Evidence map›Paper›PMID 31483485›Full record

ArticleCancer2019

Real-world outcomes of sipuleucel-T treatment in PROCEED, a prospective registry of men with metastatic castration-resistant prostate cancer.

Celestia S Higano, Andrew J Armstrong, A Oliver Sartor, Nicholas J Vogelzang, Philip W Kantoff, David G McLeod, Christopher M Pieczonka, David F Penson, Neal D Shore, Jeffrey Vacirca and 11 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01306890 (A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01306890 completednot on this map

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

TypeobservationalSponsorDendreonRan2011 to 2017Enrolled1,976ConditionsAdvanced Prostate Cancer, Prostatic NeoplasmsArmssipuleucel-T
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

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  14. Therapeutic Vaccination in Lung Cancer: Past Attempts, Current Approaches and Future Promises.Journal of respiratory biology and translational medicine · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 1 country.

Celestia S HiganoDivision of Medical Oncology, Departments of Medicine and Urology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington.
Andrew J ArmstrongDivision of Medical Oncology, Duke University Medical Center, Duke Cancer Institute, Duke University, Durham, North Carolina.ORCID 0000-0001-7012-1754
A Oliver SartorSection of Hematology and Medical Oncology, Department of Medicine, Tulane Cancer Center and Tulane University School of Medicine, New Orleans, Louisiana.ORCID 0000-0002-8777-7343
Nicholas J VogelzangDivision of Hematology/Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada.
Philip W KantoffDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.
David G McLeodDepartment of Surgery, Center for Prostate Disease Research at the Uniformed Services of Health Sciences, Bethesda, Maryland.
Christopher M PieczonkaAssociated Medical Professionals, Syracuse, New York.
David F PensonDepartment of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
Neal D ShoreDepartment of Urology, Carolina Urologic Research Center, Myrtle Beach, South Carolina.
Jeffrey VacircaNew York Cancer and Blood Specialists, New York, New York.
Raoul S ConcepcionUrology Associates PC, Nashville, Tennessee.
Ronald F TutroneChesapeake Urology, Towson, Maryland.
Luke T NordquistDepartment of Medical Oncology, GU Research Network, Omaha, Nebraska.
David I QuinnDivision of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California.
Vahan KassabianAdvanced Urology, Atlanta, Georgia.
Mark C ScholzProstate Cancer Research Institute, Marina del Rey, California.
Matt HarmonDepartment of Biometrics, Dendreon Pharmaceuticals LLC, Seattle, Washington.
Robert C TylerDepartment of Medical Affairs, Dendreon Pharmaceuticals LLC, Seattle, Washington.
Nancy N ChangDepartment of Medical Affairs, Dendreon Pharmaceuticals LLC, Seattle, Washington.
Hong TangDepartment of Medical Affairs, Dendreon Pharmaceuticals LLC, Seattle, Washington.
Matthew R CooperbergDepartment of Urology, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California.
Dendreon (United States) · USCancer Research Institute · USCarolina Urologic Research Center · USChesapeake Urology Associates · USComprehensive Cancer Centers of Nevada · USDuke Medical Center · USGeorgia Urology · USMemorial Sloan Kettering Cancer Center · USSUNY Upstate Medical University · USTulane University · USUniformed Services University of the Health Sciences · USUniversity of California, San Francisco · USUniversity of Southern California · USUniversity of Washington · USUrology Associates · USUrology Cancer Center and GU Research Network · USVanderbilt University Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Targeting convergent oncogenic signaling during AR inhibition to overcome metastasis and immune evasion in prostate cancerR01CA233585 · NCI · DUKE UNIVERSITY · PI ARMSTRONG, ANDREW J · 2019 to 2023
$2.2M
Dendreon Pharmaceuticals LLCNCI NIH HHS P30 CA008748NCI NIH HHS R01 CA233585
6 · The paper itself

Abstract

backgroundThe large registry, PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data (PROCEED)(NCT01306890), evaluated sipuleucel-T immunotherapy for asymptomatic/minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

methodsPROCEED enrolled patients with mCRPC receiving 3 biweekly sipuleucel-T infusions. Assessments included overall survival (OS), serious adverse events (SAEs), cerebrovascular events (CVEs), and anticancer interventions (ACIs). Follow-up was for ≥3 years or until death or study withdrawal.

resultsIn 2011-2017, 1976 patients were followed for 46.6 months (median). The median age was 72 years, and the baseline median prostate-specific antigen level was 15.0 ng/mL; 86.7% were white, and 11.6% were African American. Among the patients, 1902 had 1 or more sipuleucel-T infusions. The median OS was 30.7 months (95% confidence interval [CI], 28.6-32.2 months). Known prognostic factors were independently associated with OS in a multivariable analysis. Among the 1255 patients who died, 964 (76.8%) died of prostate cancer (PC) progression. The median time from the first infusion to PC death was 42.7 months (95% CI, 39.4-46.2 months). The incidence of sipuleucel-T-related SAEs was 3.9%. The incidence of CVEs was 2.8%, and the rate per 100 person-years was 1.2 (95% CI, 0.9-1.6). The CVE incidence among 11,972 patients with mCRPC from the Surveillance, Epidemiology, and End Results-Medicare database was 2.8%; the rate per 100 person-years was 1.5 (95% CI, 1.4-1.7). One or more ACIs (abiraterone, enzalutamide, docetaxel, cabazitaxel, or radium 223) were received by 77.1% of the patients after sipuleucel-T; 32.5% and 17.4% of the patients experienced 1- and 2-year treatment-free intervals, respectively.

conclusionsPROCEED provides contemporary survival data for sipuleucel-T-treated men in a real-world setting of new life-prolonging agents, which will be useful in discussing treatment options with patients and in powering future trials with sipuleucel-T. The safety and tolerability of sipuleucel-T in PROCEED were consistent with previous findings.

Indexed as

AgedHumansMaleNeoplasm MetastasisProspective StudiesProstatic Neoplasms, Castration-ResistantRegistriesTissue Extractssipuleucel-TTissue Extractsimmunotherapyoverall survivalprostate cancersafety

Identifiers

PMID31483485
PMCPMC6856402
OpenAlexW2972301460

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.