PROVENGE (Sipuleucel-T) in Prostate Cancer: The First FDA-Approved Therapeutic Cancer Vaccine
Abstract
Sipuleucel-T (PROVENGE; Dendreon) is the first therapeutic cancer vaccine to be approved by the U.S. Food and Drug Administration. In men who have metastatic castration-resistant prostate cancer with no or minimal symptoms, sipuleucel-T prolongs median survival by 4.1 months compared with results in those treated with placebo. At 3 years, the proportion of patients in the vaccine group who were alive was 50% higher than that in the control group (31.7% versus 21.7%, respectively). Sipuleucel-T, which is designed to elicit an immune response to prostatic acid phosphatase, uses the patient's own immune system to recognize and combat his cancer. Currently, no other agents are available that offer a survival benefit for this population of asymptomatic patients who have not been treated with chemotherapy, except for docetaxel (whose inherent toxicities often lead patients and physicians to delay administration until symptoms develop). Straightforward strategies to increase the efficacy of sipuleucel-T are likely to provide even greater benefit. The preclinical and clinical development of sipuleucel-T is reviewed, and approaches to enhance efficacy are considered herein. Clin Cancer Res; 17(11); 3520–6. ©2011 AACR.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Other FDA approved adoptive cell therapies are sipuleucel-T (Provenge) and umbilical cord blood stem cells.
“Other FDA approved adoptive cell therapies are sipuleucel-T (Provenge, used to treat prostate cancer) and umbilical cord blood stem cells.325”
From Smart nanoparticles for cancer therapy (2023) · cites this paper as [325]
Cites
Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Tannock, I. F., de Wit, R., Berry, W. R., Horti, J., Pluzanska, A., Chi, K. N., Oudard, S., Théodore, C., James, N. D., Turesson, I., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa040720 · Cited by 5,735 · see citing works
Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer
Kantoff, P. W., Higano, C. S., Shore, N. D., Berger, E. R., Small, E. J., Penson, D. F., Redfern, C. H., Ferrari, A. C., Dreicer, R., Sims, R. B., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1001294 · Cited by 5,572 · see citing works
Self-citationPetrylak, D. P., Tangen, C. M., Hussain, M., Lara, P. N., Jones, J. A., Taplin, M. E., Burch, P. A., Berry, D. L., Moinpour, C. M., Kohli, M., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa041318 · Cited by 3,665 · see citing works
Scher, H. I., Halabi, S., Tannock, I. F., Morris, M. J., Sternberg, C. N., Carducci, M. A., Eisenberger, M. A., Higano, C. S., Bubley, G. J., Dreicer, R., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.12.4487 · Cited by 2,228 · see citing works
Self-citationKantoff, P. W., Schuetz, T. J., Blumenstein, B. A., Glodé, L. M., Bilhartz, D. L., Wyand, M. S., Manson, K. H., Panicali, D., Laus, R., Schlom, J., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.25.0597 · Cited by 981 · see citing works
Higano, C. S., Schellhammer, P. F., Small, E. J., Burch, P. A., Nemunaitis, J. J., Yuh, L., Provost, N. M., & Frohlich, M. W. (2009) · Cancer · doi:10.1002/cncr.24429 · Cited by 809 · see citing works
Self-citationPrognostic Model for Predicting Survival in Men With Hormone-Refractory Metastatic Prostate Cancer
Halabi, S., Small, E. J., Kantoff, P. W., Kattan, M. W., Kaplan, E. B., Dawson, N. A., Levine, E. G., Blumenstein, B. A., & Vogelzang, N. J. (2003) · Journal of Clinical Oncology · doi:10.1200/jco.2003.06.100 · Cited by 673 · see citing works
