Evidence map›Paper›PMID 31429205›Full record

Trial reportCancer medicine2019

Phase I trial of TAK-385 in hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer.

Hiroyoshi Suzuki, Hiroji Uemura, Atsushi Mizokami, Narihiko Hayashi, Yasuhide Miyoshi, Satoshi Nagamori, Yutaka Enomoto, Hideyuki Akaza, Takayuki Asato, Tadayuki Kitagawa and 1 more

Abstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Hormonal Therapy for Prostate Cancer.Endocrine reviews · 2021
    Review
  16. Article
  17. Review
  18. Review
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

11 authors.

Hiroyoshi SuzukiDepartment of Urology, Toho University Sakura Medical Center, Chiba, Japan.
Hiroji UemuraDepartment of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan.
Atsushi MizokamiDepartment of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.
Narihiko HayashiDepartment of Urology, Public University Corporation Yokohama City University Hospital, Yokohama, Japan.
Yasuhide MiyoshiDepartment of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan.
Satoshi NagamoriDepartment of Urology, Incorporated Administrative Agency National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Yutaka EnomotoDepartment of Urology, Mitsui Memorial Hospital, Tokyo, Japan.
Hideyuki AkazaDepartment of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies/Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan.
Takayuki AsatoOncology Clinical Research Department, Oncology Therapeutic Area Unit for Japan and Asia, Takeda Pharmaceutical Company Limited, Osaka, Japan.ORCID 0000-0003-1307-1505
Tadayuki KitagawaJapan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Kazuhiro SuzukiDepartment of Urology, Graduate School of Medicine, National University Corporation Gunma University, Maebashi, Japan.

Funding

Takeda Pharmaceutical Company
6 · The paper itself

Abstract

This open-label, phase I dose-finding study evaluated the gonadotropin-releasing hormone antagonist, TAK-385, in Japanese patients with nonmetastatic prostate cancer. In a two-part design, patients received daily oral TAK-385 at doses of 320 (loading, day 1)/80 (maintenance, day 2 and thereafter), 320/120, 320/160, or 360/120 mg for 28 days in a dose-escalation phase (part A, n = 13), and at 320/80 or 320/120 mg for up to 96 weeks in a randomized expansion phase (part B, n = 30). Primary endpoint in both parts was safety, including dose-limiting toxicity in part A. Secondary endpoints included pharmacokinetics, pharmacodynamics, and prostate-specific antigen concentration. Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent. No dose-limiting toxicities were observed (part A). In 12 evaluable patients (part A), TAK-385 was rapidly absorbed after a single loading dose; on day 28 (maintenance dose), median steady-state T

Indexed as

Administration, OralAgedAged, 80 and overAntineoplastic AgentsAsian PeopleHumansKallikreinsMalePhenylurea CompoundsProstate-Specific AntigenProstatic NeoplasmsPyrimidinonesReceptors, LHRHTestosteroneAntineoplastic AgentsKallikreinsKLK3 protein, humanPhenylurea CompoundsProstate-Specific AntigenPyrimidinonesReceptors, LHRHrelugolixTestosteronehormone therapyprostate cancer

Identifiers

PMID31429205
PMCPMC6792482

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.