Evidence map›Paper›PMID 34108181›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

A Phase Ib Study of Atezolizumab with Radium-223 Dichloride in Men with Metastatic Castration-Resistant Prostate Cancer.

Lawrence Fong, Michael J Morris, Oliver Sartor, Celestia S Higano, Lance Pagliaro, Ajjai Alva, Leonard J Appleman, Winston Tan, Ulka Vaishampayan, Raphaelle Porcu and 6 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
–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

35 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Targeted Radionuclide Therapy: Current Landscape and Combination Approaches to Improve Oncology Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  5. Radium-223 decreases PD-L1 expression in bone metastases: A study with [European journal of nuclear medicine and molecular imaging · 2026
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  18. Immunotherapy in metastatic prostate cancer.Therapeutic advances in medical oncology · 2025
    Review
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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

16 authors.

Lawrence Fong *Department of Urology, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California. lawrence.fong@ucsf.edu morrism@mskcc.org.ORCID 0000-0002-6428-428X
Michael J Morris *Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York, New York. lawrence.fong@ucsf.edu morrism@mskcc.org.ORCID 0000-0002-9454-0096
Oliver SartorDepartment of Urology, Tulane Cancer Center, New Orleans, Louisiana.ORCID 0000-0002-8777-7343
Celestia S HiganoDepartments of Medicine and Urology, University of Washington, Seattle, Washington.
Lance PagliaroDepartment of Oncology, Mayo Clinic, Rochester, Minnesota.
Ajjai AlvaDepartment of Internal Medicine, University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.
Leonard J ApplemanDepartment of Medicine, UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania.ORCID 0000-0003-4951-7388
Winston TanDepartment of Internal Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0003-4706-0310
Ulka VaishampayanEisenberg Center for Translational Therapeutics, Karmanos Cancer Institute, Detroit, Michigan.
Raphaelle PorcuProduct Development Oncology, F. Hoffmann-La Roche, Ltd., Basel, Switzerland.
Darren TayamaProduct Development Oncology, Genentech, Inc., South San Francisco, California.
Edward E KadelProduct Development Oncology, Genentech, Inc., South San Francisco, California.ORCID 0000-0003-3030-6628
Kobe C YuenProduct Development Oncology, Genentech, Inc., South San Francisco, California.
Asim DatyeProduct Development Oncology, F. Hoffmann-La Roche, Ltd., Basel, Switzerland.
Andrew J Armstrong *Department of Medical Oncology, Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, North Carolina.ORCID 0000-0001-7012-1754
Daniel P Petrylak *Department of Medical Oncology, Yale Cancer Center, New Haven, Connecticut.

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

purposeMen with metastatic castration-resistant prostate cancer (mCRPC) have limited treatment options after progressing on hormonal therapy and chemotherapy. Here, we evaluate the safety and efficacy of atezolizumab (anti-PD-L1) + radium-223 dichloride (radium-223) in men with mCRPC. PATIENTS AND

methodsThis phase Ib study evaluated atezolizumab + radium-223 in men with mCRPC and bone and lymph node and/or visceral metastases that progressed after androgen pathway inhibitor treatment. Following safety assessment of concurrent dosing, 45 men were randomized 1:1:1 to concurrent or one of two staggered dosing schedules with either agent introduced one cycle before the other. This was followed by a safety-efficacy expansion cohort (randomized 1:1:1). The primary endpoints were safety and objective response rate (ORR) by RECIST 1.1. Secondary endpoints included radiographic progression-free survival (rPFS), PSA responses, and overall survival (OS).

resultsAs of October 4, 2019, 44 of 45 men were evaluable. All 44 had ≥1 all-cause adverse event (AE); 23 (52.3%) had a grade 3/4 AE. Fifteen (34.1%) grade 3/4 and 3 (6.8%) grade 5 AEs were related to atezolizumab; none were related to radium-223. Confirmed ORR was 6.8% [95% confidence interval (CI), 1.4-18.7], median rPFS was 3.0 months (95% CI, 2.8-4.6), median PSA progression was 3.0 months (95% CI, 2.8-3.3), and median OS was 16.3 months (95% CI, 10.9-22.3).

conclusionsThis phase Ib study demonstrated that atezolizumab + radium-223, regardless of administration schedule, had greater toxicity than either drug alone, with no clear evidence of additional clinical benefit for patients with mCRPC and bone and lymph node and/or visceral metastases.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedCombined Modality TherapyDouble-Blind MethodHumansImmune Checkpoint InhibitorsMaleMiddle AgedNeoplasm MetastasisProstatic Neoplasms, Castration-ResistantRadiumAntibodies, Monoclonal, HumanizedatezolizumabImmune Checkpoint InhibitorsRadiumRadium-223

Identifiers

PMID34108181
PMCPMC8974420

What OpenQuestion holds

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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.