Evidence map›Paper›PMID 35260100›Full record

ArticleBMC cancer2022

PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial.

Cynthia Ménard, Sympascho Young, Katherine Zukotynski, Robert J Hamilton, François Bénard, Steven Yip, Christopher McCabe, Fred Saad, Michael Brundage, Roy Nitulescu and 1 more

Registry-linked trialAbstract readClinical Trial ProtocolMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04557501 (PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT04557501 phase3active not recruitingnot on this map

PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer

TypeinterventionalSponsorCentre hospitalier de l'Université de Montréal (CHUM)Ran2021 to 2029Enrolled800ConditionsProstate CancerArmsPSMA PET/CT guided intensification of therapy, Control Arm
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Prognostic significance of a negative PSMA PET/CT in biochemical recurrence of prostate cancer.Cancer imaging : the official publication of the International Cancer Imaging Society · 2024
    Observational
  9. Review
  10. Article
  11. Article
  12. PSMA-PET in Canada: More questions than answers.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2023
    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

11 authors.

Cynthia MénardDepartment of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada. cynthia.menard@umontreal.ca.
Sympascho YoungDepartment of Oncology, London Health Sciences Centre, Western University, London, ON, Canada.
Katherine ZukotynskiDepartments of Medicine and Radiology, McMaster University, Hamilton, ON, Canada.
Robert J HamiltonDepartment of Surgery (Urology), Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
François BénardDepartment of Radiology, British Columbia Cancer Agency, University of British Columbia, Vancouver, BC, Canada.
Steven YipDepartment of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.
Christopher McCabeInstitute for Health Economics, University of Alberta, Edmonton, AB, Canada.
Fred SaadDepartment of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
Michael BrundageDepartment of Oncology, Kingston Regional Cancer Centre, Queen's University, Kingston, ON, Canada.
Roy NitulescuDepartment of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
Glenn BaumanDepartment of Oncology, London Health Sciences Centre, Western University, London, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPositron emission tomography targeting the prostate specific membrane antigen (PSMA PET/CT) has demonstrated unparalleled performance as a staging examination for prostate cancer resulting in substantial changes in management. However, the impact of altered management on patient outcomes is largely unknown. This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer.

methodsThis pan-Canadian phase III randomized controlled trial will enroll 776 men with either untreated high risk prostate cancer (CAPRA score 6-10 or stage cN1) or biochemically recurrent prostate cancer post radical prostatectomy (PSA > 0.1 ng/mL). Patients will be randomized 1:1 to either receive conventional imaging or conventional plus PSMA PET imaging, with intensification of radiotherapy or surgery to newly identified disease sites. The primary endpoint is failure free survival at 5 years. Secondary endpoints include rates of adverse events, time to next-line therapy, as well as impact on health-related quality of life and cost effectiveness as measured by incremental cost per Quality Adjusted Life Years gained. DISCUSSION: This study will help create level 1 evidence needed to demonstrate whether or not intensification of radiotherapy or surgery based on PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective.

trial registrationThis trial was prospectively registered in ClinicalTrials.gov as NCT04557501 on September 21, 2020.

Indexed as

Positron Emission Tomography Computed TomographyAdultAntigens, NeoplasmCanadaClinical Trials, Phase III as TopicEquivalence Trials as TopicFluorine RadioisotopesGPI-Linked ProteinsHumansIntention to Treat AnalysisMaleNeoplasm ProteinsNeoplasm Recurrence, LocalNeoplasm StagingPragmatic Clinical Trials as TopicProspective StudiesAntigens, NeoplasmFluorine-18Fluorine RadioisotopesGPI-Linked ProteinsNeoplasm ProteinsPSCA protein, humanRadiopharmaceuticalsCost-effectiveness analysisFailure free survivalOverall survivalPhase III clinical trialProstate cancerPSMA PETRadiotherapySuperiority

Identifiers

PMID35260100
PMCPMC8902723

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.