PROCEED: A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

• Sponsor: Dendreon (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01306890
• Collaborator: (none)
• Enrollment: 1,976
• Locations: 333
• Actual Duration (Months): 71.7
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.

Condition or Disease	Intervention/Treatment	Phase
Advanced Prostate Cancer; Prostatic Neoplasms	Biological: sipuleucel-T

Detailed Description

Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.

Study Design

• Study Type: Observational
• Actual Enrollment: 1976 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
• Actual Study Start Date: Jan 27, 2011
• Actual Primary Completion Date: Jan 17, 2017
• Actual Study Completion Date: Jan 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
sipuleucel-T	Biological: sipuleucel-T; Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.; Other Names: PROVENGE, APC8015

Outcome Measures

Primary Outcome Measures

1. To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects [Every 3 months for a minimum of 3 years]

   The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.

Secondary Outcome Measures

1. Survival [Every 3 months for a minimum of 3 years]

   To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• subjects must be at least 18 years of age

• subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment

• subjects must understand and sign an informed consent form

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Hematology and Oncology Associates, LLC	Bessemer	Alabama	United States	35022
2	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama	United States	35205
3	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama	United States	35211
4	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama	United States	35213
5	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama	United States	35235
6	Clearview Cancer Institute	Huntsville	Alabama	United States	35805
7	Ironwood Cancer and Research	Chandler	Arizona	United States	85224-5665
8	Palo Verde Cancer Specialists	Glendale	Arizona	United States	85304
9	Weatern Regional Medical Center / Cancer Treatment Centers of America	Goodyear	Arizona	United States	85338
10	21st Century Oncology	Scottsdale	Arizona	United States	85251
11	Pinnacle Oncology Hematology, Oncology Research Associates, PLLC	Scottsdale	Arizona	United States	85258
12	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona	United States	85704
13	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona	United States	85710
14	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona	United States	85712
15	El Dorado Research	Tucson	Arizona	United States	85715
16	Urological Associates of Southern Arizona, P.C.	Tucson	Arizona	United States	85715
17	Little Rock Hematology Oncology: A Division of CARTI	Little Rock	Arkansas	United States	72205
18	South County Hematology/Oncology	Chula Vista	California	United States	91911
19	Wilshire Oncology Medical Group, Inc.	Corona	California	United States	92879
20	Urology Specialists of Southern California	Encino	California	United States	91436-2140
21	Robert A. Moss, M.D., F.A.C.P., Inc	Fountain Valley	California	United States	92708
22	Pacific Shores Medical Group	Glendale	California	United States	91204
23	Wilshire Oncology Medical Group, Inc.	Glendora	California	United States	91741
24	Pacific Shores Medical Group	Huntington Beach	California	United States	92648
25	UCSD Medical Center - La Jolla	La Jolla	California	United States	92037
26	UCSD Moores Cancer Center	La Jolla	California	United States	92093-0820
27	Moores UCSD Cancer Center	La Jolla	California	United States	92093
28	Cancer Center Oncology Medical Group	La Mesa	California	United States	91942
29	Wilshire Oncology Medical Group, Inc.	La Verne	California	United States	91750
30	Pacific Shores Medical Group	Long Beach	California	United States	90813
31	Pacific Shores Medical Group	Los Alamitos	California	United States	90720
32	UCLA Institute of Urologic Oncology, UCLA Medical Center	Los Angeles	California	United States	90024
33	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
34	Tower Urology	Los Angeles	California	United States	90048
35	Prostate Oncology Speciality Inc.	Marina Del Rey	California	United States	90292
36	Tri Valley Urology Medical Group	Murrieta	California	United States	92562
37	North County Oncology Medical Group, Inc.	Oceanside	California	United States	92056
38	Hematology-Oncology Medical Group of Orange County, Inc.	Orange	California	United States	92868
39	Medical Oncology Care Associates (MOCA)	Orange	California	United States	92868
40	The Center for Cancer Prevention and Treatment, St. Joseph Hospital	Orange	California	United States	92868
41	PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists	Oxnard	California	United States	93030
42	Wilshire Oncology Medical Group, Inc.	Pasadena	California	United States	91105
43	Wilshire Oncology Medical Group, Inc.	Pomona	California	United States	91767
44	Wilshire Oncology Medical Group, Inc.	Rancho Cucamonga	California	United States	91730
45	Sutter Roseville Medical Center	Roseville	California	United States	95677
46	Sutter Cancer Center / Sacramento Center for Hematology and Medical Oncology	Sacramento	California	United States	95816
47	Sutter Memorial Hospital	Sacramento	California	United States	95819-3223
48	UCSD Medical Center - Hillcrest	San Diego	California	United States	92103
49	Genesis Research	San Diego	California	United States	92123
50	Medical Oncology Associates	San Diego	California	United States	92123
