Evidence map›Paper›PMID 23839751›Full record

Trial reportJAMA2013

Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy: a randomized trial.

Maarten C Bosland, Ikuko Kato, Anne Zeleniuch-Jacquotte, Joanne Schmoll, Erika Enk Rueter, Jonathan Melamed, Max Xiangtian Kong, Virgilia Macias, Andre Kajdacsy-Balla, L H Lumey and 10 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00765479 (Randomized Placebo-Controlled Adjuvant Study of Prevention of Prostate Cancer Recurrence After Radical Prostatectomy by Soy Protein Isolate), which is not on this map. Cited by 42 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 3 pooled it
4.9field-weighted citation impact, top 5% 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.

NCT00765479 phase2 / phase3completednot on this map

Randomized Placebo-Controlled Adjuvant Study of Prevention of Prostate Cancer Recurrence After Radical Prostatectomy by Soy Protein Isolate

TypeinterventionalSponsorUniversity of Illinois at ChicagoRan2006 to 2013Enrolled284ConditionsProstate CancerArmssoy protein isolate, placebo
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 74 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 4 institutions in 1 country.

Maarten C BoslandDepartment of Pathology, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA. boslandm@uic.edu
Ikuko Kato
Anne Zeleniuch-Jacquotte
Joanne Schmoll
Erika Enk Rueter
Jonathan Melamed
Max Xiangtian Kong
Virgilia Macias
Andre Kajdacsy-Balla
L H Lumey
Hui Xie
Weihua Gao
Paul Walden
Herbert Lepor
Samir S Taneja
Carla Randolph
Michael J Schlicht
Hiroko Meserve-Watanabe
Ryan J Deaton
Joanne A Davies
New York University · USUniversity of Illinois Chicago · USColumbia University · USWayne State University · US

Funding

Vaccine FacilityP30CA016087 · NCI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ANIRBAN MAITRA · 1985 to 2026
$83.1M
Center for Clinical and Translational ScienceUL1TR000050 · NCATS · UNIVERSITY OF ILLINOIS AT CHICAGO · PI AZAR, DIMITRI T, MERMELSTEIN, ROBIN J. · 2012 to 2014
$9.8M
ADJUVANT TRIAL WITH SOY AFTER RADICAL PROSTATECTOMYR01CA116195 · NCI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI BOSLAND, MAARTEN C · 2006 to 2010
$1.6M
PROSTATE CANCER CHEMOPREVENTION CLINICAL TRIALSU01CA072290 · NCI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BOSLAND, MAARTEN C · 1997 to 2001
$750k
NCATS NIH HHS UL1 TR000050NCI NIH HHS P30 CA016087NCI NIH HHS P50 CA16087NCI NIH HHS R01 CA116195NCI NIH HHS R01 CA166195NCI NIH HHS U01 CA072290
6 · The paper itself

Abstract

importanceSoy consumption has been suggested to reduce risk or recurrence of prostate cancer, but this has not been tested in a randomized trial with prostate cancer as the end point.

objectiveTo determine whether daily consumption of a soy protein isolate supplement for 2 years reduces the rate of biochemical recurrence of prostate cancer after radical prostatectomy or delays such recurrence. DESIGN, SETTING, AND

participantsRandomized, double-blind trial conducted from July 1997 to May 2010 at 7 US centers comparing daily consumption of a soy protein supplement vs placebo in 177 men at high risk of recurrence after radical prostatectomy for prostate cancer. Supplement intervention was started within 4 months after surgery and continued for up to 2 years, with prostate-specific antigen (PSA) measurements made at 2-month intervals in the first year and every 3 months thereafter.

interventionParticipants were randomized to receive a daily serving of a beverage powder containing 20 g of protein in the form of either soy protein isolate (n=87) or, as placebo, calcium caseinate (n=90). MAIN OUTCOMES AND MEASURES: Biochemical recurrence rate of prostate cancer (defined as development of a PSA level of ≥0.07 ng/mL) over the first 2 years following randomization and time to recurrence.

resultsThe trial was stopped early for lack of treatment effects at a planned interim analysis with 81 evaluable participants in the intervention group and 78 in the placebo group. Overall, 28.3% of participants developed biochemical recurrence within 2 years of entering the trial (close to the a priori predicted recurrence rate of 30%). Among these, 22 (27.2%) occurred in the intervention group and 23 (29.5%) in the placebo group. The resulting hazard ratio for active treatment was 0.96 (95% CI, 0.53-1.72; log-rank P = .89). Adherence was greater than 90% and there were no apparent adverse events related to supplementation. CONCLUSION AND RELEVANCE: Daily consumption of a beverage powder supplement containing soy protein isolate for 2 years following radical prostatectomy did not reduce biochemical recurrence of prostate cancer in men at high risk of PSA failure.

trial registrationclinicaltrials.gov Identifier: NCT00765479.

Indexed as

Dietary SupplementsAgedBeveragesDouble-Blind MethodFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalProstatectomyProstate-Specific AntigenProstatic NeoplasmsRiskSoybean ProteinsTreatment OutcomeProstate-Specific AntigenSoybean Proteins

Identifiers

PMID23839751
PMCPMC3921119
OpenAlexW1966238704

What OpenQuestion holds

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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.