Evidence map›Paper›PMID 39487924›Full record

Trial reportWorld journal of urology2024

Tumor regression after neoadjuvant hormonal therapy in high risk prostate cancer: pathological outcomes from a randomized phase II trial.

Leonardo Cardili, Diogo Assed Bastos, Eder Nisi Ilario, Marina Alessandra Pereira, Giuliano Bettoni Guglielmetti, Maurício Cordeiro, José Pontes, Rafael Ferreira Coelho, William Carlos Nahas, Katia Ramos Moreira Leite

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Review
  2. 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

10 authors.

Leonardo Cardili *Department of Pathology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil. leonardo.cardili@hc.fm.usp.br.ORCID http://orcid.org/0000-0001-9673-4030
Diogo Assed Bastos *Department of Clinical Oncology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
Eder Nisi IlarioDepartment of Urology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
Marina Alessandra PereiraDepartment of Pathology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
Giuliano Bettoni GuglielmettiDepartment of Urology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
Maurício CordeiroDepartment of Urology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
José PontesDepartment of Urology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
Rafael Ferreira CoelhoDepartment of Urology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
William Carlos NahasDepartment of Urology, Instituto do Câncer do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
Katia Ramos Moreira LeiteDepartment of Urology, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.

Funding

Cilag No
6 · The paper itself

Abstract

purposeHigh-risk localized prostate cancer (HRLPC) commonly progresses to metastatic disease after local treatment. Neoadjuvant androgen deprivation therapy (nADT) before radical prostatectomy (RP) has recently been suggested to improve early oncological outcomes in HRLPC. We aimed to perform an exploratory analysis of the pathological outcomes from a prospective trial testing nADT before RP.

methodsProspective, single-centered, phase II, randomized trial performed between October 2018 and July 2021. Random assignment (1:1) for nADT modalities: goserelin (10.8 mg) plus abiraterone acetate (1000 mg/d) plus prednisone (5 mg/d), with or without apalutamide (240 mg/d) for 12 weeks, followed by RP (within 30 days) and extended lymph node dissection. Baseline clinical and pathological variables were assessed in needle biopsies before nADT. Tumor regression was histologically evaluated in surgical specimens using the residual cancer burden index (RCB).

resultsSixty-two patients reached the surgical phase. Good response (RCB ≤ 0.25 cm³) was achieved in 14 patients (22.5%). Overall stage migration rate between baseline status (MRI before nADT) and final status (after surgery) was 27.4%. Late stage detection (high tumor burden, perineural invasion) and altered PTEN/ERG immunostatus showed significant association with poor response in univariate analysis. Higher baseline tumor burden was the only independent factor related to poor response in multivariate analysis.

conclusionsThere are subgroups of patients, such as those with low baseline cancer burden and PTEN/ERG wild-type status, more likely to achieve good response with nADT. In the case of long term oncological benefit to be proven, nADT might be an additional therapeutic resource for these patients.

Indexed as

GoserelinNeoadjuvant TherapyProstatic NeoplasmsAbiraterone AcetateAgedAndrogen AntagonistsAntineoplastic Agents, HormonalHumansMaleMiddle AgedPrednisoneProspective StudiesProstatectomyThiohydantoinsTreatment OutcomeAbiraterone AcetateAndrogen AntagonistsAntineoplastic Agents, HormonalapalutamideGoserelinPrednisoneThiohydantoinsAndrogen deprivation therapyImmunohistochemistryNeoadjuvant treatmentProstate cancerPTEN PhosphohydrolaseTranscriptional regulator ERG

Identifiers

What OpenQuestion holds

Textmetadata
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.