Evidence map›Paper›PMID 35280654›Full record

ArticleTranslational andrology and urology2022

ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD

Rohan Malek, Sheng-Tang Wu, Dennis Serrano, Tran Tho, Rainy Umbas, Jeremy Teoh, Bannakji Lojanapiwat, Teng Aik Ong, Weber Kam On, Sam Minh Thai and 3 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Translational andrology and urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03035032 (A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT03035032 phase4completednot on this map

A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)

TypeinterventionalSponsorAstellas Pharma Singapore Pte. Ltd.Ran2017 to 2019Enrolled107ConditionsProstate CancerArmsLeuprolide
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. 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

13 authors at 11 institutions in 9 countries.

Rohan MalekDepartment of Urology, Hospital Selayang, Selangor, Malaysia.
Sheng-Tang WuDivision of Urology, Department of Surgery, Tri-Service General Hospital, Taipei.
Dennis SerranoSection of Urology, Department of Surgery, Manila Doctors Hospital, Manila, Philippines.
Tran ThoChemotherapy Department, Ho Chi Minh City University Medical Centre, Ho Chi Minh City, Vietnam.
Rainy UmbasDepartment of Urology, Dr. Cipto Mangunkusumo Hospital, University of Indonesia, Jakarta, Indonesia.
Jeremy TeohS.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.
Bannakji LojanapiwatDepartment of Surgery, Chiang Mai University, Chiang Mai, Thailand.
Teng Aik OngUniversity of Malaya Medical Centre, Kuala Lumpur, Malaysia.
Weber Kam OnSingapore General Hospital, Singapore, Singapore.
Sam Minh ThaiUrology Department, Cho Ray Hospital, Ho Chi Minh City, Vietnam.
Janet KimMedical Affairs Statistics, Astellas Pharma Inc., Northbrook, IL, USA.
Rupesh PophaleDepartment of Oncology, Astellas Pharma Inc., Singapore, Singapore.
Edmund ChiongDepartment of Urology, National University Hospital, Department of Surgery, National University of Singapore, Singapore, Singapore.
Astellas Pharma (United States) · USChiang Mai University · THCho Ray Hospital · VNHospital Selayang · MYNational University Hospital · SGPhilippine General Hospital · PHRumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo · IDSingapore General Hospital · SGTri-Service General Hospital · TWUniversity Malaya Medical Centre · MYUniversity Medical Center HCMC · VN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD Methods: ELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD Results: In total, 106 patients were included in the safety analysis set (SAF). The most common treatment-emergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD Conclusions: In conclusion, the safety profile of ELIGARD Trial Registration: Clinical trial registration number NCT03035032.

Indexed as

Depot formulationleuprolide acetateprostate cancerprostate-specific antigen (PSA)

Identifiers

PMID35280654
PMCPMC8899139
OpenAlexW4211263964

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.