Evidence map›Paper›PMID 39450762›Full record

Trial reportThe oncologist2025

Functional assessment in patients with castration-resistant prostate cancer treated with darolutamide: results from the DaroAcT study.

Tomasz M Beer, Daniel J George, Neal D Shore, Kerri Winters-Stone, Jeffrey S Wefel, Frank Verholen, Shankar Srinivasan, Jorge Ortiz, Alicia K Morgans

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04157088 (A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04157088 phase2terminatednot on this map

A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide

TypeinterventionalSponsorBayerRan2019 to 2022Enrolled30ConditionsProstatic Cancer, Castration-ResistantArmsDarolutamide (Nubeqa, BAY1841788), Enzalutamide
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

9 authors.

Tomasz M BeerKnight Cancer Institute, Oregon Health and Science University, Portland, OR 98239, United States.ORCID 0000-0001-5600-9993
Daniel J GeorgeDuke Cancer Institute, Duke University Shool of Medicine, Durham, NC, United States.
Neal D ShoreCarolina Urologic Research Center, Myrtle Beach, SC, United States.
Kerri Winters-StoneKnight Cancer Institute, Oregon Health and Science University, Portland, OR 98239, United States.ORCID 0000-0003-1706-8020
Jeffrey S WefelDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Frank VerholenBayer Consumer Care, Basel, Switzerland.
Shankar SrinivasanBayer Healthcare Pharmaceuticals, Inc., Whippany, NJ, United States.
Jorge OrtizBayer Healthcare Pharmaceuticals, Inc., Whippany, NJ, United States.
Alicia K MorgansDana-Farber Cancer Institute, Boston, MA, United States.

Funding

Bayer HealthCare Pharmaceuticals
6 · The paper itself

Abstract

backgroundAndrogen receptor inhibitors (ARIs) are approved for the treatment of advanced prostate cancer; however, some patients may experience symptoms and side effects that hinder their physical functioning. The Timed Up and Go (TUG) and Short Physical Performance Battery (SPPB) tests are used to assess physical functioning in older adults and are recommended assessments for patients with prostate cancer, despite lacking validation in this setting.

methodsDaroAct (NCT04157088) was an open-label, multicenter, phase 2b study designed to evaluate the effects of the ARI darolutamide (lead-in phase) and darolutamide vs enzalutamide (randomized phase) on physical functioning in men with castration-resistant prostate cancer (CRPC). Only the lead-in phase, in which participants received darolutamide 600 mg twice daily, was completed. The TUG and SPPB tests were used to assess physical functioning.

resultsThe lead-in phase enrolled 30 participants. During 24 weeks of treatment, 8 (32.0%) of 25 evaluable participants exhibited clinically meaningful worsening in TUG from baseline (primary endpoint). At the week 24 visit, 5 (21.7%) of 23 participants had worsening in TUG time, and 8 (33.3%) of 24 participants had worsening in SPPB score. Because only 48% of participants had the same outcome on the TUG and SPPB tests, the study was terminated without initiating the randomized comparison.

conclusionMost participants showed no clinically meaningful worsening in physical functioning after 24 weeks of darolutamide treatment, but poor agreement between tests was observed. Tools to accurately and consistently measure the impact of ARIs on physical functioning in patients with CRPC are needed.

Indexed as

Androgen Receptor AntagonistsBenzamidesProstatic Neoplasms, Castration-ResistantPyrazolesAgedAged, 80 and overHumansMaleMiddle AgedNitrilesPhenylthiohydantoinAndrogen Receptor AntagonistsBenzamidesdarolutamideenzalutamideNitrilesPhenylthiohydantoinPyrazolesadverse effectsdarolutamidegait analysisphysical functional performanceprostate cancer

Identifiers

PMID39450762
PMCPMC12311285

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Registered trials

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.