Drug

sipuleucel-T

In clinical development

ClassProstatic acid phosphatase binding agentEmerging researchLate-stage developmentSteady momentum

Also known as Provenge.

RxNorm997261 ChEMBLCHEMBL1237024 ATCL03AX17UNII8Q622VDR18

Research papers

Active clinical trials

Prostatic acid phosphatase

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Clinical trial2026-07-01Results expected Q4 2027 · ClinicalTrials.gov

Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)

Clinical trial2026-05-13Primary completion · ClinicalTrials.gov

Pilot Study of ¹⁷⁷Lu-PSMA-617 in Combination With Sipuleucel-T in Patients With Metastatic Castration-Resistant Prostate Cancer

Clinical trial2026-04-20Results expected Q3 2028 · ClinicalTrials.gov

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

Clinical trial2025-08-27Results expected Q4 2031 · ClinicalTrials.gov

A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer

Clinical trial2024-10-08Results posted · ClinicalTrials.gov

A Phase II Randomized Open Label Study of Sipuleucel-T vs. Sipuleucel-T and Tasquinimod in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC)

Clinical trial2023-04-27Results posted · ClinicalTrials.gov

Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Clinical trial2022-05-06Results posted · ClinicalTrials.gov

Moving on From Sipuleucel-T: New Dendritic Cell Vaccine Strategies for Prostate Cancer.

Research2021-03-29Frontiers in immunology

Prime-boost vaccination targeting prostatic acid phosphatase (PAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) using Sipuleucel-T and a DNA vaccine.

Research2018-03-13Journal for immunotherapy of cancer

PROVENGE (Sipuleucel-T) in prostate cancer: the first FDA-approved therapeutic cancer vaccine.

Research2011-04-06Clinical cancer research : an official journal of the American Association for Cancer Research

Sipuleucel-T immunotherapy for castration-resistant prostate cancer.

Research2010-07-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

sipuleucel-T

Aliases & brands

Provenge

RxNorm CUI

997261

ChEMBL ID

CHEMBL1237024

ATC codes

L03AX17

UNII

8Q622VDR18

Primary mechanism

Prostatic acid phosphatase binding agent

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Prostatic acid phosphatase

ACP3 · P15309

BINDING AGENTProstatic acid phosphatase binding agent

Clinical trials

30 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2023

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 30

Phase 15Phase 220Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer

CompletedPH IIIDendreonn=5322023

Autologous PAP-loaded Dendritic Cell Vaccine (Sipuleucel-T, APC8015, Provenge®) in Patients With Non-metastatic Prostate Cancer Who Experience PSA Elevation Following Radical Prostatectomy: a Randomized, Controlled, Double-blind Trial

CompletedPH IIIDendreonn=1762015

A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma

CompletedPH IIIDendreonn=5122009

A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

CompletedPH IIIDendreonn=982005

A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer

CompletedPH IIIDendreonn=1272004

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer

CompletedPH IIIDendreonn=5322023

Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

CompletedPH IIUniversity of Texas Southwestern Medical Centern=202021

Phase Ib Study Assessing Different Sequencing Regimens of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients Who Have Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

CompletedPH IUniversity of Hawaiin=372020

Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer

CompletedPH IIUniversity of Wisconsin, Madisonn=182020

Randomized Phase II Trial of Sipuleucel T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer

CompletedPH IICity of Hope Medical Centern=512019

A Phase 2 Study of Sipuleucel-T With or Without Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-Metastatic Castrate-Resistant Prostate Cancer

CompletedPH IISidney Kimmel Comprehensive Cancer Center at Johns Hopkinsn=362019

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20062021

Most influential

Sipuleucel-T immunotherapy for castration-resistant prostate cancer.

The New England journal of medicine · 2010 · 4,000 cites

Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2006 · 796 cites

PROVENGE (Sipuleucel-T) in prostate cancer: the first FDA-approved therapeutic cancer vaccine.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2011 · 548 cites

Moving on From Sipuleucel-T: New Dendritic Cell Vaccine Strategies for Prostate Cancer.

Frontiers in immunology · 2021 · 74 cites

Prime-boost vaccination targeting prostatic acid phosphatase (PAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) using Sipuleucel-T and a DNA vaccine.

Journal for immunotherapy of cancer · 2018 · 48 cites

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Prostatic Neoplasms3

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials