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Clinical perspectives from ongoing trials in oligometastatic or oligorecurrent prostate cancer: an analysis of clinical trials registries

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Abstract

Purpose

Thanks to the introduction of more sensitive/specific imaging and minimally invasive treatment techniques, the oligometastatic state in prostate cancer (PCa) has attracted the interest of the uro-oncological community. We aim to identify and analyze trials across five registries to gain insights into the directions this field is moving.

Methods

A systematic review of trials on oligometastatic PCa registered on ClinicalTrials.gov, ANZCTR, ISRCTN, Netherlands and UMIN Clinical Trials Registries was performed using the following keywords: ‘prostate cancer’ and ‘oligo’. Data were extracted from ongoing/completed trials, with an unreported primary endpoint in a peer-reviewed journal, as of May until August, 2018.

Results

We identified 41 trials on oligometastatic PCa. Twenty-four trials are conducted in North America and 14 in Europe. Up to 70% are phase I or II trials and < 10% (n = 4) are in phase III. Less than 50% (n = 17) are randomized controlled trials. Oligometastases are PET detected in 25 trials. Studies on synchronous oligometastatic (n = 12; 29%) or oligorecurrent (n = 14; 34%) PCa are equally represented, the remainder focus on mixed states (n = 15; 37%). The majority (n = 39; 95%) of trials investigate local treatment options (RP: 5; RT: 9; RP ± RT: 7; metastasis-directed therapy: 28) with (72%) or without (28%) systemic treatment. The remaining two are imaging studies. Progression-free (PFS; 17/41; 41%) or overall survival (OS; 3/41; 7%) is defined as primary endpoint in half of all trials, others are ‘safety/toxicity’ or ‘PSA response’.

Conclusions

With 41 ongoing trials, there is great interest in oligometastatic PCa. Most trials address local ablative treatments both for prostate and/or metastases, typically by radiotherapy, and several attempts to determine the benefit of adding systemic therapy. The field will hopefully have definitive answers after completion of four ongoing phase III trials.

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Acknowledgements

GAP6 consortium contributing authors: Boutros Paul C. (Department of Human Genetics, University of California, Los Angeles, CA, USA; Department of Urology, University of California, Los Angeles, CA, USA; Jonsson Comprehensive Cancer Centre, University of California, Los Angeles, CA, USA; Institute for Precision Health, University of California, Los Angeles, CA, USA), Buzza Mark (The Movember Foundation, Melbourne, Australia.), Corcoran Niall M. (Department of Urology, Royal Melbourne and Frankston Hospitals, Melbourne, Australia; Department of Surgery, University of Melbourne, Melbourne, Australia; Victorian Comprehensive Cancer Centre, Melbourne, Australia), Dal Pra Alan (Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL, USA; Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland), Emmenegger Urban (Division of Medical Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada; Biological Sciences, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada), Fraser Michael (Ontario Institute for Cancer Research (OICR), Toronto, Canada), Hovens Chris M. (Department of Surgery, University of Melbourne, Melbourne, Australia), Koontz Bridget F. (Department of Radiation Oncology, Duke Cancer Institute, Durham, North Carolina, USA), Lapointe Jacques (Division of Experimental Medicine, McGill University and the Research Institute of the McGill University Health Centre, Montreal, QC, Canada; Department of Surgery, Division of Urology, McGill University and the Research Institute of the McGill University Health Centre, Montréal, Québec, Canada), Vela Ian (Department of Urology, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Australian Prostate Cancer Research Center QLD, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia)

Author information

Authors and Affiliations

  1. Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent University, C. Heymanslaan 10, 9000, Ghent, Belgium

    Aurélie De Bruycker & Piet Ost

  2. Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine Hospital, Baltimore, USA

    Phuoc T. Tran

  3. The Movember Foundation, Melbourne, Australia

    Ariel H. Achtman

Authors
  1. Aurélie De Bruycker
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  2. Phuoc T. Tran
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  3. Ariel H. Achtman
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  4. Piet Ost
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Consortia

GAP6 consortium

  • Paul C. Boutros
  • , Mark Buzza
  • , Niall M. Corcoran
  • , Alan Dal Pra
  • , Urban Emmenegger
  • , Michael Fraser
  • , Chris M. Hovens
  • , Bridget F. Koontz
  • , Jacques Lapointe
  •  & Ian Vela

Contributions

AB: Data collection and management, data analysis, manuscript writing and editing. PO: Project development, manuscript writing and editing. PTT: Project development, manuscript review and editing. AHA: Manuscript review and editing. GAP6 consortium contributing authors: Manuscript review and editing. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Aurélie De Bruycker.

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Conflict of interest

A. De Bruycker: No conflicts of interest. P.T. Tran: Phuoc Tran has grant support from Astellas Pharm., RefleXion Medical, Inc and Bayer Healthcare; and has consulted for RefleXion Medical, Inc. Inventor on a patent regarding compounds and methods of use in ablative radiotherapy (patent filed 3/9/2012; PCT/US2012/028475, PCT/WO/2012/122471) licensed to Natsar Pharm. A.H. Achtman: No conflicts of interest. P. Ost: Consulting or Advisory Role: Ferring Pharmaceuticals (Inst), Bayer AG (Inst), Janssen (Inst). Research Funding: Merck (Inst), Varian (Inst). Travel, Accommodations, Expenses: Ipsen, Ferring Pharmaceuticals.

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The members of GAP6 consortium are mentioned in acknowledgements.

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De Bruycker, A., Tran, P.T., Achtman, A.H. et al. Clinical perspectives from ongoing trials in oligometastatic or oligorecurrent prostate cancer: an analysis of clinical trials registries. World J Urol 39, 317–326 (2021). https://doi.org/10.1007/s00345-019-03063-4

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  • DOI: https://doi.org/10.1007/s00345-019-03063-4

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