Evidence map›Paper›PMID 30300367›Full record

Trial reportPloS one2018

The effect of 3-month finasteride challenge on biomarkers for predicting cancer outcome on biopsy: Results of a randomized trial.

Javier Hernandez, Jonathan Gelfond, Martin Goros, Michael A Liss, Yuanyuan Liang, Donna Ankerst, Ian M Thompson, Robin J Leach

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01296672 (Improving Prostate Biopsy Efficiency), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 29% 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.

NCT01296672 phase4completednot on this map

Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

TypeinterventionalSponsorThe University of Texas Health Science Center at San AntonioRan2011 to 2017Enrolled383ConditionsProstate CancerArmsFinasteride, Placebo
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

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

8 authors at 2 institutions in 2 countries.

Javier HernandezDepartment of Urology, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.
Jonathan GelfondDepartment of Epidemiology and Biostatistics, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.
Martin GorosDepartment of Epidemiology and Biostatistics, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.
Michael A LissDepartment of Urology, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.
Yuanyuan LiangDepartment of Urology, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.
Donna AnkerstDepartment of Urology, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.
Ian M ThompsonDepartment of Urology, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.
Robin J LeachDepartment of Urology, The University of Texas Health San Antonio, San Antonio, Texas, United States of America.ORCID 0000-0002-3201-5579
The University of Texas Health Science Center at San Antonio · USUniversity of Maryland, Baltimore · US

Funding

TISSUE CULTURE---COREP30CA054174 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Robin Jean Leach · 1991 to 2026
$59.1M
San Antonio OAIC - Research Education Component (REC)P30AG044271 · NIA · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Adam Salmon · 2015 to 2026
$14.1M
Bayesian Approaches to Model Selection for Survival DataR01GM070335 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI IBRAHIM, JOSEPH G · 2003 to 2019
$4.0M
Dynamic, multi-cohort prediction modeling of prostate biopsy outcomeR01CA179115 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI ANKERST, DONNA PAULER, VICKERS, ANDREW J · 2014 to 2018
$2.3M
Improving prostate biopsy efficiency: The finasteride challenge testR01CA138627 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI HERNANDEZ, JAVIER, LEACH, ROBIN JEAN · 2010 to 2014
$2.1M
NCI NIH HHS P30 CA054174NCI NIH HHS R01 CA138627NCI NIH HHS R01 CA179115NIA NIH HHS P30 AG044271NIGMS NIH HHS R01 GM070335
6 · The paper itself

Abstract

backgroundFinasteride, a 5-alpha reductase inhibitor may have effects on biomarkers such as prostate-specific antigen (PSA) that could be leveraged to improve screening.

objectiveTo determine the predictive characteristics of biomarkers for prostate cancer for cancer on biopsy following 3 months of finasteride use compared with placebo. DESIGN, SETTING AND

participants383 men from multiple clinical sites with intermediate prostate cancer risk, without history of prostate cancer, were randomly allocated in a double-blinded manner, 4:1, to receive either finasteride or placebo for 90 days at which time a prostate biopsy was performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcomes were associations of biomarkers with prostate cancer that were tested using multiple logistic regression and area under the receiver operating curves (AUC). Biomarkers for PCA risk (PCA3, TMPRSS2:ERG (T2:ERG) gene product, and PSA) were measured at baseline and at biopsy in a blinded fashion to assess the predictive performance of baseline levels, 90-day levels, and measures of change relative to standard predictors. RESULTS AND LIMITATIONS: A total of 292 (233 finasteride; 59 placebo) randomized patients underwent biopsy and were analyzed. On finasteride, baseline and 90-day measures of PCA3 and T2:ERG had similar moderate discrimination capacity with AUCs 62 to 65% (p-values < 0.001 and 0.001, respectively), but their rates of change had no discrimination ability (AUC 51%, (95% CI 43 to 60% p = 0.72) and 48% (95% CI 44 to 60%, p = 0.62), respectively).) Relative to baseline, the 90-day PCA3 and PSA decreased in the finasteride group by 25% and 50%, respectively (both p<0.001). T2:ERG had a smaller, non-significant change post finasteride treatment (p = 0.08).

conclusionsShort-term finasteride therapy did not improve performance of the most commonly-employed prostate cancer biomarkers. Threshold values for new biomarkers of prostate cancer should be interpreted with caution in patients receiving finasteride until formal validation of test performance in these patients is conducted. PATIENT SUMMARY: Three months of finasteride treatment did not increase the accuracy for predicting the outcome on prostate biopsy but did have a significant effect on biomarker values. Adjustments to thresholds for biopsy for men on finasteride are proposed.

trial registrationClinicalTrials.gov, NCT01296672.

Indexed as

5-alpha Reductase InhibitorsBiomarkers, TumorFinasterideProstateProstatic NeoplasmsAdultAgedAged, 80 and overAntigens, NeoplasmBiopsyDouble-Blind MethodHumansMaleMiddle AgedOncogene Proteins, FusionProstate-Specific Antigen5-alpha Reductase InhibitorsAntigens, NeoplasmBiomarkers, TumorFinasterideOncogene Proteins, Fusionprostate cancer antigen 3, humanProstate-Specific AntigenTMPRSS2-ERG fusion protein, human

Identifiers

PMID30300367
PMCPMC6177134
OpenAlexW2896920574

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.