Immunotherapy of Hormone-Refractory Prostate Cancer With Antigen-Loaded Dendritic Cells
Small, E. J., Fratesi, P., Reese, D., Strang, G., Laus, R., Peshwa, M. V., & Valone, F. H. (2000) · Journal of Clinical Oncology · doi:10.1200/jco.2000.18.23.3894 · Cited by 625 · see citing works
Danila, D. C., Morris, M. J., de Bono, J. S., Ryan, C. J., Denmeade, S. R., Smith, M. R., Taplin, M.-E., Bubley, G. J., Kheoh, T., Haqq, C., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.25.9259 · Cited by 410 · see citing works
Ryan, C. J., Smith, M. R., Fong, L., Rosenberg, J. E., Kantoff, P., Raynaud, F., Martins, V., Lee, G., Kheoh, T., Kim, J., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.24.1281 · Cited by 396 · see citing works
Reid, A. H. M., Attard, G., Danila, D. C., Oommen, N. B., Olmos, D., Fong, P. C., Molife, L. R., Hunt, J., Messiou, C., Parker, C., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.24.6819 · Cited by 394 · see citing works
Twelve immunotherapy drugs that could cure cancers
Cheever, M. A. (2008) · Immunological Reviews · doi:10.1111/j.1600-065x.2008.00604.x · Cited by 339 · see citing works
Self-citationMarkowicz, S., & Engleman, E. G. (1990) · Journal of Clinical Investigation · doi:10.1172/jci114525 · Cited by 265 · see citing works
Burch, P. A., Breen, J. K., Buckner, J. C., Gastineau, D. A., Kaur, J. A., Laus, R., Padley, D. J., Peshwa, M. V., Pitot, H. C., Richardson, R. L., et al. (2000) · PubMed · Cited by 263 · see citing works
Burch, P. A., Croghan, G. A., Gastineau, D. A., et al. (2004) · The Prostate · doi:10.1002/pros.20040 · Cited by 190 · see citing works
Elevation of cytokine levels in cachectic patients with prostate carcinoma
Pfitzenmaier, J., Vessella, R. L., Higano, C. S., Noteboom, J. L., Wallace, D., & Corey, E. (2003) · Cancer · doi:10.1002/cncr.11178 · Cited by 167 · see citing works
Self-citationTherapy of advanced prostate cancer with granulocyte macrophage colony-stimulating factor.
Small, E. J., Reese, D., Um, B., Whisenant, S. P., Dixon, S. C., & Figg, W. D. (1999) · PubMed · Cited by 145 · see citing works
Estimation of Cachexia among Cancer Patients Based on Four Definitions
Fox, K. M., Brooks, J. M., Gandra, S. R., et al. (2009) · Journal of Oncology · doi:10.1155/2009/693458 · Cited by 144 · see citing works
Rini, B. I., WEINBERG, V. K., Fong, L. H., Conry, S., Hershberg, R. M., & Small, E. J. (2006) · Cancer · doi:10.1002/cncr.21956 · Cited by 128 · see citing works
New concepts in tissue specificity for prostate cancer and benign prostatic hyperplasia
Marzo, A. M. D., Coffey, D. S., & Nelson, W. G. (1999) · Urology · doi:10.1016/s0090-4295(98)00536-6 · Cited by 118 · see citing works
CD54 is a surrogate marker of antigen presenting cell activation
Sheikh, N. A., & Jones, L. A. (2008) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-008-0474-9 · Cited by 115 · see citing works
Interleukin 6 Is Associated with Cachexia in Patients with Prostate Cancer
Kuroda, K., Nakashima, J., Kanao, K., Kikuchi, E., Miyajima, A., Horiguchi, Y., Nakagawa, K., Oya, M., Ohigashi, T., & Murai, M. (2007) · Urology · doi:10.1016/j.urology.2006.09.039 · Cited by 113 · see citing works
Prostatic Acid Phosphatase Is Not a Prostate Specific Target
Quintero, I. B., Araujo, C. L., Pulkka, A. E., Wirkkala, R. S., Herrala, A. M., Eskelinen, E., Jokitalo, E., Hellström, P. A., Tuominen, H. J., Hirvikoski, P. P., et al. (2007) · Cancer Research · doi:10.1158/0008-5472.can-07-1651 · Cited by 107 · see citing works
Liu, K., Chatta, G. S., Twardzik, D. R., et al. (1997) · The Journal of Immunology · doi:10.4049/jimmunol.159.1.472 · Cited by 45 · see citing works
Technology evaluation: APC-8015, Dendreon.
