Evidence map›Paper›PMID 31082669›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2019

Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial.

Michael J Morris, Yohann Loriot, Christopher J Sweeney, Karim Fizazi, Charles J Ryan, Daniel H Shevrin, Emmanuel S Antonarakis, Neeta Pandit-Taskar, Désirée Deandreis, Heather A Jacene and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01106352 (A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
5.8field-weighted citation impact, top 3% of its field
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.

NCT01106352 phase1 / phase2completednot on this map

A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer

TypeinterventionalSponsorBayerRan2010 to 2015Enrolled70ConditionsBone Metastases, Castration-Resistant Prostate CancerArmsRadium-223 dichloride (Xofigo, BAY88-8223), Docetaxel
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 55 citations in OpenAlex.

  1. Trial
  2. Effect of taxaneZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2026
    Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. AlphaBet: Combination of Radium-223 and [Frontiers in medicine · 2022
    Article
  10. Article
  11. Why bother with alpha particles?European journal of nuclear medicine and molecular imaging · 2021
    Article
  12. Dosimetry in Clinical Radiopharmaceutical Therapy of Cancer: Practicality Versus Perfection in Current Practice.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2021
    Review
  13. Article
  14. Article
  15. Review
  16. The Radiobiology of Radiopharmaceuticals.Seminars in radiation oncology · 2021
    Review
  17. The Role of Theranostics in Prostate Cancer.Seminars in radiation oncology · 2021
    Review
  18. Article
  19. Observational
  20. 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

15 authors at 12 institutions in 2 countries.

Michael J MorrisDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA. Electronic address: morrism@mskcc.org.
Yohann LoriotDepartment of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Christopher J SweeneyMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Karim FizaziDepartment of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Charles J RyanDepartment of Medicine and Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
Daniel H ShevrinNorthShore Medical Group, NorthShore University Health System, Evanston Hospital Kellogg Cancer Center, Evanston, IL, USA.
Emmanuel S AntonarakisThe Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Neeta Pandit-TaskarDepartment of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Désirée DeandreisNuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.
Heather A JaceneDepartment of Imaging, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Hubert VesselleDivision of Nuclear Medicine, Department of Radiology, University of Washington, Seattle, WA, USA.
Oana PetrenciucDepartment of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
Cindy LuDepartment of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
Jorge A CarrasquilloDepartment of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Celestia S HiganoDepartment of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Memorial Sloan Kettering Cancer Center · USBayer (United States) · USBrigham and Women's Hospital · USDana-Farber Cancer Institute · USFred Hutch Cancer Center · USInserm · FRInstitut Gustave Roussy · FRNorthShore University HealthSystem · USSidney Kimmel Comprehensive Cancer Center · USUniversité Paris-Sud · FRUniversity of California, San Francisco · USUniversity of Washington · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeRadium 223 dichloride (radium-223) is an alpha particle-emitting bone-directed therapy that prolongs overall survival in men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC). Docetaxel is an antimicrotubule cytotoxic agent that improves survival in mCRPC. We investigated whether combining these potentially cross-sensitising agents to dually target tumour and bone would be safe and effective. PATIENTS AND

methodsPhase 1 was a dose escalation study to define a recommended phase 2 dose (RP2D) of docetaxel and radium-223. In phase 2a, patients were randomised 2:1 to the recommended combination regimen or docetaxel at a dose of 75 mg/m

resultsTwenty patients were enrolled in phase 1; 53 patients were randomised in phase 2a: 36 to combination treatment and 17 to docetaxel alone. The RP2D for the combination was radium-223 55 kBq/kg every six weeks × 5 doses, plus docetaxel 60 mg/m

conclusionsRadium-223 in combination with docetaxel at the RP2D was well tolerated. Exploratory efficacy data suggested enhanced antitumour activity for the combination relative to docetaxel alone. Comparative studies with end-points of clinical benefit are warranted. ClinicalTrials.gov number: NCT01106352.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsDocetaxelHumansMaleMiddle AgedProstatic Neoplasms, Castration-ResistantRadiumAntineoplastic AgentsDocetaxelRadiumRadium-223Castration-resistant prostate cancerCombination treatmentDocetaxelRadium 223 dichloride

Identifiers

PMID31082669
PMCPMC7474951
OpenAlexW2944042143

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.