Evidence map›Paper›PMID 27172434›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2016

Stable Intraprostatic Dihydrotestosterone in Healthy Medically Castrate Men Treated With Exogenous Testosterone.

Arthi Thirumalai, Lori A Cooper, Katya B Rubinow, John K Amory, Daniel W Lin, Jonathan L Wright, Brett T Marck, Alvin M Matsumoto, Stephanie T Page

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01327495 (Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.5field-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.

NCT01327495 phase2 / phase3completednot on this map

Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)

TypeinterventionalSponsorUniversity of WashingtonRan2011 to 2014Enrolled62ConditionsHealthyArmsplacebo acyline, placebo gel, Testosterone 1% gel 1.25 g, Testosterone 1% gel 2.5 g, Testosterone 1% gel 5.0 g
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Androgens, aging, and prostate health.Reviews in endocrine & metabolic disorders · 2022
    Review
  8. Determination of Intraprostatic and Intratesticular Androgens.International journal of molecular sciences · 2021
    Review
  9. Review
  10. Article
  11. Circulating sex steroids coregulate adipose tissue immune cell populations in healthy men.American journal of physiology. Endocrinology and metabolism · 2017
    Article
  12. Androgen Signaling in Prostate Cancer.Cold Spring Harbor perspectives in medicine · 2017
    Review
  13. Article
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

9 authors at 2 institutions in 1 country.

Arthi ThirumalaiDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Lori A CooperDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Katya B RubinowDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
John K AmoryDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Daniel W LinDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Jonathan L WrightDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Brett T MarckDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Alvin M MatsumotoDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Stephanie T PageDepartment of Medicine (A.T., K.B.R., J.K.A., A.M.M., S.T.P.), University of Washington, Seattle, Washington 98195; Endocrinology (L.A.C.), The Polyclinic, Seattle, Washington 98122; Department of Urology (D.W.L., J.L.W.), University of Washington, Seattle, Washington 98195; Division of Public Health Sciences (D.W.L., J.L.W.), Fred Hutchinson Cancer Research Center, Seattle, Washington 98109; Geriatric Research (B.T.M., A.M.M.), Education and Clinical Center, VA Puget Sound Health Care System, Seattle, Washington 98108; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195.
Fred Hutch Cancer Center · USUniversity of Washington · US

Funding

PILOT STUDY--CLINICAL NUTRITION RESEARCHP30DK035816 · NIDDK · UNIVERSITY OF WASHINGTON · PI GREGORY J MORTON · 1986 to 2026
$30.4M
Diabetes, Obesity and Metabolism Training ProgramT32DK007247 · NIDDK · UNIVERSITY OF WASHINGTON · PI GREGORY J MORTON, KRISTINA Marie UTZSCHNEIDER · 1986 to 2026
$10.0M
Nutrition, Obesity and Atherosclerosis Training ProgramT32HL007028 · NHLBI · UNIVERSITY OF WASHINGTON · PI Karin E Bornfeldt · 1985 to 2026
$6.4M
Men's Reproductive Health Research at the Univ of WashingtonK12HD053984 · NICHD · UNIVERSITY OF WASHINGTON · PI BREMNER, WILLIAM J · 2006 to 2016
$2.9M
Dose-response relationships between circulating and intraprostatic androgens in mR01AG037603 · NIA · UNIVERSITY OF WASHINGTON · PI PAGE, STEPHANIE T · 2010 to 2014
$1.6M
NHLBI NIH HHS T32 HL007028NIA NIH HHS R01 AG037603NICHD NIH HHS K12 HD053984NIDDK NIH HHS P30 DK035816NIDDK NIH HHS T32 DK007247
6 · The paper itself

Abstract

contextConcern exists that T replacement therapy (TRT) might increase the risk of prostate disease. There are limited data regarding the impact of TRT on prostate androgen concentrations.

objectiveDetermine the dose-dependent effects of exogenous T administration on intraprostatic androgen concentrations.

designTwelve-week, double-blinded, randomized, placebo-controlled trial.

settingAcademic medical center.

participantsSixty-two healthy eugonadal men, aged 25-55 years.

interventionsSubjects were randomly assigned to receive injections of acyline, a GnRH antagonist (used to achieve medical castration), every 2 weeks plus transdermal T gel (1.25 g, 2.5 g, 5.0 g, 10 g, or 15 g daily), or placebo injections and transdermal gel for 12 weeks. MAIN OUTCOMES: Serum T and dihydrotestosterone (DHT) were measured at baseline and every 2 weeks during treatment. Intraprostatic T and DHT concentrations were assessed from tissue obtained through ultrasound-guided prostate needle biopsies at week 12. Androgens were quantified by liquid chromatography-tandem mass spectrometry.

results51 men completed the study and were included in the analysis. There were no significant adverse events. Exogenous T resulted in a dose-dependent increase in serum T and DHT concentrations (190-770 and 60-180 ng/dL, respectively). Although intraprostatic T differed among dose groups (P = .01), intraprostatic DHT was comparable regardless of T dose (P = .11) and was 10- to 20-fold greater than intraprostatic T.

conclusionsIn healthy, medically castrate men receiving exogenous T, the total intraprostatic androgen concentration (predominantly DHT) remained stable across serum T concentrations within the physiological range. These findings further our knowledge of the relationship between serum and intraprostatic androgens and suggest that physiological serum T achieved by TRT is unlikely to alter the prostate hormonal milieu.

Indexed as

OrchiectomyAdultDihydrotestosteroneGonadotropin-Releasing HormoneHealthHormone Replacement TherapyHumansMaleMiddle AgedOligopeptidesProstateTestosteroneTreatment OutcomeacylineDihydrotestosteroneGonadotropin-Releasing HormoneOligopeptidesTestosterone

Identifiers

PMID27172434
PMCPMC4929843
OpenAlexW2349392032

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.