Evidence map›Paper›PMID 33999161›Full record

ArticleJAMA network open2021

Association of Increased Prostate-Specific Antigen Levels After Treatment and Mortality in Men With Locally Advanced vs Localized Prostate Cancer: A Secondary Analysis of 2 Randomized Clinical Trials.

Martin T King, Ming-Hui Chen, Laurence Collette, Anouk Neven, Michel Bolla, Anthony V D'Amico

2 registry-linked trialsAbstract readComparative StudyMulticenter Study
In one paragraph

Article in JAMA network open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT00003026 phase3completednot on this map

Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study

TypeinterventionalSponsorEuropean Organisation for Research and Treatment of Cancer - EORTCRan1997Enrolled966ConditionsProstate CancerArmsbicalutamide, flutamide, triptorelin, radiation therapy
NCT00116220 phase3completednot on this map

A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer

TypeinterventionalSponsorDana-Farber Cancer InstituteRan1995 to 2015Enrolled206ConditionsProstate CancerArmsFlutamide (Eulexin) and Lupron or Zoladex, External Beam Radiotherapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Observational
  3. 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

6 authors.

Martin T KingDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.
Ming-Hui ChenDepartment of Statistics, University of Connecticut, Storrs.
Laurence ColletteEuropean Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
Anouk NevenEuropean Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
Michel BollaDepartment of Radiation Oncology, Grenoble University Hospital, Grenoble, France.
Anthony V D'AmicoDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Increased prostate-specific antigen (PSA) levels after treatment (PSA failure) may have different associations with outcomes for men with locally advanced vs localized prostate cancer. Objective: To evaluate whether the association between PSA failure and death may be different in locally advanced vs localized prostate cancer. Design, Setting, and Participants: This multicenter cohort study included patients from 2 randomized clinical trials. The Dana-Farber Cancer Institute (DFCI) 95-096 trial randomized 206 men with localized prostate cancer from December 1, 1995, to April 15, 2001, whereas the European Organisation for Research and Treatment of Cancer (EORTC) 22961 trial randomized 970 men with locally advanced prostate cancer from October 30, 1997, to May 1, 2002. Data were analyzed from January 1, 2020, to October 31, 2020. Interventions: The DFCI 95-096 trial randomized men to 0 vs 6 months of androgen deprivation therapy (ADT) with external beam radiotherapy; the EORTC 22961 trial randomized men to 6 vs 36 months of ADT with external beam radiotherapy. Main Outcomes and Measures: For each trial, the PSA doubling time (time to doubling of PSA levels) associated with PSA failure was evaluated. The risk of all-cause mortality associated with PSA failure (nadir plus 2 definition) was evaluated after adjustment of baseline covariates and treatment. Results: This analysis included a total of 1173 men (206 from DFCI 95-096 and 967 with available tumor stage from EORTC 22961; median age, 70.0 [interquartile range (IQR), 65.0-74.0 years). For DFCI 95-096, 161 men died (30 [18.6%] due to prostate cancer) at a median follow-up of 18.2 (IQR, 17.3-18.8) years. Among the 108 men with PSA failure, the median PSA doubling time was 13.0 (IQR, 7.4-31.1) months. For EORTC 22961, 230 men died (75 [32.6%] due to prostate cancer) at a median follow-up of 6.4 (IQR, 6.3-6.6) years. Among 290 men who experienced PSA failure, the median PSA doubling time was 5.0 (IQR, 2.9-8.9) months. Compared with DFCI 95-096, PSA failure was associated with a higher risk of all-cause mortality in EORTC 22961 (adjusted hazard ratios, 3.98 [95% CI, 2.92-5.44]; P < .001 vs 1.51 [95% CI, 1.03-2.23]; P = .04). Conclusions and Relevance: The association of PSA failure with outcomes may differ between locally advanced and localized prostate cancer. This finding supports the study of treatment intensification with the use of novel antiandrogen agents in addition to ADT at the time of PSA failure after treatment for locally advanced disease. Trial Registration: ClinicalTrials.gov Identifiers: NCT00116220 and NCT00003026.

Indexed as

AgedAndrogen AntagonistsAntineoplastic Agents, HormonalBelgiumBiomarkers, TumorBostonCohort StudiesHumansMaleNeoplasm MetastasisProstate-Specific AntigenProstatic NeoplasmsRandomized Controlled Trials as TopicTime FactorsAndrogen AntagonistsAntineoplastic Agents, HormonalBiomarkers, TumorProstate-Specific Antigen

Identifiers

PMID33999161
PMCPMC8129819

What OpenQuestion holds

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LicenceCC BY
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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.