Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015
Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer.
Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 198 papers, 6 of them syntheses that pooled it.
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198citing papers in PubMed, 6 pooled it
–field-weighted citation impact
What it found
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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.
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Who cites it
198 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- [Comorbidities affecting abiraterone treatment in patients with metastatic castration-resistant prostate cancer: a meta- analysis].Magyar onkologia · 2026Pooled it
- Comparative efficacy of olaparib in combination with or without novel antiandrogens for treating metastatic castration-resistant prostate cancer.Frontiers in endocrinology · 2023Pooled it
- Quantitative and Qualitative Analysis of Blood-based Liquid Biopsies to Inform Clinical Decision-making in Prostate Cancer.European urology · 2021Pooled it
- SEOM clinical guidelines for the treatment of advanced prostate cancer (2020).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021Guideline
- Can RECIST response predict success in phase 3 trials in men with metastatic castration-resistant prostate cancer?Prostate cancer and prostatic diseases · 2018Pooled it
- Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Guideline
- Chromosomal instability in circulating tumor cells and cabazitaxel resistance in metastatic castration-resistant prostate cancer.JCI insight · 2025Trial
- Circulating Tumor Cell Count and Overall Survival in Patients With Metastatic Hormone-Sensitive Prostate Cancer.JAMA network open · 2024Trial
- A correlative biomarker study and integrative prognostic model in chemotherapy-naïve metastatic castration-resistant prostate cancer treated with enzalutamide.The Prostate · 2023Trial
- Baseline Circulating Tumor Cell Count as a Prognostic Marker of PSA Response and Disease Progression in Metastatic Castrate-Sensitive Prostate Cancer (SWOG S1216).Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Trial
- Endothelium-Derived Extracellular Vesicles Associate with Poor Prognosis in Metastatic Colorectal Cancer.Cells · 2020Trial
- Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): a multicentre, open-label, randomised, phase 2 trial.The Lancet. Oncology · 2020Trial
- AR splice variants in circulating tumor cells of patients with castration-resistant prostate cancer: relation with outcome to cabazitaxel.Molecular oncology · 2019Trial
- Prospective Multicenter Validation of Androgen Receptor Splice Variant 7 and Hormone Therapy Resistance in High-Risk Castration-Resistant Prostate Cancer: The PROPHECY Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Pharmacodynamic study of radium-223 in men with bone metastatic castration resistant prostate cancer.PloS one · 2019Trial
- An RNA-Based Digital Circulating Tumor Cell Signature Is Predictive of Drug Response and Early Dissemination in Prostate Cancer.Cancer discovery · 2018Trial
- Circulating Cell-Free DNA to Guide Prostate Cancer Treatment with PARP Inhibition.Cancer discovery · 2017Trial
- Androgen receptor gene status in plasma DNA associates with worse outcome on enzalutamide or abiraterone for castration-resistant prostate cancer: a multi-institution correlative biomarker study.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- An exploratory analysis of alkaline phosphatase, lactate dehydrogenase, and prostate-specific antigen dynamics in the phase 3 ALSYMPCA trial with radium-223.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel.Annals of oncology : official journal of the European Society for Medical Oncology · 2016Trial
138 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
16 authors.
Howard I ScherHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium. scherh@mskcc.org.
Glenn HellerHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Arturo MolinaHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Gerhardt AttardHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Daniel C DanilaHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Xiaoyu JiaHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Weimin PengHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Shahneen K SandhuHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
David OlmosHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Ruth RiisnaesHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Robert McCormackHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Tomasz BurzykowskiHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Thian KheohHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Martin FleisherHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Marc BuyseHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Johann S de BonoHoward I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of Cancer Research; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, and Johann S. de Bono, Royal Marsden Hospital, Sutton, United Kingdom; Robert McCormack, Janssen Research & Development, Raritan, NJ; and Tomasz Burzykowski and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.
Funding
X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4MSPORE In Prostate CancerP50CA092629 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Yu Chen, MICHAEL J MORRIS · 2001 to 2026
$63.0MCancer Research UK 13239Medical Research Council G0601308NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA092629NCI NIH HHS P50 CA92629Prostate Cancer UK PG12-49
Abstract
purposeTrials in castration-resistant prostate cancer (CRPC) need new clinical end points that are valid surrogates for survival. We evaluated circulating tumor cell (CTC) enumeration as a surrogate outcome measure. PATIENTS AND
methodsExamining CTCs alone and in combination with other biomarkers as a surrogate for overall survival was a secondary objective of COU-AA-301, a multinational, randomized, double-blind phase III trial of abiraterone acetate plus prednisone versus prednisone alone in patients with metastatic CRPC previously treated with docetaxel. The biomarkers were measured at baseline and 4, 8, and 12 weeks, with 12 weeks being the primary measure of interest. The Prentice criteria were applied to test candidate biomarkers as surrogates for overall survival at the individual-patient level.
resultsA biomarker panel using CTC count and lactate dehydrogenase (LDH) level was shown to satisfy the four Prentice criteria for individual-level surrogacy. Twelve-week surrogate biomarker data were available for 711 patients. The abiraterone acetate plus prednisone and prednisone-alone groups demonstrated a significant survival difference (P = .034); surrogate distribution at 12 weeks differed by treatment (P < .001); the discriminatory power of the surrogate to predict mortality was high (weighted c-index, 0.81); and adding the surrogate to the model eliminated the treatment effect on survival. Overall, 2-year survival of patients with CTCs < 5 (low risk) versus patients with CTCs ≥ 5 cells/7.5 mL of blood and LDH > 250 U/L (high risk) at 12 weeks was 46% and 2%, respectively.
conclusionA biomarker panel containing CTC number and LDH level was shown to be a surrogate for survival at the individual-patient level in this trial of abiraterone acetate plus prednisone versus prednisone alone for patients with metastatic CRPC. Additional trials are ongoing to validate the findings.
Indexed as
Abiraterone AcetateAdultAgedAged, 80 and overAndrostenesBiomarkers, TumorEndpoint DeterminationHumansL-Lactate DehydrogenaseMaleMiddle AgedNeoplasm MetastasisNeoplastic Cells, CirculatingProstatic Neoplasms, Castration-ResistantAbiraterone AcetateAndrostenesBiomarkers, TumorL-Lactate Dehydrogenase
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