51	Sharp Clinical Oncology Research	San Diego	California	United States	92123
52	Sharp Rees-Stealy	San Diego	California	United States	92123
53	Edward Alexson, MD, Inc.	Santa Ana	California	United States	92705
54	Stockton Hematology Oncology Medical Group	Stockton	California	United States	95204
55	Contra Costa Oncology	Walnut Creek	California	United States	94598
56	Wilshire Oncology Medical Group, Inc.	West Covina	California	United States	91790
57	Rocky Mountain Cancer Centers	Aurora	Colorado	United States	80012
58	Rocky Mountain Cancer Centers	Boulder	Colorado	United States	80303
59	Rocky Mountain Cancer Centers	Colorado Springs	Colorado	United States	80907
60	Rocky Mountain Cancer Centers	Colorado Springs	Colorado	United States	80909
61	The Urology Center of Colorado	Denver	Colorado	United States	80211
62	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80218
63	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80220
64	Western Oncology/Hematology Associates, PC	Golden	Colorado	United States	80401
65	Rocky Mountain Cancer Centers	Lakewood	Colorado	United States	80228
66	Rocky Mountain Cancer Centers	Littleton	Colorado	United States	80120-4413
67	Rocky Mountain Cancer Centers	Lone Tree	Colorado	United States	80124
68	Rocky Mountain Cancer Centers	Longmont	Colorado	United States	80501
69	Advanced Urology, PC	Parker	Colorado	United States	80134
70	Rocky Mountain Cancer Centers	Parker	Colorado	United States	80138
71	Rocky Mountain Cancer Centers	Pueblo	Colorado	United States	81008
72	Rocky Mountain Cancer Centers	Thornton	Colorado	United States	80260
73	Grove Hill Clinical Research, Grove Hill Medical Center, Urology Center of Grove Hill	New Britain	Connecticut	United States	06052
74	Yale Urology	New Haven	Connecticut	United States	06511
75	Norwalk Hospital	Norwalk	Connecticut	United States	06856
76	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut	United States	06360
77	The Stamford Hospital	Stamford	Connecticut	United States	06902
78	Georgetown University Hospital	Washington	District of Columbia	United States	20007
79	Howard University Cancer Center & Howeard University Hospital	Washington	District of Columbia	United States	20060
80	Mount Sinai Comprehensive Cancer Center	Aventura	Florida	United States	33180
81	Manatee Medical Research Institute, LLC	Bradenton	Florida	United States	34205
82	21st Century Oncology	Crestview	Florida	United States	32539
83	Integrated Community Oncology Network	Fleming Island	Florida	United States	32003
84	21st Century Oncology	Fort Myers	Florida	United States	33907
85	Florida Cancer Specialists, PL	Hudson	Florida	United States	34667
86	Integrated Community Oncology Network	Jacksonville Beach	Florida	United States	32250
87	Integrated Community Oncology Network	Jacksonville	Florida	United States	32204
88	Integrated Community Oncology Network	Jacksonville	Florida	United States	32207
89	Cancer Specialists of North Florida	Jacksonville	Florida	United States	32256
90	Integrated Community Oncology Network	Jacksonville	Florida	United States	32258
91	Watson Clinic LLP, Center for Cancer Care & Research, Clark & Daughtrey Medical Group, PA	Lakeland	Florida	United States	33805
92	Northwest Florida Hematology Oncology PA	Lynn Haven	Florida	United States	32444
93	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida	United States	33140
94	Advanced Medical Specialties	Miami	Florida	United States	33143
95	Advanced Medical Specialties	Miami	Florida	United States	33176
96	21st Century Oncology	Naples	Florida	United States	34102
97	Premier Oncology	Naples	Florida	United States	34102
98	Florida Cancer Specialists, PL	New Port Richey	Florida	United States	34655
99	Ocala Oncology Center	Ocala	Florida	United States	33471
100	Atlantic Urological Associates	Orange City	Florida	United States	32763
101	Integrated Community Oncology Network	Orange Park	Florida	United States	32073
102	Integrated Community Oncology Network	Palatka	Florida	United States	32177
103	Sacred Heart Medical Oncology Groupl	Pensacola	Florida	United States	32504
104	Integrated Community Oncology Network	Saint Augustine	Florida	United States	32086
105	Southeastern Research Group, Inc.	Tallahassee	Florida	United States	32308
106	Georgia Cancer Specialists - Alpharetta	Alpharetta	Georgia	United States	30005
107	Georgia Cancer Specialists - Athens	Athens	Georgia	United States	30606
108	Georgia Cancer Specialists - Emory Midtown	Atlanta	Georgia	United States	30308
109	Midtown Urology	Atlanta	Georgia	United States	30308
110	Atlanta Hematology Oncology Associates	Atlanta	Georgia	United States	30309-1710
111	Peachtree Hematology-Oncology Consultants, PC	Atlanta	Georgia	United States	30318
112	Piedmont West	Atlanta	Georgia	United States	30318
113	Emory University Hospital, The Emory Clinic, Winship Cancer Institute	Atlanta	Georgia	United States	30322
114	Georgia Urology, PA	Atlanta	Georgia	United States	30342
115	Augusta Oncology Associates, PC	Augusta	Georgia	United States	30901
116	Northwest Georgia Oncology Centers, P.C.	Austell	Georgia	United States	30106
117	Northwest Georgia Oncology Centers, P.C.	Carrollton	Georgia	United States	30117
118	Northwest Georgia Oncology Centers, P.C.	Cartersville	Georgia	United States	30121
119	John B. Amos Cancer Center	Columbus	Georgia	United States	31904
120	Georgia Cancer Specialists - Stemmer	Decatur	Georgia	United States	30033
121	Northwest Georgia Oncology Centers, P.C.	Douglasville	Georgia	United States	30134
122	Gwinnett Hospital System Inc. dba Center for Cancer Care	Duluth	Georgia	United States	30096
