Evidence map›Paper›PMID 35015566›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.

Heiko Schöder, Thomas A Hope, Michael Knopp, William K Kelly, Jeff M Michalski, Seth P Lerner, Abdul Tawab-Amiri, Bhupinder S Mann, Daniel W Lin, Evan Y Yu and 5 more

Abstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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

12 citing papers in PubMed.

  1. Review
  2. National Cancer Institute's Working Group on Biochemically Recurrent Prostate Cancer: Clinical Trial Design Considerations.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Impact of a Novel Molecular Imaging Modality, Prostate-Specific Membrane Antigen Positron Emission Tomography, on the Management of Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Article
  10. Article
  11. Article
  12. 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

15 authors.

Heiko SchöderMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5170-4185
Thomas A HopeUniversity of California, San Francisco, CA.ORCID 0000-0002-2228-5823
Michael KnoppThe Ohio State University, Columbus, OH.ORCID 0000-0001-9543-2962
William K KellyThomas Jefferson University, Philadelphia, PA.
Jeff M MichalskiWashington University School of Medicine, St Louis, MO.ORCID 0000-0003-0563-3766
Seth P LernerBaylor College of Medicine, Houston, TX.ORCID 0000-0002-6379-2581
Abdul Tawab-AmiriCoordinating Center for Clinical Trials, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Bhupinder S MannCancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Daniel W LinUniversity of Washington, Seattle, WA.ORCID 0000-0002-2135-1534
Evan Y YuUniversity of Washington, Seattle, WA.ORCID 0000-0002-1510-8044
Ronald C ChenUniversity of Kansas Medical Center, Kansas City, KS.
Gillian C BeachEmmes Company, New York, NY.ORCID 0000-0001-9819-4365
Steven A ReevesCoordinating Center for Clinical Trials, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Members of the Working Group
Lalitha K ShankarCancer Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAs prostate-specific membrane antigen (PSMA) positron emission tomography (PET) becomes increasingly available in the United States, the greater sensitivity of the technology in comparison to conventional imaging poses challenges for clinical trials. The NCI Clinical Imaging Steering Committee (CISC) PSMA PET Working Group was convened to coordinate the identification of these challenges in various clinical scenarios and to develop consensus recommendations on how best to integrate PSMA PET into ongoing and upcoming National Clinical Trials Network (NCTN) trials.

methodsNCI CISC and NCI Genitourinary Steering Committee members and leadership nominated clinicians, biostatisticians, patient advocates, and other imaging experts for inclusion in the PSMA PET Working Group. From April to July 2021, the working group met independently and in conjunction with the CISC to frame challenges, including stage migration, response assessment, trial logistics, and statistical challenges, and to discuss proposed solutions. An anonymous, open-ended survey was distributed to members to collect feedback on challenges faced. Representatives from each NCTN group were invited to present an overview of affected trials. From these discussions, the consensus document was developed and circulated for the inclusion of multiple rounds of feedback from both the Working Group and CISC.

resultsThe current consensus document outlines the key challenges for clinical prostate cancer trials resulting from the increasing availability of PSMA PET. We discuss implications for patient selection and definition of end points and provide guidance and potential solutions for different clinical scenarios, particularly with regard to best practices in defining eligibility criteria and outcome measures. RECOMMENDATIONS: This article provides guidance regarding clinical trial design and conduct, and the interpretation of trial results.

Indexed as

Clinical Trials as TopicProstatic NeoplasmsHumansMalePositron-Emission Tomography

Identifiers

PMID35015566
PMCPMC9851697

What OpenQuestion holds

Textmetadata
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.