion	0/34 (0%)	0	1/34 (2.9%)	1
Ear and labyrinth disorders
Vertigo	0/34 (0%)	0	1/34 (2.9%)	1
General disorders
Chest pain	0/34 (0%)	0	1/34 (2.9%)	1
Infections and infestations
Device-related sepsis	0/34 (0%)	0	1/34 (2.9%)	1
Injury, poisoning and procedural complications
Post-procedural hemorrhage	0/34 (0%)	0	1/34 (2.9%)	1
Nervous system disorders
Syncope	0/34 (0%)	0	1/34 (2.9%)	1
Transient ischaemic attack	0/34 (0%)	0	1/34 (2.9%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/34 (0%)	0	1/34 (2.9%)	1
Other (Not Including Serious) Adverse Events
	Arm 1: Sipuleucel-T Followed by ADT		Arm 2: ADT Followed by Sipuleucel-T
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/34 (97.1%)		34/34 (100%)
Cardiac disorders
Bradycardia	1/34 (2.9%)	1	3/34 (8.8%)	3
Coronary artery disease	0/34 (0%)	0	2/34 (5.9%)	2
Gastrointestinal disorders
Paraesthesia oral	5/34 (14.7%)	9	6/34 (17.6%)	10
Nausea	5/34 (14.7%)	6	3/34 (8.8%)	3
Vomiting	2/34 (5.9%)	3	2/34 (5.9%)	2
Diarrhoea	0/34 (0%)	0	3/34 (8.8%)	4
Food poisoning	2/34 (5.9%)	2	1/34 (2.9%)	1
Constipation	2/34 (5.9%)	2	1/34 (2.9%)	1
General disorders
Fatigue	13/34 (38.2%)	19	21/34 (61.8%)	26
Chills	9/34 (26.5%)	19	6/34 (17.6%)	8
Oedema peripheral	3/34 (8.8%)	3	4/34 (11.8%)	4
Pyrexia	3/34 (8.8%)	5	3/34 (8.8%)	3
Pain	2/34 (5.9%)	2	3/34 (8.8%)	3
Influenza-like illness	0/34 (0%)	0	3/34 (8.8%)	4
Injection-site extravasation	1/34 (2.9%)	1	2/34 (5.9%)	2
Injection-site haematoma	1/34 (2.9%)	1	2/34 (5.9%)	3
Asthenia	2/34 (5.9%)	2	5/34 (14.7%)	6
Injection site pain	0/34 (0%)	0	2/34 (5.9%)	2
Infections and infestations
Cystitis	1/34 (2.9%)	1	2/34 (5.9%)	2
Sinusitis	0/34 (0%)	0	2/34 (5.9%)	2
Injury, poisoning and procedural complications
Citrate toxicity	6/34 (17.6%)	12	6/34 (17.6%)	13
Contusion	5/34 (14.7%)	6	3/34 (8.8%)	4
Fall	3/34 (8.8%)	6	0/34 (0%)	0
Infusion-related reaction	2/34 (5.9%)	3	1/34 (2.9%)	1
Investigations
Weight increased	4/34 (11.8%)	4	4/34 (11.8%)	4
Blood pressure increased	0/34 (0%)	0	2/34 (5.9%)	2
Neutrophil count decreased	0/34 (0%)	0	2/34 (5.9%)	2
Metabolism and nutrition disorders
Dehydration	0/34 (0%)	0	3/34 (8.8%)	4
Hyperlipidaemia	0/34 (0%)	0	2/34 (5.9%)	2
Obesity	0/34 (0%)	0	2/34 (5.9%)	2
Musculoskeletal and connective tissue disorders
Pain in extremity	7/34 (20.6%)	8	4/34 (11.8%)	4
Back pain	3/34 (8.8%)	3	5/34 (14.7%)	6
Muscle spasms	4/34 (11.8%)	5	2/34 (5.9%)	2
Muscular weakness	1/34 (2.9%)	1	4/34 (11.8%)	4
Neck pain	2/34 (5.9%)	2	0/34 (0%)	0
Arthralgia	4/34 (11.8%)	5	6/34 (17.6%)	7
Nervous system disorders
Headache	9/34 (26.5%)	10	7/34 (20.6%)	7
Hypoaesthesia	2/34 (5.9%)	2	0/34 (0%)	0
Tremor	0/34 (0%)	0	2/34 (5.9%)	4
Dizziness	5/34 (14.7%)	5	4/34 (11.8%)	4
Paraesthesia	5/34 (14.7%)	5	4/34 (11.8%)	4
Psychiatric disorders
Anxiety	3/34 (8.8%)	3	4/34 (11.8%)	4
Depression	1/34 (2.9%)	1	2/34 (5.9%)	2
Loss of libido	0/34 (0%)	0	2/34 (5.9%)	2
Libido decreased	2/34 (5.9%)	2	0/34 (0%)	0
Insomnia	4/34 (11.8%)	4	5/34 (14.7%)	5
Renal and urinary disorders
Haematuria	1/34 (2.9%)	1	6/34 (17.6%)	7
Pollakiuria	3/34 (8.8%)	3	3/34 (8.8%)	3
Urinary incontinence	3/34 (8.8%)	3	1/34 (2.9%)	1
Micturation urgency	2/34 (5.9%)	2	1/34 (2.9%)	1
Nocturia	1/34 (2.9%)	1	2/34 (5.9%)	2
Dysuria	0/34 (0%)	0	2/34 (5.9%)	2
Incontinence	0/34 (0%)	0	2/34 (5.9%)	2
Urinary retention	2/34 (5.9%)	3	0/34 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/34 (2.9%)	1	3/34 (8.8%)	4
Cough	2/34 (5.9%)	2	1/34 (2.9%)	1
Oropharyngeal pain	0/34 (0%)	0	2/34 (5.9%)	2
Skin and subcutaneous tissue disorders
Rash	3/34 (8.8%)	5	2/34 (5.9%)	3
Pruritus	1/34 (2.9%)	2	3/34 (8.8%)	3
Erythema	2/34 (5.9%)	2	1/34 (2.9%)	1
Vascular disorders
Hot flush	19/34 (55.9%)	20	23/34 (67.6%)	23
Hypertension	3/34 (8.8%)	3	5/34 (14.7%)	5
Haematoma	3/34 (8.8%)	4	3/34 (8.8%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.