Evidence map›Paper›PMID 32112659›Full record

ArticleCancer science2020

Intratumoral and s.c. injection of inactivated hemagglutinating virus of Japan envelope (GEN0101) in metastatic castration-resistant prostate cancer.

Kazutoshi Fujita, Taigo Kato, Koji Hatano, Atsunari Kawashima, Takeshi Ujike, Motohide Uemura, Ryoichi Imamura, Koji Okihara, Osamu Ukimura, Tsuneharu Miki and 3 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.2field-weighted citation impact, top 13% 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

17 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. HVJ-E links Apolipoprotein d to antitumor effects.Journal for immunotherapy of cancer · 2025
    Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Oncolyic Virotherapy for Prostate Cancer: Lighting a Fire in Winter.International journal of molecular sciences · 2022
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
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

13 authors at 2 institutions in 1 country.

Kazutoshi FujitaDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.ORCID https://orcid.org/0000-0002-6774-7497
Taigo KatoDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.ORCID https://orcid.org/0000-0002-8681-1407
Koji HatanoDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.
Atsunari KawashimaDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.ORCID https://orcid.org/0000-0001-9369-4264
Takeshi UjikeDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.
Motohide UemuraDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.
Ryoichi ImamuraDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.
Koji OkiharaDepartment of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Osamu UkimuraDepartment of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Tsuneharu MikiDepartment of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Toshihiro NakajimaGenomIdea, Inc., Osaka, Japan.
Yasufumi KanedaDivision of Gene Therapy Science, Osaka University Graduate School of Medicine, Suita, Japan.
Norio NonomuraDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.
The University of Osaka · JPKyoto Prefectural University of Medicine · JP

Funding

Japan Science and Technology Agency
6 · The paper itself

Abstract

Inactivated hemagglutinating virus of Japan envelope (HVJ-E) has an antitumor effect and tumor immunity. We undertook an open-label, phase I, dose-escalation study in patients with castration-resistant prostate cancer (CRPC) to determine the safety and efficacy of intratumoral and s.c. injection of HVJ-E (GEN0101). Patients with CRPC, who were resistant to or unable to receive standard of care, were included. GEN0101 was injected directly into the prostate and s.c. in two 28-day treatment cycles. The primary end-points were to evaluate the safety and tolerability of GEN0101 and determine its recommended dose. The secondary end-points were to analyze the antitumor effect and tumor immunity. Three patients received 30 000 mNAU GEN0101 and 6 received 60 000 mNAU. There was no dose-limiting toxicity, and the recommended dose of GEN0101 was defined as 60 000 mNAU. Radiographically, 1 patient had stable disease and 2 had progressive disease in the low-dose group, whereas 5 patients had stable disease and 1 had progressive disease in the high-dose group. Three patients in the high-dose group showed reduction in lymph node metastasis. Prostate-specific antigen increase rates in the high-dose group were suppressed more than those in the low-dose group. Natural killer cell activity was enhanced in 2 patients of the low-dose group and in 5 patients in the high-dose group. In conclusion, intratumoral and s.c. injections of GEN0101 were well-tolerated and feasible to use. The study is registered with the UMIN Clinical Trials Registry (no. UMIN000017092).

Indexed as

Oncolytic VirotherapyAgedAntibodies, ViralDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmHumansInjectionsKiller Cells, NaturalMaleMiddle AgedProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantSafetySendai virusViral Envelope ProteinsAntibodies, ViralProstate-Specific AntigenViral Envelope Proteinsantitumor effectcastration-resistant prostate cancerNK cellphase I clinical studySendai virus

Identifiers

PMID32112659
PMCPMC7226216
OpenAlexW3008777844

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.