123	Georgia Cancer Specialists - Fayetteville	Fayetteville	Georgia	United States	30215
124	Gwinnett Hospital System Inc. dba Center for Cancer Care	Lawrenceville	Georgia	United States	30046
125	Georgia Cancer Specialists - Macon	Macon	Georgia	United States	31217
126	Georgia Cancer Specialists - Kennestone	Marietta	Georgia	United States	30060
127	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia	United States	30060
128	Urology Enterprises	Marietta	Georgia	United States	30060
129	Harbin Clinic	Rome	Georgia	United States	30165
130	Georgia Cancer Specialists - Northside	Sandy Springs	Georgia	United States	30342
131	Gwinnett Hospital System Inc. dba Center for Cancer Care	Snellville	Georgia	United States	30078
132	Georgia Cancer Specialists - Stockbridge	Stockbridge	Georgia	United States	30281
133	Joliet Oncology-Hematology Associates, Ltd.	Joliet	Illinois	United States	60435
134	Urological Surgeons of Illinois	Kankakee	Illinois	United States	60901
135	Oncology Specialists, S.C.	Niles	Illinois	United States	60714
136	Mid-Illinois Hematology & Oncology Associates, LTD	Normal	Illinois	United States	61761
137	Oncology Specialists, S.C.	Park Ridge	Illinois	United States	60068
138	Midwestern Regional Medical Center	Zion	Illinois	United States	60099
139	Elkhart Clinic	Elkhart	Indiana	United States	46514
140	Elkhart General Hospital	Elkhart	Indiana	United States	46514
141	Urological Associates, Inc.	Evansville	Indiana	United States	47714
142	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46845
143	Metropolitan Urology Clinical Research	Jeffersonville	Indiana	United States	47130
144	Indiana University Health La Porte Hospital	LaPorte	Indiana	United States	46350
145	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545
146	Michiana Hematology Oncology, P. C.	Plymouth	Indiana	United States	46563
147	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
148	Northern Indiana Cancer Research Consortium, Michiana Hematology Oncology, P.C.	South Bend	Indiana	United States	46601
149	Michiana Hematology Oncology, P. C.	Westville	Indiana	United States	46391
150	McFarland Clinic, PC	Ames	Iowa	United States	50010
151	Physician's Clinic of Iowa, P.C.	Cedar Rapids	Iowa	United States	52401
152	Heartland Oncology & Hematology, PLLC	Council Bluffs	Iowa	United States	51503
153	Kansas City Urology Care	Overland Park	Kansas	United States	66211
154	University of Kansas Cancer Center	Westwood	Kansas	United States	66205
155	Cancer Center of Kansas	Wichita	Kansas	United States	67214
156	Wichita Urology Group P.A	Wichita	Kansas	United States	67226
157	Jewish Hospital & St. Mary's Healthcare	Louisville	Kentucky	United States	40245
158	Louisiana Oncology Associates	Crowley	Louisiana	United States	70526
159	Louisiana Oncology Associates	Lafayette	Louisiana	United States	70508
160	Louisiana Oncology Associates	New Iberia	Louisiana	United States	70560
161	Tulane University Health Sciences Center	New Orleans	Louisiana	United States	70112
162	Louisiana Oncology Associates	Opelousas	Louisiana	United States	70570
163	Northwest Louisiana Oncology Associates Of Highland Clinic	Shreveport	Louisiana	United States	71105
164	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
165	Chesapeake Urology Research Associates	Baltimore	Maryland	United States	21204
166	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889
167	Myron I Murdock MD LLC	Greenbelt	Maryland	United States	20770
168	MedStar Montgomery Medical Center	Olney	Maryland	United States	20832
169	Tufts Medical Center	Boston	Massachusetts	United States	02111
170	Steward Sr. Elizabeth's Medical Center of Boston Inc.	Boston	Massachusetts	United States	02135
171	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
172	Henry Ford Medical Center - Woodhaven	Brownstown	Michigan	United States	48183
173	Henry Ford Medical Center - Fairlane	Dearborn	Michigan	United States	48126
174	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
175	Henry Ford Hospital	Detroit	Michigan	United States	48202
176	Karmanos Cancer Institute at Farmington Hills	Farmington Hills	Michigan	United States	48334
177	Lakeland Hospital	Niles	Michigan	United States	49120
178	Henry Ford Medical Center - Columbus Center	Novi	Michigan	United States	48377
179	Michgan Institute of Urology, PC	Saint Clair Shores	Michigan	United States	48081
180	Lakeland Hospital	Saint Joseph	Michigan	United States	49085-2158
181	Marie Yeager Cancer Center	Saint Joseph	Michigan	United States	49085
182	Michigan Institute of Urology, PC	Troy	Michigan	United States	48084
183	Michigan Institute of Urology, PC	Utica	Michigan	United States	48317
184	Henry Ford Medical Center- West Bloomfield	West Bloomfield	Michigan	United States	48322
185	Minnesota Oncology Hematology, P.A.	Burnsville	Minnesota	United States	55337
186	Minnesota Oncology Hematology, P.A.	Coon Rapids	Minnesota	United States	55433
187	Minnesota Oncology Hematology, P.A.	Edina	Minnesota	United States	55435-2150
188	Minnesota Oncology Hematology, P.A.	Fridley	Minnesota	United States	55432
189	Minnesota Oncology Hematology, P.A.	Maplewood	Minnesota	United States	55109
190	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	United States	55404
191	University Of Minnesota	Minneapolis	Minnesota	United States	55455
192	Hubert H. Humphrey Cancer Center	Robbinsdale	Minnesota	United States	55422
193	Minnesota Oncology Hematology, P.A.	Saint Paul	Minnesota	United States	55102-2389
194	Adult and Pediatric Urology	Sartell	Minnesota	United States	56377
