Evidence map›Paper›PMID 42112614›Full record

Trial reportThe oncologist2026

A phase I/II trial of concurrent chemo-hormonal enzalutamide and cabazitaxel in patients with metastatic castration-resistant prostate cancer.

Julie N Graff, Claire E P Smith, Alexandra O Sokolova, David Z Qian, Tomasz M Beer, Emile Latour, Shawna Bailey, Dustin Kreitner, Petros Grivas, Michael T Schweizer and 5 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Julie N GraffDivision of Hematology/Medical Oncology, School of Medicine, OHSU Knight Cancer Institute, Portland, OR, USA.
Claire E P SmithDivision of Hematology and Oncology, Boston University School of Medicine, Boston Medical Center, Boston, MA, USA.
Alexandra O SokolovaDivision of Hematology/Medical Oncology, School of Medicine, OHSU Knight Cancer Institute, Portland, OR, USA.
David Z QianDivision of Hematology/Medical Oncology, School of Medicine, OHSU Knight Cancer Institute, Portland, OR, USA.
Tomasz M BeerDivision of Hematology/Medical Oncology, School of Medicine, OHSU Knight Cancer Institute, Portland, OR, USA.
Emile LatourBiostatistics Shared Resource, Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
Shawna BaileyDivision of Hematology/Medical Oncology, School of Medicine, OHSU Knight Cancer Institute, Portland, OR, USA.
Dustin KreitnerDivision of Hematology/Medical Oncology, School of Medicine, OHSU Knight Cancer Institute, Portland, OR, USA.
Petros GrivasDepartment of Medicine (Division Hematology/Oncology), University of Washington School of Medicine, Seattle, WA, USA.
Michael T SchweizerDepartment of Medicine (Division Hematology/Oncology), University of Washington School of Medicine, Seattle, WA, USA.ORCID 0000-0002-5510-0661
Celestia S HiganoDepartment of Medicine (Division Hematology/Oncology), University of Washington School of Medicine, Seattle, WA, USA.
Joshi J AlumkalGenitourinary Medical Oncology Section, University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Jacqueline VukyDivision of Hematology/Medical Oncology, School of Medicine, OHSU Knight Cancer Institute, Portland, OR, USA.
Evan Y YuDepartment of Medicine (Division Hematology/Oncology), University of Washington School of Medicine, Seattle, WA, USA.
Heather H ChengDepartment of Medicine (Division Hematology/Oncology), University of Washington School of Medicine, Seattle, WA, USA.ORCID 0000-0002-1365-0702

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Eric Collisson · 1985 to 2026
$296.4M
Understanding the origins of rapid recurrence of pancreatic cancer after resectionP30CA069533 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI Luiz Eduardo Bertassoni · 1997 to 2026
$60.5M
TRANSCRIPTOME AND PROTEOME STRATIFICATION OF PROSTATE ADENOCARCINOMA PHENOTYPESP50CA097186 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI PETER S NELSON · 2002 to 2026
$58.1M
Astellas Pharma Global Development, Pfizer, IncDepartment of Defense Prostate Cancer Research W81XWH-17-2-0043Department of Defense Prostate Cancer Research W81XWH-22-2-0021NCI NIH HHS CA097186NCI NIH HHS P30 CA015704NCI NIH HHS P30CA015704NCI NIH HHS P30 CA069533NCI NIH HHS P30CA069533NCI NIH HHS P50 CA097186Sanofi
6 · The paper itself

Abstract

BACKGROUND AND

objectiveDespite treatment advances, treatment resistance for metastatic castration-resistant prostate cancer (mCRPC) is nearly universal. We studied the efficacy, safety, and pharmacokinetic properties of the combination of enzalutamide and cabazitaxel in patients with mCRPC. For phase 1, we examined the safety of combination therapy and determined the recommended phase 2 dose. Phase 2 primary endpoint included the percentage of patients achieving a ≥ 90% PSA decline (PSA90) as a measure of response to therapy.

methodsA phase 1/2 single-arm, multi-institutional clinical trial enrolled adults with histologically confirmed progressive mCRPC without prior docetaxel or cabazitaxel chemotherapy for mCRPC. Co-administration of enzalutamide 160 mg orally once daily, cabazitaxel 25 mg/m2 IV once every 21 days, and prednisone 5 mg orally twice daily in mCRPC. Descriptive statistical analysis was used for all primary and secondary endpoints. Estimated proportions are with 95% confidence interval using the exact method. KEY

findingsThe study met its primary endpoint with 61.1% (95% CI, 43.5% to 76.9%) of patients achieving PSA90. Observed toxicities were similar to those seen with either agent alone.

conclusionsThe combination of enzalutamide and cabazitaxel exhibited robust activity with tolerable side effects. Chemo-hormonal therapies warrant further study in mCRPC. WHAT DOES THE STUDY ADD: This study of enzalutamide and cabazitaxel combination therapy in patients with advanced, pre-treated mCRPC showed promising efficacy, indicating strong rationale for further investigation. PATIENT SUMMARY: In this report we looked at outcomes for patients with metastatic prostate cancer treated at multiple institutions with enzalutamide and cabazitaxel at the same time after castration therapy alone had stopped working. We found the combination was safe and had anti-cancer effect, warranting further investigation.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsPhenylthiohydantoinProstatic Neoplasms, Castration-ResistantTaxoidsAgedAged, 80 and overBenzamidesHumansMaleMiddle AgedNeoplasm MetastasisNitrilesBenzamidescabazitaxelenzalutamideNitrilesPhenylthiohydantoinTaxoidscabazitaxelcastration-resistantenzalutamidemetastatic prostate cancerpharmacodynamics

Identifiers

PMID42112614
PMCPMC13228131

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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.