Sipuleucel-T

also known as Provenge · APC8015

Developed for: prostate cancer · castration-resistant prostate carcinoma · metastatic prostate carcinoma · prostate adenocarcinoma · hormone-resistant prostate carcinoma · malignant soft tissue neoplasm · metastatic carcinoma in the bone · prostate carcinoma
Investigated by: Dendreon · National Cancer Institute (NCI) · City of Hope Medical Center · The University of Texas Health Science Center, Houston · Active Biotech AB · Bayer
+14 more
· Duke University · Genentech, Inc. · PRA Health Sciences · Prostate Oncology Specialists, Inc. · Roswell Park Cancer Institute · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Talosix · University of California, San Francisco · University of Hawaii · University of Oklahoma · University of Texas Southwestern Medical Center · University of Wisconsin, Madison · WCG IRB · Yale University

Trials 24

today NCT07219147 · Ph 1 NCT06100705 · Ph 2 NCT05806814 · Ph 1 NCT06134232 · Ph 2 NCT03686683 · Ph 3 NCT03024216 · Ph 1 NCT02793219 · Ph 2 NCT02793765 · Ph 2 NCT02463799 · Ph 2 NCT02159950 · Ph 2 NCT02036918 · Ph 1 NCT01981122 · Ph 2 NCT01818986 · Ph 2 NCT01807065 · Ph 2 NCT01706458 · Ph 2 NCT01832870 · Ph 1 NCT01477749 · Ph 2 NCT01487863 · Ph 2 NCT01338012 · Ph 2 NCT01431391 · Ph 2 NCT00901342 · Ph 2 NCT00715104 · Ph 2 NCT00027599 · Ph 2 NCT00779402 · Ph 3

20012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029203020312032

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 15 trials
Phase 1	NCT07219147	Mar 2026 → Jul 2028 expected	prostate adenocarcinoma	City of Hope Medical Center	Recruiting	No outcome recorded
Phase 1	NCT05806814	Nov 2023 → May 2026 overdue	castration-resistant prostate carcinoma	University of Oklahoma	Active not recruiting	No outcome recorded
Phase 1	NCT03024216	Feb 2017 → Dec 2020	metastatic prostate carcinoma	University of Hawaii	Completed	No outcome recorded
Phase 1	NCT02036918	Mar 2014 → Feb 2019	prostate cancer	Duke University	Completed	No outcome recorded
Phase 1	NCT01832870	Apr 2013 → Feb 2016	castration-resistant prostate carcinoma	Prostate Oncology Specialists, Inc.	Completed	No outcome recorded
Phase 217 trials · 4 missed
Phase 2	NCT06100705	Dec 2023 → Dec 2027 expected	castration-resistant prostate carcinoma	Yale University	Recruiting	No outcome recorded
Phase 2	NCT06134232	Oct 2023 → Dec 2031 expected	castration-resistant prostate carcinoma	Dendreon	Recruiting	No outcome recorded
Phase 2	NCT02793219	Dec 2016 → Jul 2018	prostate cancer	The University of Texas Health Science Center, Houston	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT02793765	Dec 2016 → Jul 2018	prostate cancer	The University of Texas Health Science Center, Houston	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT02463799	Feb 2016 → Dec 2019	prostate cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Completed	Missed primary
Phase 2	NCT02159950	Jan → Jul 2015	hormone-resistant prostate carcinoma, metastatic prostate carcinoma	Roswell Park Cancer Institute	Completed	No outcome recorded
Phase 2	NCT01981122	Sep 2013 → Jun 2017	metastatic prostate carcinoma	Dendreon	Completed	Missed primary
Phase 2	NCT01818986	Jul 2013 → Dec 2019	prostate carcinoma	University of Texas Southwestern Medical Center	Completed	No outcome recorded
Phase 2	NCT01807065	Jun 2013 → Dec 2018	hormone-resistant prostate carcinoma, malignant soft tissue neoplasm, metastatic carcinoma in the bone, prostate adenocarcinoma	City of Hope Medical Center	Completed	Missed primary
Phase 2	NCT01706458	May 2013 → Jun 2017	prostate cancer	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 2	NCT01477749	Jun 2012 → Jun 2014	prostate cancer	Dendreon	Completed	No outcome recorded
Phase 2	NCT01487863	Dec 2011 → May 2016	castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma, metastatic prostate carcinoma	Dendreon	Completed	Missed primary
Phase 2	NCT01338012	Dec 2011 → Apr 2015	prostate cancer	Dendreon	Terminated	No outcome recorded
Phase 2	NCT01431391	Sep 2011 → Dec 2014	prostate adenocarcinoma	Dendreon	Completed	No outcome recorded
Phase 2	NCT00901342	Oct 2009 → Dec 2014	prostate cancer	Dendreon	Completed	No outcome recorded
Phase 2	NCT00715104	Jul 2008 → Dec 2012	prostate cancer	Dendreon	Completed	Mixed
Phase 2	NCT00027599	Dec 2001 → Jul 2007	prostate cancer	National Cancer Institute (NCI)	Completed	No outcome recorded

Phase 32 trials · 2 missed
Phase 3	NCT03686683	Oct 2018 → Mar 2023	prostate adenocarcinoma	Dendreon	Completed	Missed primary
Phase 3	NCT00779402	Oct 2001 → Aug 2006	prostate cancer	Dendreon	Completed	Missed primary
Comparator or background therapy7 trials
Phase 2	NCT05751941 Background	Feb 2023 → Jul 2026 overdue	metastatic prostate carcinoma	H. Lee Moffitt Cancer Center and Research Institute	Active not recruiting	No outcome recorded
Phase 2	NCT01804465 Background	Apr 2014 → Feb 2020	prostate cancer	University of California, San Francisco	Completed	Missed primary
Phase 2	NCT01560923 Background	Oct 2012 → Dec 2018	metastatic prostate carcinoma	Masonic Cancer Center, University of Minnesota	Completed	No outcome recorded
Phase 2	NCT00715078 Comparator	Oct 2008 → Apr 2012	prostate cancer	Dendreon	Completed	No outcome recorded
Phase 3	NCT00065442 Comparator	Jul 2003 → Jan 2009	prostate cancer	Dendreon	Completed	No outcome recorded
Phase 3	NCT01133704 Comparator	May 2000 → Mar 2003	hormone-resistant prostate carcinoma	Dendreon	Completed	No outcome recorded
Phase 3	NCT00005947 Comparator	Nov 1999 → Sep 2004	prostate cancer	Dendreon	Completed	No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 31 sources stand behind the page.

Field	Value	Cited text
Known as	Sipuleucel-T	“Sipuleucel-T is a US Food and Drug Administration-approved autologous cellular immunotherapy that improves survival in patients with metastatic castration-resistant prostate...” PMID 33986125 ↗ May 2021 30 NCT05751941 ↗ NCT01981122 ↗ NCT03686683 ↗ NCT01807065 ↗ NCT00065442 ↗ NCT01818986 ↗ NCT02463799 ↗ NCT00005947 ↗ NCT00715104 ↗ NCT02793219 ↗ Show 20 more sources
Known as	APC8015	“sipuleucel-T (APC8015)” NCT01133704 ↗
Known as	Provenge	“Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single...” NCT06134232 ↗ 2 “An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer” NCT00715104 ↗ “Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer” NCT01133704 ↗
Action	Deplete	“they may stimulate T cells to kill prostate tumor cells.” NCT07219147 ↗
Modality	Cell therapy	“Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF.” NCT00005947 ↗
Route	Intravenous	“Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes” NCT00005947 ↗