195	Minnesota Oncology Hematology, P.A.	Woodbury	Minnesota	United States	55125
196	The Jones Clinic, PC	New Albany	Mississippi	United States	38652
197	Family Cancer Center Foundation, Inc.	Oxford	Mississippi	United States	38655
198	Family Cancer Center Foundation, Inc.	Southaven	Mississippi	United States	38671
199	St. Louis Cancer Care, LLP	Bridgeton	Missouri	United States	63044
200	St. Louis Cancer Care, LLP	Chesterfield	Missouri	United States	63017
201	Ellis Fischel Cancer Center - University of Missouri Health Care	Columbia	Missouri	United States	65203
202	Saint Luke's Cancer Institute, Saint Luke's Hospital	Kansas City	Missouri	United States	64111
203	St. Louis Cancer Care, LLP	Saint Louis	Missouri	United States	63127
204	Comprehensive Cancer Care	Saint Louis	Missouri	United States	63141
205	Nebraska Hematology-Oncology, PC	Lincoln	Nebraska	United States	68506
206	Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center	Lincoln	Nebraska	United States	68510
207	Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center	Lincoln	Nebraska	United States	68516
208	Oncology Hematology West, PC dba Nebraska Cancer Specialists	Omaha	Nebraska	United States	68130
209	Urology Cancer Center & GU Research Network	Omaha	Nebraska	United States	68130
210	Comprehensive Cancer Centers of Nevada	Henderson	Nevada	United States	89014
211	Comprehensive Cancer Centers of Nevada	Henderson	Nevada	United States	89052
212	Comprehensive Cancer Centers of Nevada	Henderson	Nevada	United States	89074
213	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89128
214	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89148
215	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89169
216	Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756
217	New Jersey Urology, LLC	Bloomfield	New Jersey	United States	07003
218	Oncology and Hematology Specialists, P.A.	Denville	New Jersey	United States	07830
219	Hematology-Oncology Associates of Northern NJ, PA; Carol G. Simon Cancer Center	Morristown	New Jersey	United States	07962
220	Delaware Valley Urology, LLC	Mount Laurel	New Jersey	United States	08054
221	Sparta Cancer Center	Sparta	New Jersey	United States	07871
222	Urology Group of New Jersey	West Orange	New Jersey	United States	07052
223	New Mexico Oncology Hematology Consultants, LTD	Albuquerque	New Mexico	United States	87109
224	New Mexico Cancer Care Associates	Santa Fe	New Mexico	United States	87505
225	New York Oncology Hematology, P.C.	Albany	New York	United States	12206
226	New York Oncology Hematology, P.C.	Albany	New York	United States	12208
227	Albert Einstein Cancer Center at the Montefiore Medical Park	Bronx	New York	United States	10461
228	Montefiore Medical Center	Bronx	New York	United States	10467
229	Eastchester Center for Cancer Care	Bronx	New York	United States	10469
230	The Jonah Center	Buffalo	New York	United States	14215
231	Zale P. Bernstein, MD, PC	Buffalo	New York	United States	14215
232	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
233	North Shore Hematology/Oncology Associates	East Setauket	New York	United States	11733
234	Queens Medical Associates	Fresh Meadows	New York	United States	11366
235	NYU Clinical Cancer Center	New York	New York	United States	10016
236	NYU Langone Medical Center	New York	New York	United States	10016
237	Integrated Medical Professionals	North Hills	New York	United States	11042
238	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
239	James P. Wilmot Cancer Center	Rochester	New York	United States	14642
240	Staten Island Urological Research, PC	Staten Island	New York	United States	10304
241	Associated Medical Professionals of New York, PLLC	Syracuse	New York	United States	13210
242	Asheville Hematology & Oncology	Asheville	North Carolina	United States	28803
243	Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina	Cary	North Carolina	United States	27518
244	Presbyterian Hospital Cancer Center	Charlotte	North Carolina	United States	28204
245	Regional Cancer Care, P.A.	Durham	North Carolina	United States	27704
246	Duke University Medical Center - Duke South Clinics	Durham	North Carolina	United States	27710
247	Cape Fear Valley Health System	Fayetteville	North Carolina	United States	28304
248	Carolina Urology Partners	Gastonia	North Carolina	United States	28054-3456
249	Presbyterian Hospital Huntersville	Huntersville	North Carolina	United States	28078
250	Matthews Hematology Oncology Associates	Matthews	North Carolina	United States	28105
251	Presbyterian Hospital Matthews	Matthews	North Carolina	United States	28105
252	Lake Norman Hematology Oncology Specialists	Mooresville	North Carolina	United States	28117
253	Coastal Carolina Health Care, PA, dba New Bern Cancer Care	New Bern	North Carolina	United States	28562
254	Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina	Raleigh	North Carolina	United States	27607
255	Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina	Raleigh	North Carolina	United States	27614
256	TriState Urologic Services PSC, Inc. dba TUG Research	Cincinnati	Ohio	United States	45212
257	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210-1280
258	SouthWest Urology	Middleburg Heights	Ohio	United States	44130
259	Cancer Centers of Southwest Oklahoma	Altus	Oklahoma	United States	73521
260	Cancer Centers of Southwest Oklahoma	Duncan	Oklahoma	United States	73533
261	Cancer Centers of Southwest Oklahoma	Lawton	Oklahoma	United States	73505
262	Urologic Specialists of Oklahoma	Tulsa	Oklahoma	United States	74146
263	Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97213-2982
