Evidence map›Paper›PMID 40244528›Full record

SynthesisJournal of endocrinological investigation2025

Prevention of bicalutamide-induced breast events in patients with prostate cancer: a meta-analysis of randomized controlled trials.

Luca Spagnolo, Daniele Tienforti, Carolina Moretto, Camilla Tonni, Vittoria Donatelli, Alessandro Ferranti, Gennaro Puocci, Claudio Capuano, Arcangelo Barbonetti

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Journal of endocrinological investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
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.

Luca SpagnoloAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Daniele TienfortiAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy. danieletienforti@gmail.com.ORCID http://orcid.org/0000-0002-9359-7955
Carolina MorettoAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Camilla TonniAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Vittoria DonatelliDepartment of Veterinary Medicine, University of Teramo, Teramo, Italy.
Alessandro FerrantiAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Gennaro PuocciAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Claudio CapuanoAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Arcangelo BarbonettiAndrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to quantitatively assess the effectiveness of tamoxifen, anastrozole, and radiotherapy in preventing bicalutamide-induced breast events-specifically gynecomastia and breast pain-in patients with prostate cancer.

methodsA systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted according to PRISMA-P guidelines. A comprehensive search was performed in PubMed, Scopus, and Web of Science for English-language studies without temporal restrictions. Studies were included if they involved prostate cancer patients treated with bicalutamide receiving preventive interventions (tamoxifen, anastrozole, or radiotherapy) compared to bicalutamide alone (or bicalutamide plus placebo/sham). Data extraction focused on the incidence of gynecomastia and breast pain, and study quality was assessed using the Jadad scale. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using fixed- or random-effects models, and heterogeneity was evaluated with the I² statistic. Publication bias was explored via funnel plots and the trim-and-fill method.

resultsNine RCTs met the inclusion criteria. Tamoxifen significantly reduced the risk of breast events by 82% (RR: 0.18, 95% CI: 0.08-0.38 for gynecomastia and RR: 0.18, 95% CI: 0.07-0.43 for breast pain). Radiotherapy reduced gynecomastia risk by 52% (RR: 0.48, 95% CI: 0.38-0.59) and breast pain by 34% (RR: 0.66, 95% CI: 0.48-0.90). Anastrozole did not show significant benefit.

conclusionTamoxifen appears to be the most effective strategy for preventing bicalutamide-induced breast events, with radiotherapy serving as a viable alternative, and anastrozole offering no benefit. Further large-scale, high-quality studies are needed to confirm these findings and refine preventive treatment recommendations.

Indexed as

AnilidesGynecomastiaMastodyniaNitrilesProstatic NeoplasmsTosyl CompoundsAndrogen AntagonistsHumansMaleRandomized Controlled Trials as TopicTamoxifenAndrogen AntagonistsAnilidesbicalutamideNitrilesTamoxifenTosyl CompoundsAromataseBicalutamideGynecomastiaRadiotherapyTamoxifenTestosterone

Identifiers

PMID40244528
PMCPMC12313775

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.