Evidence map›Paper›PMID 18423743›Full record

GuidelineThe Journal of urology2008

Prostate Specific Antigen Working Group guidelines on prostate specific antigen doubling time.

Philip M Arlen, Fernando Bianco, William L Dahut, Anthony D'Amico, William D Figg, Stephen J Freedland, James L Gulley, Philip W Kantoff, Michael W Kattan, Andrew Lee and 3 more

Registry-linked trialAbstract readPractice Guideline
In one paragraph

Guideline in The Journal of urology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03103724 (A Phase II Study Evaluating the Efficacy of Enzalutamide and the Role of ARv7 in Metastatic Castration Resistant Prostate Cancer), which is not on this map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 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.

NCT03103724 phase2completednot on this mapstarted 2017, after this paper: background citation

A Phase II Study Evaluating the Efficacy of Enzalutamide and the Role of ARv7 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients With Visceral Disease.

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2017 to 2021Enrolled68ConditionsCarcinoma ProstateArmsXtandi
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Philip M ArlenMedical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892, USA.
Fernando Bianco
William L Dahut
Anthony D'Amico
William D Figg
Stephen J Freedland
James L Gulley
Philip W Kantoff
Michael W Kattan
Andrew Lee
Meredith M Regan
Oliver Sartor
Prostate Specific Antigen Working Group

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Clinical trials employing cancer vaccine combination therapiesZIABC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2022
$9.6M
The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZIASC010098 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2009 to 2022
$7.6M
Vaccine Clinical TrialsZ01BC010662 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ARLEN, PHILIP M · 2005 to 2008
$1.7M
SNPs /Polymorphisms in Development of Prostate CancerZ01BC010453 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2002 to 2008
$938k
Development of Drugs That Target Prostate CancerZ01BC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2003 to 2008
$463k
Intramural NIH HHS Z01 BC010453
6 · The paper itself

Abstract

purposeProstate specific antigen is a glycoprotein found almost exclusively in normal and neoplastic prostate cells. Prostate specific antigen doubling time, or the change in prostate specific antigen over time, has emerged as a useful predictive marker for assessing disease outcome in patients with prostate cancer. It is important to agree on definitions and values for the calculation of prostate specific antigen doubling time, and to develop a common approach to outcome analysis and reporting. MATERIALS AND

methodsIn September 2006 a conference was held at the National Cancer Institute in Bethesda, Maryland to define these parameters and develop guidelines for their use.

resultsThe Prostate Specific Antigen Working Group defined criteria regarding prostate specific antigen doubling time including the calculation of prostate specific antigen doubling time, evidence to support prostate specific antigen doubling time as a predictive factor in the setting of biochemical recurrence and the use of prostate specific antigen doubling time as a stratification factor in clinical trials.

conclusionsWe propose that investigators calculate prostate specific antigen doubling time before enrolling patients in clinical studies and calculate it as an additional measurement of therapeutic activity. We believe we have developed practical guidelines for the calculation of prostate specific antigen doubling time and its use as a measurement of prognosis and outcome. Furthermore, the use of common standards for prostate specific antigen doubling time in clinical trials is important as we determine which treatments should progress to randomized trials in which "hard" end points such as survival will be used.

Indexed as

BiomarkersHumansMaleProstate-Specific AntigenProstatic NeoplasmsTime FactorsBiomarkersProstate-Specific Antigen

Identifiers

PMID18423743
PMCPMC2667701

What OpenQuestion holds

Textmetadata
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.