264	Providence Cancer Center Oncology and Hematology Care	Portland	Oregon	United States	97213
265	Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97225
266	Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97227
267	Oregon Urology Institute	Springfield	Oregon	United States	97477
268	Northwest Cancer Specialists, P.C.	Tualatin	Oregon	United States	97062
269	Urologic Consultants of SE PA	Bala-Cynwyd	Pennsylvania	United States	19004
270	Urology Health Specialists, LLC	Bryn Mawr	Pennsylvania	United States	19010
271	The Regional Cancer Center	Erie	Pennsylvania	United States	16505
272	Gettysburg Cancer Center	Gettysburg	Pennsylvania	United States	17325
273	Urological Associates of Lancaster	Lancaster	Pennsylvania	United States	17604
274	UPMC Cancer Center / Hillman Cancer Centerl	Pittsburgh	Pennsylvania	United States	15232
275	Scranton Hematology Oncology	Scranton	Pennsylvania	United States	18510
276	Cancer Care Associates of York	York	Pennsylvania	United States	17403
277	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina	United States	29414
278	South Carolina Oncology Associates, PA	Columbia	South Carolina	United States	29210
279	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
280	Urology Center of Spartanburg	Spartanburg	South Carolina	United States	29303
281	Lexington Oncology Associates, LLC	West Columbia	South Carolina	United States	29169
282	Avera Cancer Institute, Avera Medical Group Oncology and Hematology	Sioux Falls	South Dakota	United States	57105
283	Family Cancer Center Foundation, Inc.	Bartlett	Tennessee	United States	38133
284	The Jones Clinic, PC	Germantown	Tennessee	United States	38138
285	Family Cancer Center Foundation, Inc.	Memphis	Tennessee	United States	38119
286	Family Cancer Center Foundation, Inc.	Memphis	Tennessee	United States	38120
287	The West Clinic	Memphis	Tennessee	United States	38120
288	Tennessee Oncology, Centennial Medical Center	Nashville	Tennessee	United States	37203
289	Urology Associates, P.C.	Nashville	Tennessee	United States	37209
290	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
291	Hendrick Medical Center / Hendrick Cancer Center	Abilene	Texas	United States	79601
292	Texas Oncology-Abilene	Abilene	Texas	United States	79606-5208
293	Texas Oncology - Austin Midtown	Austin	Texas	United States	78705
294	Texas Oncolocy - South Austin	Austin	Texas	United States	78745
295	Texas Oncology - Austin North	Austin	Texas	United States	78758
296	Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center	Beaumont	Texas	United States	77702-1449
297	Texas Oncology - Cedar Park	Cedar Park	Texas	United States	78613
298	Cancer Specialists of South Texas, PA	Corpus Christi	Texas	United States	78412
299	Urology Clinics of North Texas, PLLC	Dallas	Texas	United States	75231-4482
300	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas	United States	75231
301	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas	United States	75246
302	Texas Oncology - Denton South	Denton	Texas	United States	76210
303	Texas Oncology - El Paso Cancer Treatment Center Grandview	El Paso	Texas	United States	79902
304	Texas Oncology - El Paso Cancer Treatment Center Gateway	El Paso	Texas	United States	79915
305	Texas Oncology - El Paso Cancer Treatment Center Joe Battle	El Paso	Texas	United States	79939
306	Texas Oncology - Fort Worth 12th Avenue	Fort Worth	Texas	United States	76104
307	Texas Oncology - Southwest Fort Worth	Fort Worth	Texas	United States	76132
308	UTHealth Oncology, Memorial Hermann Cancer Center	Houston	Texas	United States	77030
309	Memorial Hennann Hosptial - Southwest Cancer Center	Houston	Texas	United States	77074
310	Memorial Hennann Hospital - Northeast Cancer Center	Humble	Texas	United States	77338
311	Texas Oncology - Kyle	Kyle	Texas	United States	78640
312	Texas Oncology - Lewisville	Lewisville	Texas	United States	75067
313	Texas Oncology - Seton-Williamson	Round Rock	Texas	United States	78665
314	Texas Oncology - Round Rock	Round Rock	Texas	United States	78681
315	Urology San Antonio Research	San Antonio	Texas	United States	78229
316	Oncology San Antonio Research, LLC	San Antonio	Texas	United States	78240
317	Texas Oncology - San Marcos	San Marcos	Texas	United States	78666
318	Blood and Cancer Center of East Texas	Tyler	Texas	United States	75701
319	Texas Oncology - Deke Slayton Cancer Center	Webster	Texas	United States	77598-4420
320	Huntsman Cancer Hospital	Salt Lake City	Utah	United States	84112
321	Urology of Virginia / SMG	Norfolk	Virginia	United States	23502
322	Harrison Poulsbo Hematology & Oncology	Poulsbo	Washington	United States	98370
323	Virginia Mason Medical Center	Seattle	Washington	United States	98101
324	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
325	University of Washington	Seattle	Washington	United States	98109
326	Medical Oncology Associates, PS	Spokane	Washington	United States	99208
327	Northwest Cancer Specialists, P.C.	Vancouver	Washington	United States	98684
328	Northwest Cancer Specialists, P.C.	Vancouver	Washington	United States	98686
329	Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital	Brookfield	Wisconsin	United States	53045
330	Wheaton Franciscan Healthcare - Reiman Cancer Center	Franklin	Wisconsin	United States	53132
331	Wheaton Franciscan Healthcare - St. Joseph's Hospital	Milwaukee	Wisconsin	United States	53210
332	Wheaton Franciscan Healthcare - St. Francis Hospital	Milwaukee	Wisconsin	United States	53215
333	Wheaton Franciscan Healthcare -Wauwatosa Cancer Care	Wauwatosa	Wisconsin	United States	53226