Rini, B. I. (2002) · PubMed · Cited by 42 · see citing works
Abiraterone Acetate Is Well Tolerated Without Concomitant Use of Corticosteroids
Attard, G., Reid, A. H. M., & de Bono, J. S. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2010.29.5170 · Cited by 35 · see citing works
Beer, T. M., Bernstein, G. T., Corman, J. M., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2007.25.18_suppl.5059 · Cited by 13 · see citing works
Sheikh, N. A., Rosa, C. P. D., Frohlich, M. W., et al. (2010) · Cancer Research · doi:10.1158/1538-7445.am10-5608 · Cited by 8 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
The evolution of commercial drug delivery technologies
Vargason, A. M., Anselmo, A. C., & Mitragotri, S. (2021) · Nature Biomedical Engineering · doi:10.1038/s41551-021-00698-w · Cited by 1,361 · see citing works
Smart nanoparticles for cancer therapy
Sun, L., Liu, H., Ye, Y., Lei, Y., Islam, R., Tan, S., Tong, R., Miao, Y.-B., & Cai, L. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01642-x · Cited by 1,073 · see citing works
Engineering cancer microenvironments for in vitro 3-D tumor models
Asghar, W., El Assal, R., Shafiee, H., Pitteri, S., Paulmurugan, R., & Demirci, U. (2015) · Materials Today · doi:10.1016/j.mattod.2015.05.002 · Cited by 316 · see citing works
Poly(Ethylene Glycol)–Polylactide Micelles for Cancer Therapy
Wang, J., Li, S., Han, Y., Guan, J., Chung, S., Wang, C., & Li, D. (2018) · Frontiers in Pharmacology · doi:10.3389/fphar.2018.00202 · Cited by 155 · see citing works
The paradigm shift in treatment from Covid-19 to oncology with mRNA vaccines
Wei, J., & Hui, A.-M. (2022) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2022.102405 · Cited by 57 · see citing works
Hardwick, N. R., Carroll, M., Kaltcheva, T., Qian, D., Lim, D., Leong, L., Chu, P., Kim, J., Chao, J., Fakih, M., et al. (2014) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-13-3361 · Cited by 45 · see citing works
Cohn, A., Morse, M. A., O’Neil, B., Whiting, S., Coeshott, C., Ferraro, J., Bellgrau, D., Apelian, D., & Rodell, T. C. (2018) · Journal of Immunotherapy · doi:10.1097/cji.0000000000000219 · Cited by 41 · see citing works
An in-depth review of AI-powered advancements in cancer drug discovery
Le, M. H. N., Nguyen, P. K., Nguyen, T. P. T., Nguyen, H. Q., Tam, D. N. H., Huynh, H. H., Huynh, P. K., & Le, N. Q. K. (2025) · Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease · doi:10.1016/j.bbadis.2025.167680 · Cited by 15 · see citing works
- Authors
- Cheever, M. A., & Higano, C. S.
- Affiliations
- University of Washington (US)
- Corresponding author
- Cheever, Martin A.
- Venue
- Clinical Cancer Research
- Published
- 2011-06-01
- Volume
- 17
- Issue
- 11
- Pages
- 3520-3526
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- OpenAlex
- W2142447995
- Cited by
- 780
- References
- 28
- Citations by year
- 2026: 41 · 2025: 92 · 2024: 79 · 2023: 66 · 2022: 74 · 2021: 78 · 2020: 46 · 2019: 50 · 2018: 36 · 2017: 29 · 2016: 34 · 2015: 29 · 2014: 41 · 2013: 28 · 2012: 38
- FWCI
- 33.72
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (CA015704, P30CA015704)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Keywords
- sipuleucel-T, therapeutic cancer vaccines, metastatic castration-resistant prostate cancer, prostatic acid phosphatase, immune response, docetaxel, survival benefit, FDA approval
- MeSH terms
- Acid Phosphatase, Clinical Trials as Topic, Humans, Immunization, Leukocytes, Mononuclear, Male, Prostatic Neoplasms, Recombinant Fusion Proteins, Tissue Extracts, United States, United States Food and Drug Administration, Granulocyte-Macrophage Colony-Stimulating Factor, Protein Tyrosine Phosphatases, Drug Approval, Cancer Vaccines
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
