A Randomized, Double-blind, Phase II Trial of PSA-TRICOM (PROSTVAC) in Patients with Localized Prostate Cancer: The Immunotherapy to Prevent Progression on Active Surveillance Study

doi:10.1016/j.euf.2018.08.016

Clinical Trial

. 2018 Sep;4(5):636-638.

doi: 10.1016/j.euf.2018.08.016. Epub 2018 Sep 7.

A Randomized, Double-blind, Phase II Trial of PSA-TRICOM (PROSTVAC) in Patients with Localized Prostate Cancer: The Immunotherapy to Prevent Progression on Active Surveillance Study

J Kellogg Parsons¹, Peter A Pinto², Christian P Pavlovich³, Edward Uchio⁴, Hyung L Kim⁵, Mikel N Nguyen⁶, James L Gulley², Christina Jamieson⁷, Paul Hsu⁸, Margarita Wojtowicz², Howard Parnes², Jeffrey Schlom², William L Dahut², Ravi A Madan², Renee N Donahue², H-H Sherry Chow⁸

Affiliations

¹ Department of Urology, UC San Diego Moores Cancer Center, La Jolla, CA, USA. Electronic address: jkparsons@ucsd.edu.
² National Cancer Institute, Bethesda, MD, USA.
³ Department of Urology, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.
⁴ Department of Urology, UC Irvine, Orange, CA, USA.
⁵ Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁶ Department of Urology, University of Southern California, Los Angeles, CA, USA.
⁷ Department of Urology, UC San Diego Moores Cancer Center, La Jolla, CA, USA.
⁸ University of Arizona Cancer Center, Tucson, AZ, USA.

PMID: 30197041
PMCID: PMC7524340
DOI: 10.1016/j.euf.2018.08.016

Clinical Trial

A Randomized, Double-blind, Phase II Trial of PSA-TRICOM (PROSTVAC) in Patients with Localized Prostate Cancer: The Immunotherapy to Prevent Progression on Active Surveillance Study

J Kellogg Parsons et al. Eur Urol Focus. 2018 Sep.

. 2018 Sep;4(5):636-638.

doi: 10.1016/j.euf.2018.08.016. Epub 2018 Sep 7.

Authors

Affiliations

¹ Department of Urology, UC San Diego Moores Cancer Center, La Jolla, CA, USA. Electronic address: jkparsons@ucsd.edu.
² National Cancer Institute, Bethesda, MD, USA.
³ Department of Urology, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.
⁴ Department of Urology, UC Irvine, Orange, CA, USA.
⁵ Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁶ Department of Urology, University of Southern California, Los Angeles, CA, USA.
⁷ Department of Urology, UC San Diego Moores Cancer Center, La Jolla, CA, USA.
⁸ University of Arizona Cancer Center, Tucson, AZ, USA.

PMID: 30197041
PMCID: PMC7524340
DOI: 10.1016/j.euf.2018.08.016

Abstract

The Immunotherapy to Prevent Progression on Active Surveillance Study is the first trial of immunotherapy for localized prostate cancer. We randomized active surveillance patients to PSA-TRICOM (PROSTVAC) or placebo for 5mo. Final results will be available in 2019.

Trial registration: ClinicalTrials.gov NCT02326805.

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Conflict of interest statement

Conflicts of interest: The authors have nothing to disclose.

Figures

**Fig. 1 –**
Screening and randomization of men enrolled in the Immunotherapy to Prevent Progression on Active Surveillance Study.

See this image and copyright information in PMC

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References

1. Gulley JL, Arlen PM, Madan RA, et al. Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol Immunother 2010;59:663–74. - PMC - PubMed
1. Gulley JL, Madan RA, Schlom J. Impact of tumour volume on the potential efficacy of therapeutic vaccines. Curr Oncol 2011;18: e150–7. - PMC - PubMed
1. Bilusic M, Gulley JL. Endpoints, patient selection, and biomarkers in the design of clinical trials for cancer vaccines. Cancer Immunol Immunother 2012;61:109–17. - PMC - PubMed
1. Gulley JL, Heery CR, Madan RA, et al. Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer. Cancer Immunol Immunother 2013;62:1521–31. - PMC - PubMed
1. Bul M, Zhu X, Valdagni R, et al. Active surveillance for low-risk prostate cancer worldwide: the PRIAS study. Eur Urol 2013;63:597–603. - PubMed

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[1] Gulley JL, Arlen PM, Madan RA, et al. Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol Immunother 2010;59:663–74. - PMC - PubMed

[2] Gulley JL, Arlen PM, Madan RA, et al. Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol Immunother 2010;59:663–74. - PMC - PubMed

[3] Gulley JL, Madan RA, Schlom J. Impact of tumour volume on the potential efficacy of therapeutic vaccines. Curr Oncol 2011;18: e150–7. - PMC - PubMed

[4] Gulley JL, Madan RA, Schlom J. Impact of tumour volume on the potential efficacy of therapeutic vaccines. Curr Oncol 2011;18: e150–7. - PMC - PubMed

[5] Bilusic M, Gulley JL. Endpoints, patient selection, and biomarkers in the design of clinical trials for cancer vaccines. Cancer Immunol Immunother 2012;61:109–17. - PMC - PubMed

[6] Bilusic M, Gulley JL. Endpoints, patient selection, and biomarkers in the design of clinical trials for cancer vaccines. Cancer Immunol Immunother 2012;61:109–17. - PMC - PubMed

[7] Gulley JL, Heery CR, Madan RA, et al. Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer. Cancer Immunol Immunother 2013;62:1521–31. - PMC - PubMed

[8] Gulley JL, Heery CR, Madan RA, et al. Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer. Cancer Immunol Immunother 2013;62:1521–31. - PMC - PubMed

[9] Bul M, Zhu X, Valdagni R, et al. Active surveillance for low-risk prostate cancer worldwide: the PRIAS study. Eur Urol 2013;63:597–603. - PubMed

[10] Bul M, Zhu X, Valdagni R, et al. Active surveillance for low-risk prostate cancer worldwide: the PRIAS study. Eur Urol 2013;63:597–603. - PubMed

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A Randomized, Double-blind, Phase II Trial of PSA-TRICOM (PROSTVAC) in Patients with Localized Prostate Cancer: The Immunotherapy to Prevent Progression on Active Surveillance Study

Affiliations

A Randomized, Double-blind, Phase II Trial of PSA-TRICOM (PROSTVAC) in Patients with Localized Prostate Cancer: The Immunotherapy to Prevent Progression on Active Surveillance Study

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

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Cited by

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LinkOut - more resources

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Medical

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Cited by

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