Sponsors and Collaborators

• Dendreon

Investigators

• Study Director: Bruce Brown, MD, Dendreon Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dendreon
• ClinicalTrials.gov Identifier: NCT01306890
• Other Study ID Numbers: P10-3
• First Posted: Mar 2, 2011
• Last Update Posted: Jun 7, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Sipuleucel-T
Arm/Group Description	sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Period Title: Overall Study
STARTED	1976
COMPLETED	457
NOT COMPLETED	1519

Baseline Characteristics

Arm/Group Title	Sipuleucel-T
Arm/Group Description	sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Participants	1902
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	441 23.2%
>=65 years	1461 76.8%
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	71.9
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1902 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 0.3%
Asian	22 1.2%
Native Hawaiian or Other Pacific Islander	4 0.2%
Black or African American	221 11.6%
White	1649 86.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	1902 100%
Weight (kilogram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram]	91.97 (17.67)
Height (Centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeters]	176.59 (7.29)
Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants)
ECOG 0=Fully Active; No restrictions	1265 66.5%
ECOG 1= Restricted Strenuous Activity	571 30%
ECOG 2= Capable of selfcare	34 1.8%
ECOG 3= Capable of limited selfcare	8 0.4%
ECOG Not Reported	24 1.3%
Primary Gleason Score (Count of Participants)
Gleason Score ≤3	486 25.6%
Gleason Score ≥4	1145 60.2%
Primary Gleason Score Data Not Recorded	271 14.2%
Gleason Sum Reported (Count of Participants)
Gleason Score ≤7	790 41.5%
Gleason Score ≥8	963 50.6%
Gleson Sum Data Not Recorded	149 7.8%
Comorbidity Score (Count of Participants)
High	220 11.6%
Low	1682 88.4%
Alkaline phosphatase (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]	117.8 (163.2)
Hemoglobin (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]	12.68 (1.48)
Lactate dehydrogenase (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]	225.1 (211.6)
Prostate-specific antigen (PSA) (ng/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/mL]	71.93 (287.89)

Outcome Measures

1. Primary Outcome

Title	To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
Description	The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
Time Frame	Every 3 months for a minimum of 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sipuleucel-T
Arm/Group Description	sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Measure Participants	1902
Number [events per 100 patient years]	1.2

2. Secondary Outcome

Title	Survival
Description	To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.
Time Frame	Every 3 months for a minimum of 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sipuleucel-T
Arm/Group Description	sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Measure Participants	1902
Median (95% Confidence Interval) [months]	30.7

