Evidence map›Paper›PMID 37335291›Full record

Trial reportOncotarget2023

Utilizing metformin to prevent metabolic syndrome due to androgen deprivation therapy (ADT): a randomized phase II study of metformin in non-diabetic men initiating ADT for advanced prostate cancer.

Devalingam Mahalingam, Salih Hanni, Anthony V Serritella, Christos Fountzilas, Joel Michalek, Brian Hernandez, John Sarantopoulos, Paromitta Datta, Ofelia Romero, Sureshkumar Mulampurath Achutan Pillai and 3 more

Erratum issuedOpen access · diamondFull text readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oncotarget, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 2 countries.

Devalingam MahalingamDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
Salih HanniDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
Anthony V SerritellaRobert H Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL 60611, USA.
Christos FountzilasDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
Joel MichalekDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
Brian HernandezDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
John SarantopoulosInstitute for Drug Development, Mays Cancer Center at University of Texas Health, San Antonio, TX 78229, USA.
Paromitta DattaAudie Murphy VA Hospital, San Antonio, TX 78229, USA.
Ofelia RomeroDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
Sureshkumar Mulampurath Achutan PillaiDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
John KuhnDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
Michael PollakDivision of Experimental Medicine, Lady Davis Institute of Medical Research, Jewish General Hospital, McGill University, Montreal, Canada.
Ian M ThompsonDivision of Hematology and Oncology, University of Texas Health Science Center, San Antonio, TX 77030, USA.
The University of Texas Health Science Center at San Antonio · USAudie L. Murphy Memorial VA Hospital · USChristus Health · USJewish General Hospital · CAMays Cancer Center at UT Health San AntonioNorthwestern University · USRoswell Park Comprehensive Cancer Center · US

Funding

TISSUE CULTURE---COREP30CA054174 · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · 1991 to 2025
$17.6M
NCI NIH HHS P30 CA054174
6 · The paper itself

Abstract

backgroundAndrogen deprivation therapy (ADT) can lead to metabolic syndrome (MS) and is implicated in ADT-resistance. Metformin showed antineoplastic activity through mTOR inhibition secondary AMPK-activation. MATERIALS AND

methodsTo investigate whether metformin mitigated ADT-related MS, we conducted a randomized double-blind phase II trial of metformin 500 mg TID or placebo in non-diabetic patients with biochemically-relapsed or advanced PC due for ADT. Fasting serum glucose, insulin, PSA, metformin, weight and waist circumference (WC) were measured at baseline, week 12 and 28. The primary endpoint was a group of MS metrics. Secondary endpoints include PSA response, safety, serum metformin concentrations and analysis of downstream an mTOR target, phospho-S6-kinase.

results36 men were randomized to either metformin or placebo. Mean age was 68.4. Mean weight, WC and insulin levels increased in both arms. At week 12 and 28, no statistical differences in weight, WC or insulin were observed in either arm. No significant difference in percentage of patients with PSA <0.2 at week 28 between metformin (45.5%) vs. placebo (46.7%). Analysis in the metformin-arm showed variable down-regulation of phospho-S6 kinase.

conclusionsIn our small study, metformin added to ADT did not show a reduced risk of ADT-related MS or differences in PSA response.

Indexed as

InsulinsMetabolic SyndromeMetforminProstatic NeoplasmsAgedAndrogen AntagonistsAndrogensHumansMaleProstate-Specific AntigenAndrogen AntagonistsAndrogensInsulinsMetforminProstate-Specific Antigenandrogen deprivation therapyclinical trialmetastaticmetforminprostate cancer

Identifiers

PMID37335291
PMCPMC10278660
OpenAlexW4381197866

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.