Evidence map›Paper›PMID 19758646›Full record

Trial reportThe Journal of urology2009

Lack of an effect of high dose isoflavones in men with prostate cancer undergoing androgen deprivation therapy.

Preetika Sharma, Amy Wisniewski, Milena Braga-Basaria, Xiaoqiang Xu, Mary Yep, Samuel Denmeade, Adrian S Dobs, Theodore DeWeese, Michael Carducci, Shehzad Basaria

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of urology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06957691 (Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy), which is not on this map. Cited by 20 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 7 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT06957691 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)

TypeinterventionalSponsorShehzad Basaria, M.D.Ran2026 to 2028Enrolled60ConditionsProstate Cancer, Prostate Cancer (Adenocarcinoma), Prostate Cancer Metastatic Disease, Prostate Cancer RecurrentArmsfezolinetant - reference formulation, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 7 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
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  4. The effectiveness of lifestyle interventions to reduce side effects of androgen deprivation therapy for men with prostate cancer: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2020
    Pooled it
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  7. Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2017
    Guideline
  8. Trial
  9. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013
    Trial
  10. [Integration of complementary medicine in uro-oncology].Urologie (Heidelberg, Germany) · 2025
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Preetika SharmaGeorgetown University, Washington, DC, USA.
Amy Wisniewski
Milena Braga-Basaria
Xiaoqiang Xu
Mary Yep
Samuel Denmeade
Adrian S Dobs
Theodore DeWeese
Michael Carducci
Shehzad Basaria
Johns Hopkins Medicine · USBoston University · USSidney Kimmel Comprehensive Cancer Center · USGeorgetown University · USJohns Hopkins University · USUniversity of Oklahoma · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

purposeThe profound hypogonadism due to androgen deprivation therapy for prostate cancer results in complications such as sexual dysfunction, poor quality of life, vasomotor symptoms and altered cognition. Since estrogen is associated with cardiovascular risks, phytoestrogens are being increasingly evaluated as a potential treatment for these adverse effects. We evaluated the effects of high dose isoflavones, equivalent to that consumed by Asian populations, on the aforementioned consequences of androgen deprivation therapy. MATERIALS AND

methodsA total of 33 men undergoing androgen deprivation therapy for prostate cancer were enrolled in this randomized, double-blind, placebo controlled, 12-week pilot trial. Participants were randomly assigned to receive 20 gm soy protein containing 160 mg total isoflavones (17) vs taste matched placebo, that is 20 gm whole milk protein (16). The study was performed at a tertiary care center in the United States.

resultsAt baseline the groups were well matched in demographic parameters, sleep quality, cognition and overall quality of life. However, men in the isoflavone group had a higher baseline prevalence of hot flashes and poor intercourse satisfaction compared to those on placebo. At 12 weeks there were no significant differences between the 2 groups in any outcome measure.

conclusionsThis pilot study of high dose isoflavones in androgen deprived men showed no significant improvement in cognition, vasomotor symptoms or any other aspect of quality of life measures compared to placebo. Future studies should use variable doses of isoflavones for a longer period before ruling out beneficial isoflavone effects in this population.

Indexed as

AgedAndrogen AntagonistsDouble-Blind MethodHumansIsoflavonesMalePilot ProjectsProstatic NeoplasmsAndrogen AntagonistsIsoflavones

Identifiers

PMID19758646
PMCPMC3089061
OpenAlexW2131111709

What OpenQuestion holds

Textmetadata
LicenceTDM
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.