Evidence map›Paper›PMID 21575967›Full record

Trial reportThe Journal of urology2011

Dutasteride reduces prostate size and prostate specific antigen in older hypogonadal men with benign prostatic hyperplasia undergoing testosterone replacement therapy.

Stephanie T Page, Lianne Hirano, Janet Gilchriest, Manjiri Dighe, John K Amory, Brett T Marck, Alvin M Matsumoto

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

Trial report in The Journal of urology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00194675 (Testosterone Replacement and Dutasteride Effectiveness), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% 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.

NCT00194675 phase4completednot on this map

Testosterone Replacement and Dutasteride Effectiveness (TRADE)

TypeinterventionalSponsorUniversity of WashingtonRan2005 to 2010Enrolled53ConditionsHypogonadism, Benign Prostatic HyperplasiaArmsDutasteride, Testosterone gel, Placebo dutasteride
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Testosterone treatment of men with mild cognitive impairment and low testosterone levels.American journal of Alzheimer's disease and other dementias · 2015
    Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Review
  10. An update on male hypogonadism therapy.Expert opinion on pharmacotherapy · 2014
    Article
  11. Review
  12. Article
  13. Article
  14. Androgens and prostate disease.Asian journal of andrology
    Review
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

7 authors at 3 institutions in 1 country.

Stephanie T PageDepartment of Medicine, University of Washington, Seattle, Washington, USA. page@u.washington.edu
Lianne Hirano
Janet Gilchriest
Manjiri Dighe
John K Amory
Brett T Marck
Alvin M Matsumoto
University of Washington · USGeriatric Research Education and Clinical Center · USVA Puget Sound Health Care System · US

Funding

Dose-response relationships between circulating and intraprostatic androgens in mR01AG037603 · NIA · UNIVERSITY OF WASHINGTON · PI PAGE, STEPHANIE T · 2010 to 2014
$1.6M
Hormonal and molecular consequences of androgen replacement on the prostateK23AG027238 · NIA · UNIVERSITY OF WASHINGTON · PI PAGE, STEPHANIE T · 2006 to 2010
$634k
NIA NIH HHS K23 AG027238NIA NIH HHS R01 AG037603
6 · The paper itself

Abstract

purposeBenign prostatic hyperplasia and hypogonadism are common disorders in aging men. There is concern that androgen replacement in older men may increase prostate size and symptoms of benign prostatic hyperplasia. We examined whether combining dutasteride, which inhibits testosterone to dihydrotestosterone conversion, with testosterone treatment in older hypogonadal men with benign prostatic hyperplasia reduces androgenic stimulation of the prostate compared to testosterone alone. MATERIALS AND

methodsWe conducted a double-blind, placebo controlled trial of 53 men 51 to 82 years old with symptomatic benign prostatic hyperplasia, prostate volume 30 cc or greater and serum total testosterone less than 280 ng/dl (less than 9.7 nmol/l). Subjects were randomized to daily transdermal 1% T gel plus oral placebo or dutasteride for 6 months. Testosterone dosing was adjusted to a serum testosterone of 500 to 1,000 ng/dl. The primary outcomes were prostate volume measured by magnetic resonance imaging, serum prostate specific antigen and androgen levels.

resultsA total of 46 subjects completed all procedures. Serum testosterone increased similarly into the mid-normal range in both groups. Serum dihydrotestosterone increased in the testosterone only but decreased in the testosterone plus dutasteride group. In the testosterone plus dutasteride group prostate volume and prostate specific antigen (mean ± SEM) decreased 12% ± 2.5% and 35% ± 5%, respectively, compared to the testosterone only group in which prostate volume and prostate specific antigen increased 7.5% ± 3.3% and 19% ± 7% (p = 0.03 and p = 0.008), respectively, after 6 months of treatment. Prostate symptom scores improved in both groups.

conclusionsCombined treatment with testosterone plus dutasteride reduces prostate volume and prostate specific antigen compared to testosterone only. Coadministration of a 5α-reductase inhibitor with testosterone appears to spare the prostate from androgenic stimulation during testosterone replacement in older, hypogonadal men with symptomatic benign prostatic hyperplasia.

Indexed as

5-alpha Reductase InhibitorsAgedAged, 80 and overAndrogensAzasteroidsDouble-Blind MethodDrug Therapy, CombinationDutasterideHormone Replacement TherapyHumansHypogonadismMaleMiddle AgedOrgan SizeProstateProstate-Specific Antigen5-alpha Reductase InhibitorsAndrogensAzasteroidsDutasterideProstate-Specific AntigenTestosterone

Identifiers

PMID21575967
PMCPMC3353656
OpenAlexW2130335721

What OpenQuestion holds

Textmetadata
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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.