Evidence map›Paper›PMID 40319177›Full record

Trial reportProstate cancer and prostatic diseases2026

Addition of zoledronic acid to enzalutamide and androgen deprivation therapy in metastatic hormone-sensitive prostate cancer: the randomized phase II BONENZA trial.

Alberto Dalla Volta, Francesca Valcamonico, Andrea Zivi, Giuseppe Procopio, Pierangela Sepe, Gianluca Del Conte, Nunzia Di Meo, Silvia Foti, Stefania Zamboni, Caterina Messina and 10 more

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

Trial report in Prostate cancer and prostatic diseases, 2026. 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

20 authors.

Alberto Dalla VoltaUnit of Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy. alberto.dallavolta@gmail.com.ORCID http://orcid.org/0000-0001-8009-7663
Francesca ValcamonicoUnit of Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.
Andrea ZiviDivision of Oncology, Verona University and Hospital Trust (AOUI), Verona, Italy.
Giuseppe ProcopioMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Pierangela SepeDivision of Oncology, ASST Santi Paolo e Carlo Borromeo, Milan, Italy.
Gianluca Del ConteDepartment of Oncology, Fondazione IRCCS San Raffaele Hospital, Milan, Italy.ORCID http://orcid.org/0009-0000-0481-953X
Nunzia Di MeoUnit of Radiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.
Silvia FotiDepartment of Oncology, Fondazione IRCCS San Raffaele Hospital, Milan, Italy.
Stefania ZamboniUnit of Urology, Department of Medical and Surgical Specialties, Radiological Science and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.
Caterina MessinaUnit of Medical Oncology, ASST Papa Giovanni XXIII, Bergamo, Italy.
Eleonora LucchiniUnit of Medical Oncology, ASST Garda, Desenzano, Italy.
Anna RizziUnit of Medical Oncology, ASST Garda, Manerbio, Italy.
Marco RavanelliUnit of Radiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.
Stefano CalzaUnit of Biostatistics and Bioinformatics, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Francesca ZacchiDivision of Oncology, Verona University and Hospital Trust (AOUI), Verona, Italy.ORCID http://orcid.org/0000-0002-7448-7822
Giovannino CicconeUnit of Clinical Epidemiology, AOU Città della Salute e della Scienza di Torino and CPO Piemonte, Turin, Italy.
Nazareno SuardiUnit of Urology, Department of Medical and Surgical Specialties, Radiological Science and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.ORCID http://orcid.org/0000-0002-4331-3010
Roberto MaroldiUnit of Radiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.ORCID http://orcid.org/0000-0001-5664-353X
Davide FarinaUnit of Radiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.
Alfredo BerrutiUnit of Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.

Funding

Astellas | Astellas Pharma Global Development IT-72-RG-33/ISR004983Astellas Pharma Europe IT-72-RG-33/ISR004983
6 · The paper itself

Abstract

backgroundZoledronic acid (ZA) in combination with androgen deprivation therapy (ADT) has never proved additional activity in patients with advanced prostate cancer. However, conventional imaging is poorly reliable in monitoring disease response of metastatic bone lesions.

methodsBonEnza is a randomized phase II multicenter clinical trial designed to compare activity of ADT plus Enzalutamide (E) plus/minus ZA in term of bone response rate by Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (WB-DW-MRI). From February 2018 to June 2021, 126 patients with metastatic hormone-sensitive prostate cancer (mHSPC) and bone metastasis at bone scan were enrolled. Patients were randomized in a 1:1 to receive E 160 mg OD orally alone (E arm) or in combination with ZA 4 mg intravenously every 4 weeks (EZ arm). Primary endpoint of the study was overall response rate (ORR) in bone metastases, secondary endpoints were ORR with conventional imaging, progression free survival (PFS) and overall survival (OS). A logistic model was used to evaluate the association between treatment arm and ORR.

resultsAfter a median follow-up of 31.9 months, according to an intent to treat analysis, the ORR was superimposable in both arms: 69.8% (95% Confidence Interval [CI]: 57.5-79.9%), Odds Ratio: 1.00 (95%CI 0.47-2.15; p > 0.9). No advantage in favor of EZ arm over E arm emerged either in terms of PFS (Hazard Ratio [HR] 0.77, 95%CI 0.44-1.37; p = 0.4) or OS (HR 1.09; 95%CI 0.54-2.2; p = 0.8). A main limitation of this study was the inability of WB-DW-MRI to evaluate disease response in 17 patients.

conclusionsZA did not improve bone response rate to E plus ADT in mHSPC patients. WB-DW-MRI is a reliable technique to evaluate the response of prostate cancer bone metastases to systemic therapy.

Indexed as

Androgen AntagonistsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBone NeoplasmsPhenylthiohydantoinProstatic NeoplasmsZoledronic AcidAgedAged, 80 and overHumansMaleMiddle AgedNitrilesAndrogen AntagonistsBenzamidesenzalutamideNitrilesPhenylthiohydantoinZoledronic Acid

Identifiers

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Registered trials

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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.