Adverse Events

Time Frame	All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Arm/Group Title	Sipuleucel-T
Arm/Group Description	sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
All Cause Mortality
	Sipuleucel-T
	Affected / at Risk (%)	# Events
Total	1223/1976 (61.9%)
Serious Adverse Events
	Sipuleucel-T
	Affected / at Risk (%)	# Events
Total	260/1902 (13.7%)
Blood and lymphatic system disorders
Anaemia	7/1902 (0.4%)	14
Disseminated intravascular coagulation	1/1902 (0.1%)	2
Febrile neutropenia	1/1902 (0.1%)	1
Leukocytosis	1/1902 (0.1%)	2
Microcytic anaemia	1/1902 (0.1%)	1
Retroperitoneal lymphadenopathy	1/1902 (0.1%)	1
Thrombocytopenia	1/1902 (0.1%)	1
Cardiac disorders
Acute myocardial infarction	2/1902 (0.1%)	3
Angina unstable	1/1902 (0.1%)	1
Atrial fibrillation	3/1902 (0.2%)	8
Cardiac failure congestive	4/1902 (0.2%)	7
Cardio-respiratory arrest	2/1902 (0.1%)	2
Myocardial infarction	6/1902 (0.3%)	7
Sinus bradycardia	1/1902 (0.1%)	1
Supraventricular tachycardia	1/1902 (0.1%)	1
Tachycardia	1/1902 (0.1%)	1
Ventricular tachycardia	1/1902 (0.1%)	1
Eye disorders
Papilloedema	1/1902 (0.1%)	1
Gastrointestinal disorders
Colitis	1/1902 (0.1%)	1
Abdominal pain	1/1902 (0.1%)	3
Colonic pseudo-obstruction	1/1902 (0.1%)	1
Constipation	3/1902 (0.2%)	3
Diarrhoea	1/1902 (0.1%)	1
Duodenal ulcer	1/1902 (0.1%)	1
Gastric haemorrhage	1/1902 (0.1%)	2
Hiatus hernia	1/1902 (0.1%)	1
Intestinal obstruction	2/1902 (0.1%)	2
Intestinal perforation	1/1902 (0.1%)	1
Intestinal ulcer	1/1902 (0.1%)	1
Nausea	4/1902 (0.2%)	10
Pancreatitis	1/1902 (0.1%)	1
Upper gastrointestinal haemorrhage	1/1902 (0.1%)	1
Vomiting	4/1902 (0.2%)	8
General disorders
Asthenia	3/1902 (0.2%)	6
Chest pain	6/1902 (0.3%)	8
Chills	13/1902 (0.7%)	18
Death	1/1902 (0.1%)	2
Disease progression	28/1902 (1.5%)	37
Gait disturbance	1/1902 (0.1%)	1
Impaired healing	1/1902 (0.1%)	1
Pain	1/1902 (0.1%)	3
Pyrexia	6/1902 (0.3%)	10
Hepatobiliary disorders
Hepatic failure	2/1902 (0.1%)	2
Jaundice	1/1902 (0.1%)	1
Infections and infestations
Bacteraemia	3/1902 (0.2%)	3
Bacterial infection	1/1902 (0.1%)	1
Bronchitis	2/1902 (0.1%)	2
Clostridium difficile colitis	1/1902 (0.1%)	2
Device related infection	10/1902 (0.5%)	10
Device related sepsis	4/1902 (0.2%)	4
Endocarditis staphylococcal	1/1902 (0.1%)	1
Infection	2/1902 (0.1%)	2
Intervertebral discitis	1/1902 (0.1%)	1
Ludwig angina	1/1902 (0.1%)	1
Osteomyelitis	1/1902 (0.1%)	2
Otitis media acute	1/1902 (0.1%)	1
Pneumococcal bacteraemia	1/1902 (0.1%)	1
Pneumonia	5/1902 (0.3%)	7
Salmonella sepsis	1/1902 (0.1%)	1
Sepsis	2/1902 (0.1%)	5
Septic shock	1/1902 (0.1%)	1
Staphylococcal bacteraemia	1/1902 (0.1%)	1
Tooth abscess	1/1902 (0.1%)	1
Upper respiratory tract infection	1/1902 (0.1%)	1
Urinary tract infection	2/1902 (0.1%)	8
Urinary tract infection staphylococcal	1/1902 (0.1%)	1
Injury, poisoning and procedural complications
Cystitis radiation	1/1902 (0.1%)	1
Fall	3/1902 (0.2%)	8
Femur fracture	1/1902 (0.1%)	1
Head injury	1/1902 (0.1%)	1
Hip fracture	1/1902 (0.1%)	1
Infusion related reaction	3/1902 (0.2%)	4
Joint dislocation	1/1902 (0.1%)	1
Laceration	2/1902 (0.1%)	2
Ligament sprain	1/1902 (0.1%)	1
Post concussion syndrome	1/1902 (0.1%)	1
Skull fracture	1/1902 (0.1%)	1
Spinal compression fracture	1/1902 (0.1%)	1
Spinal fracture	1/1902 (0.1%)	1
Subdural haematoma	6/1902 (0.3%)	13
Traumatic intracranial haemorrhage	1/1902 (0.1%)	2
Investigations
Blood potassium increased	1/1902 (0.1%)	1
Blood pressure decreased	1/1902 (0.1%)	1
Blood pressure increased	1/1902 (0.1%)	2
Haemoglobin decreased	1/1902 (0.1%)	1
Oxygen saturation decreased	1/1902 (0.1%)	1
Troponin increased	1/1902 (0.1%)	1
White blood cell count increased	1/1902 (0.1%)	1
Metabolism and nutrition disorders
Dehydration	4/1902 (0.2%)	11
