Evidence map›Paper›PMID 31502940›Full record

ArticleThe Journal of urology2020

Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.

Chana Weinstock, Daniel Suzman, Paul Kluetz, John Baxley, Charles Viviano, Amna Ibrahim, Jonathan Jarow, Raejshwari Sridhara, Ke Liu, Peter Carroll and 16 more

Erratum issuedOpen access · greenAbstract read
In one paragraph

Article in The Journal of urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.6field-weighted citation impact, top 15% 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

5 citing papers in PubMed, 13 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 13 institutions in 1 country.

Chana WeinstockUnited States Food and Drug Administration, Silver Spring, Maryland.
Daniel SuzmanUnited States Food and Drug Administration, Silver Spring, Maryland.
Paul KluetzUnited States Food and Drug Administration, Silver Spring, Maryland.
John BaxleyUnited States Food and Drug Administration, Silver Spring, Maryland.
Charles VivianoUnited States Food and Drug Administration, Silver Spring, Maryland.
Amna IbrahimUnited States Food and Drug Administration, Silver Spring, Maryland.
Jonathan JarowUnited States Food and Drug Administration, Silver Spring, Maryland.
Raejshwari SridharaUnited States Food and Drug Administration, Silver Spring, Maryland.
Ke LiuUnited States Food and Drug Administration, Silver Spring, Maryland.
Peter CarrollUniversity of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, California.
Scott EggenerUniversity of Chicago Medicine, Chicago, Illinois.
Jim C HuWeill Cornell Medicine, New York, New York.
Maha HussainRobert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Martin KingDana Farber Cancer Institute, Harvard Medical Center, Boston, Massachusetts.
Eric KleinCleveland Clinic, Cleveland, Ohio.
Terry KungelMaine Coalition to Fight Prostate Cancer, Augusta, Maine.
Danil MakarovNew York University School of Medicine, New York, New York.
Peter A PintoNational Cancer Institute, Bethesda, Maryland.
Brian RiniCleveland Clinic, Cleveland, Ohio.
Mack RoachUniversity of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, California.
Howard SandlerCedars-Sinai Medical Center, Los Angeles, California.
Peter N SchlegelNew York Presbyterian/Weill Cornell Medical Center, New York, New York.
Daniel SongThe Johns Hopkins Medical Institutions, Baltimore, Maryland.
Kirsten GoldbergUnited States Food and Drug Administration, Silver Spring, Maryland.
Richard PazdurUnited States Food and Drug Administration, Silver Spring, Maryland.
Julia A BeaverUnited States Food and Drug Administration, Silver Spring, Maryland.
United States Food and Drug Administration · USCleveland Clinic · USCedars-Sinai Medical Center · USCornell University · USDana-Farber Cancer Institute · USJohns Hopkins University · USNational Cancer Institute · USNew York University · USNorthwestern University · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of California, San Francisco · USUniversity of Chicago · USWeill Cornell Medicine · US

Funding

Prostate SectionZIABC011081 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI PINTO, PETER · 2009 to 2025
$15.2M
Intramural NIH HHS ZIA BC011081
6 · The paper itself

Abstract

purposeThe following is a summary of discussion at a United States FDA (Food and Drug Administration) public workshop reviewing potential trial designs and end points to develop therapies to treat localized prostate cancer. MATERIALS AND

methodsThe workshop focused on the challenge that drug and device development to treat localized prostate cancer has been limited by the large trial sizes and lengthy timelines required to demonstrate an improvement in overall or metastasis-free survival and by the lack of agreed on alternative end points. Additionally, evolving treatment paradigms in the management of localized prostate cancer include the widespread use of active surveillance of patients with low and some intermediate risk prostate cancer, and the availability of advances in imaging and genomics.

resultsThe workshop addressed issues related to trial design in this setting. Attendees discussed several potential novel end points such as a delay of morbidity due to radiation or prostatectomy and pathological end points such as Gleason Grade Group upgrade.

conclusionsThe workshop provided an open forum for multiple stakeholder engagement to advance the development of effective treatment options for men with localized prostate cancer.

Indexed as

Clinical Trials as TopicResearch DesignUnited States Food and Drug AdministrationDiagnostic ImagingEducationEndpoint DeterminationGenomicsHumansMalePopulation SurveillanceProstatic NeoplasmsUnited StatesWatchful Waitingdrug developmentequipment designprostatic neoplasmsresearch designUnited States Food and Drug Administration

Identifiers

PMID31502940
PMCPMC8274949
OpenAlexW2972517647

What OpenQuestion holds

Textmetadata
LicenceTDM
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.