Evidence map›Paper›PMID 32025848›Full record

Trial reportCancer immunology, immunotherapy : CII2020

Mixed 20-peptide cancer vaccine in combination with docetaxel and dexamethasone for castration-resistant prostate cancer: a randomized phase II trial.

Masanori Noguchi, Gaku Arai, Shin Egawa, Chikara Ohyama, Seiji Naito, Kazumasa Matsumoto, Hirotsugu Uemura, Masayuki Nakagawa, Yasutomo Nasu, Masatoshi Eto and 6 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
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  5. Bolstering CD8Biology · 2025
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  8. Toll-like receptor agonists as cancer vaccine adjuvants.Human vaccines & immunotherapeutics · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 1 country.

Masanori NoguchiCanver Vaccine Center, Kurume University School of Medicine, 67 Asahi-machi, Kurume, 830-0011, Japan. noguchi@med.kurume-u.ac.jp.ORCID http://orcid.org/0000-0003-2328-4985
Gaku AraiDepartment of Urology, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan.
Shin EgawaDepartment of Urology, Jikei University School of Medicine, Tokyo, Japan.
Chikara OhyamaDepartment of Urology, Graduate School of Medicine and School of Medicine, Hirosaki University, Hirosaki, Japan.
Seiji NaitoSanshinkai Hara Hospital, Fukuoka, Japan.
Kazumasa MatsumotoDepartment of Urology, Kitasato University School of Medicine, Kanagawa, Japan.
Hirotsugu UemuraDepartment of Urology, Kinki University Faculty of Medicine, Osaka, Japan.
Masayuki NakagawaDepartment of Urology, Kagoshima University Graduate School of Medical and Dental Science, Kagoshima, Japan.
Yasutomo NasuDepartment of Urology, Okayama University Graduate School of Medicine, Okayama, Japan.
Masatoshi EtoDepartment of Urology, Graduate School of Medical Sciences, University of Kyushu, Fukuoka, Japan.
Shigetaka SuekaneDepartment of Urology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, 830-0011, Japan.
Tetsuro SasadaKanagawa Cancer Center Research Institute, Kanagawa, Japan.
Shigeki ShichijoCanver Vaccine Center, Kurume University School of Medicine, 67 Asahi-machi, Kurume, 830-0011, Japan.
Akira YamadaCancer Vaccines, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan.
Tatsuyuki KakumaBiostatistics Center, Kurume University School of Medicine, Kurume, Japan.
Kyogo ItohCanver Vaccine Center, Kurume University School of Medicine, 67 Asahi-machi, Kurume, 830-0011, Japan.
Kurume University · JPDokkyo Medical University Saitama Medical Center · JPHirosaki University · JPJikei University School of Medicine · JPKagoshima University · JPKanagawa Prefectural Hospital Organization · JPKindai University · JPKitasato University · JPKyushu University · JPOkayama University · JP

Funding

Ministry of Health, Labour and Welfare ID 2014110358
6 · The paper itself

Abstract

A novel cancer vaccine consisting of 20 mixed peptides (KRM-20) was designed to induce cytotoxic T lymphocytes (CTL) against twelve different tumor-associated antigens. The aim of this phase II trial was to examine whether KRM-20 in combination with docetaxel and dexamethasone enhances the antitumor effects in patients with castration-resistant prostate cancer (CRPC). In this double-blind, placebo-controlled, randomized phase II study, we enrolled chemotherapy-naïve patients with CRPC from ten medical centers in Japan. Eligible patients were randomly assigned 1:1 centrally to receive either KRM-20 combined with docetaxel and dexamethasone (n = 25) or placebo with docetaxel and dexamethasone (n = 26). The primary endpoint was the difference in prostate-specific antigen (PSA) decline between each treatment. The rates of > 50% PSA decline in the two arms were similar (56.5% versus 53.8%; P = 0.851). Human leukocyte antigen (HLA)-matched peptide-specific immunoglobulin G (P = 0.018) and CTL (P = 0.007) responses in the KRM-20 arm significantly increased after treatment. The addition of KRM-20 did not increase toxicity. There were no between-group differences in progression-free or overall survival (OS). The addition of KRM-20 was safe, and similar PSA decline and HLA-matched peptide-specific CTL and IgG responses increased in combination with docetaxel and dexamethasone in CRPC patients. Subgroup analysis suggested that this treatment is favorable for CRPC patients with ≥ 26% lymphocytes or PSA levels of < 11.2 ng/ml, but further clinical trials comparing OS are required.

Indexed as

Administration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCancer VaccinesCombined Modality TherapyDexamethasoneDocetaxelDouble-Blind MethodDrug Administration ScheduleHumansInfusions, IntravenousInjections, SubcutaneousKallikreinsMaleCancer VaccinesDexamethasoneDocetaxelKallikreinsKLK3 protein, humanProstate-Specific AntigenVaccines, SubunitDocetaxelImmunotherapyMultiple-peptide vaccinePhase II trialProstate cancer

Identifiers

PMID32025848
PMCPMC7183507
OpenAlexW3004789363

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.