Failure to thrive	1/1902 (0.1%)	1
Hyperkalaemia	2/1902 (0.1%)	2
Hypocalcaemia	1/1902 (0.1%)	1
Hypoglycaemia	1/1902 (0.1%)	1
Hypokalaemia	1/1902 (0.1%)	2
Hyponatraemia	1/1902 (0.1%)	4
Hypovolaemia	2/1902 (0.1%)	2
Malnutrition	1/1902 (0.1%)	1
Musculoskeletal and connective tissue disorders
Back pain	3/1902 (0.2%)	7
Flank pain	1/1902 (0.1%)	1
Musculoskeletal pain	2/1902 (0.1%)	2
Neck pain	1/1902 (0.1%)	2
Pain in extremity	1/1902 (0.1%)	1
Pathological fracture	1/1902 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system	1/1902 (0.1%)	1
Prostate cancer metastatic	2/1902 (0.1%)	2
Prostate cancer stage IV	1/1902 (0.1%)	1
Nervous system disorders
Cauda equina syndrome	2/1902 (0.1%)	2
Central nervous system haemorrhage	1/1902 (0.1%)	1
Cerebral haemorrhage	5/1902 (0.3%)	6
Cerebral infarction	4/1902 (0.2%)	5
Cerebrovascular accident	16/1902 (0.8%)	20
Dizziness	1/1902 (0.1%)	1
Dysarthria	1/1902 (0.1%)	1
Embolic stroke	2/1902 (0.1%)	2
Encephalopathy	1/1902 (0.1%)	2
Haemorrhage intracranial	4/1902 (0.2%)	4
Haemorrhagic stroke	1/1902 (0.1%)	1
Headache	2/1902 (0.1%)	2
Hemiparesis	1/1902 (0.1%)	1
Hemiplegia	1/1902 (0.1%)	1
Hydrocephalus	1/1902 (0.1%)	1
Hydromyelia	1/1902 (0.1%)	1
Intracranial mass	1/1902 (0.1%)	1
Ischaemic stroke	2/1902 (0.1%)	2
Lacunar infarction	1/1902 (0.1%)	1
Lethargy	1/1902 (0.1%)	1
Paralysis	1/1902 (0.1%)	1
Partial seizures	1/1902 (0.1%)	1
Peroneal nerve palsy	1/1902 (0.1%)	1
Presyncope	3/1902 (0.2%)	3
Seizure	1/1902 (0.1%)	1
Spinal cord compression	4/1902 (0.2%)	4
Subarachnoid haemorrhage	1/1902 (0.1%)	3
Syncope	12/1902 (0.6%)	12
Thalamic infarction	1/1902 (0.1%)	1
Transient ischaemic attack	6/1902 (0.3%)	7
Psychiatric disorders
Acute psychosis	1/1902 (0.1%)	1
Anxiety	1/1902 (0.1%)	1
Confusional state	3/1902 (0.2%)	5
Depression	2/1902 (0.1%)	2
Mental status changes	1/1902 (0.1%)	2
Renal and urinary disorders
Acute kidney injury	8/1902 (0.4%)	13
Bladder obstruction	1/1902 (0.1%)	1
Haematuria	3/1902 (0.2%)	5
Hydronephrosis	1/1902 (0.1%)	2
Nephropathy	1/1902 (0.1%)	1
Obstructive uropathy	1/1902 (0.1%)	1
Renal failure	2/1902 (0.1%)	3
Renal injury	1/1902 (0.1%)	1
Ureteric obstruction	1/1902 (0.1%)	3
Urethral stenosis	1/1902 (0.1%)	1
Urinary retention	1/1902 (0.1%)	2
Prostatomegaly	1/1902 (0.1%)	1
Reproductive system and breast disorders
Cough	1/1902 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/1902 (0.1%)	1
Chronic obstructive pulmonary disease	1/1902 (0.1%)	1
Dyspnoea	7/1902 (0.4%)	10
Haemothorax	1/1902 (0.1%)	1
Pleural effusion	1/1902 (0.1%)	2
Pneumonia aspiration	1/1902 (0.1%)	1
Pulmonary embolism	8/1902 (0.4%)	11
Respiratory arrest	1/1902 (0.1%)	1
Respiratory failure	1/1902 (0.1%)	1
Sleep apnoea syndrome	1/1902 (0.1%)	1
Surgical and medical procedures
Fracture reduction	1/1902 (0.1%)	1
Hip arthroplasty	1/1902 (0.1%)	1
Urethral stent insertion	1/1902 (0.1%)	1
Vascular disorders
Aneurysm	1/1902 (0.1%)	1
Blood pressure fluctuation	1/1902 (0.1%)	1
Deep vein thrombosis	8/1902 (0.4%)	10
Hot flush	1/1902 (0.1%)	1
Hypotension	3/1902 (0.2%)	5
Ischaemia	1/1902 (0.1%)	1
Jugular vein thrombosis	1/1902 (0.1%)	2
Orthostatic hypotension	1/1902 (0.1%)	1
Thrombosis	1/1902 (0.1%)	3
Other (Not Including Serious) Adverse Events
	Sipuleucel-T
	Affected / at Risk (%)	# Events
Total	12/1902 (0.6%)
Injury, poisoning and procedural complications
Subdural haematoma	2/1902 (0.1%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage	1/1902 (0.1%)	1
Nervous system disorders
Aphasia	1/1902 (0.1%)	1
Cerebral haemorrhage	1/1902 (0.1%)	1
Cerebral infarction	1/1902 (0.1%)	1
Cerebrovascular accident	2/1902 (0.1%)	3
Ischaemic stroke	1/1902 (0.1%)	1
Seizure	1/1902 (0.1%)	1
Transient ischaemic attack	2/1902 (0.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.