Prostate Cancer

Project Title: Clinical Perspectives from Randomized Phase 3 Trials on Prostate Cancer: An Analysis of the ClinicalTrials.gov Database

Start Date: August 2014
End Date: May 2015

Authors

  1. Alexandros Tsikkinisa,
  2. Nikola Cihorica,
  3. Gianluca Giannarinib,
  4. Stefan Hinzc,
  5. Alberto Brigantid,
  6. Peter Wuste,
  7. Piet Ostf,
  8. Guillaume Ploussardg,
  9. Christophe Massardh,
  10. Christian I. Surceli,
  11. Prasanna Sooriakumaranj,
  12. Hendrik Isbarnk,
  13. Peter J.L. De Visscherei,
  14. Jurgen J. Futtererm,
  15. Roderick C.N. van der Berghn,
  16. Alan Dal Praa,
  17. Daniel M. Aebersolda,
  18. Volker Budache,
  19. Pirus Ghadjare

Authors information

  1. Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
  2. Department of Urology, University of Udine, Udine, Italy
  3. Department of Urology, Charité Universitätsmedizin Berlin, Berlin, Germany
  4. Unit of Urology/Division of Oncology; URI; IRCCS Ospedale San Raffaele, Milan, Italy
  5. Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany
  6. Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium
  7. Department of Urology, Saint-Louis Hospital, Paris, France
  8. Institut Gustave Roussy, University of Paris Sud, Villejuif, France
  9. Centre of Urological Surgery, Dialysis and Renal Transplantation, Fundeni Clinical Institute, Bucharest, Romania
  10. Surgical Intervention Trials Unit, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK
  11. Regio Clinicum Wedel, Department of Urology and Martini-Clinic, Prostate Cancer Center, Hamburg-Eppendorf, Germany
  12. Department of Radiology, Division of Genitourinary Radiology, Ghent University Hospital, Ghent, Belgium
  13. Department of Radiology, Radboud University, Nijmegen Medical Centre, Nijmegen, The Netherlands
  14. Department of Urology, University Medical Centre Utrecht, Utrecht, The Netherlands

Abstract

Background

It is not easy to overview pending phase 3 trials on prostate cancer (PCa), and awareness of these trials would benefit clinicians.

Objective

To identify all phase 3 trials on PCa registered in the ClinicalTrials.gov database with pending results.

Design and setting

On September 29, 2014, a database was established from the records for 175 538 clinical trials registered on ClinicalTrials.gov. A search of this database for the substring “prostat” identified 2951 prostate trials. Phase 3 trials accounted for 441 studies, of which 333 concerned only PCa. We selected only ongoing or completed trials with pending results, that is, for which the primary endpoint had not been published in a peer-reviewed medical journal.

Results and limitations

We identified 123 phase 3 trials with pending results. Trials were conducted predominantly in North America (n = 63; 51%) and Europe (n = 47; 38%). The majority were on nonmetastatic disease (n = 82; 67%), with 37 (30%) on metastatic disease and four trials (3%) including both. In terms of intervention, systemic treatment was most commonly tested (n = 71; 58%), followed by local treatment 34 (28%), and both systemic and local treatment (n = 11; 9%), with seven (6%) trials not classifiable. The 71 trials on systemic treatment included androgen deprivation therapy (n = 34; 48%), chemotherapy (n = 15; 21%), immunotherapy (n = 9; 13%), other systemic drugs (n = 9; 13%), radiopharmaceuticals (n = 2; 3%), and combinations (n = 2; 3%). Local treatments tested included radiation therapy (n = 27; 79%), surgery (n = 5; 15%), and both (n = 2; 2%). A limitation is that not every clinical trial is registered on ClinicalTrials.gov.

Patient summary

This report describes all phase 3 trials on prostate cancer registered in the ClinicalTrials.gov database with pending results. Most of these trials address questions regarding systemic treatments for both nonmetastatic and metastatic disease. Radiation therapy and androgen deprivation therapy are the interventions most commonly tested for local and systemic treatment, respectively.

Keywords

Prostate cancer; Trials; ClinicalTrials.gov; Prospective

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