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

Alexandros Tsikkinis, Nikola Cihoric, Gianluca Giannarini, Stefan Hinz, Alberto Briganti, Peter Wust, Piet Ost, Guillaume Ploussard, Christophe Massard, Cristian I. Surcel, Prasanna Sooriakumaran, Hendrik Isbarn, Peter J L De Visschere, Jurgen J. Futterer, Roderick C N van der Bergh, Alan Dal Pra, Daniel M. Aebersold, Volker Budach, Pirus Ghadjar

Research output: Contribution to journalArticle

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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. Conclusion: There are many PCa phase 3 trials with pending results, most of which 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. 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. In this report we describe all phase 3 trials on prostate cancer registered in the ClinicalTrials.gov database with pending results. The majority of the trials identified address questions regarding systemic treatments for both nonmetastatic and metastatic disease. Radiation therapy and androgen deprivation therapy are interventions most frequently tested for local and systemic treatment, respectively.

Original languageEnglish
Pages (from-to)173-184
Number of pages12
JournalEuropean Urology Focus
Volume1
Issue number2
DOIs
Publication statusPublished - Sep 1 2015

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Prostatic Neoplasms
Databases
Therapeutics
Androgens
Radiotherapy
Clinical Trials
Radiopharmaceuticals
North America
Immunotherapy
Prostate
Drug Therapy

Keywords

  • ClinicalTrials.gov
  • Prospective
  • Prostate cancer
  • Trials

ASJC Scopus subject areas

  • Urology

Cite this

Clinical Perspectives from Randomized Phase 3 Trials on Prostate Cancer : An Analysis of the ClinicalTrials.gov Database. / Tsikkinis, Alexandros; Cihoric, Nikola; Giannarini, Gianluca; Hinz, Stefan; Briganti, Alberto; Wust, Peter; Ost, Piet; Ploussard, Guillaume; Massard, Christophe; Surcel, Cristian I.; Sooriakumaran, Prasanna; Isbarn, Hendrik; De Visschere, Peter J L; Futterer, Jurgen J.; van der Bergh, Roderick C N; Dal Pra, Alan; Aebersold, Daniel M.; Budach, Volker; Ghadjar, Pirus.

In: European Urology Focus, Vol. 1, No. 2, 01.09.2015, p. 173-184.

Research output: Contribution to journalArticle

Tsikkinis, A, Cihoric, N, Giannarini, G, Hinz, S, Briganti, A, Wust, P, Ost, P, Ploussard, G, Massard, C, Surcel, CI, Sooriakumaran, P, Isbarn, H, De Visschere, PJL, Futterer, JJ, van der Bergh, RCN, Dal Pra, A, Aebersold, DM, Budach, V & Ghadjar, P 2015, 'Clinical Perspectives from Randomized Phase 3 Trials on Prostate Cancer: An Analysis of the ClinicalTrials.gov Database', European Urology Focus, vol. 1, no. 2, pp. 173-184. https://doi.org/10.1016/j.euf.2015.05.003
Tsikkinis, Alexandros ; Cihoric, Nikola ; Giannarini, Gianluca ; Hinz, Stefan ; Briganti, Alberto ; Wust, Peter ; Ost, Piet ; Ploussard, Guillaume ; Massard, Christophe ; Surcel, Cristian I. ; Sooriakumaran, Prasanna ; Isbarn, Hendrik ; De Visschere, Peter J L ; Futterer, Jurgen J. ; van der Bergh, Roderick C N ; Dal Pra, Alan ; Aebersold, Daniel M. ; Budach, Volker ; Ghadjar, Pirus. / Clinical Perspectives from Randomized Phase 3 Trials on Prostate Cancer : An Analysis of the ClinicalTrials.gov Database. In: European Urology Focus. 2015 ; Vol. 1, No. 2. pp. 173-184.
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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. Conclusion: There are many PCa phase 3 trials with pending results, most of which 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. 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. In this report we describe all phase 3 trials on prostate cancer registered in the ClinicalTrials.gov database with pending results. The majority of the trials identified address questions regarding systemic treatments for both nonmetastatic and metastatic disease. Radiation therapy and androgen deprivation therapy are interventions most frequently tested for local and systemic treatment, respectively.",
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T1 - Clinical Perspectives from Randomized Phase 3 Trials on Prostate Cancer

T2 - An Analysis of the ClinicalTrials.gov Database

AU - Tsikkinis, Alexandros

AU - Cihoric, Nikola

AU - Giannarini, Gianluca

AU - Hinz, Stefan

AU - Briganti, Alberto

AU - Wust, Peter

AU - Ost, Piet

AU - Ploussard, Guillaume

AU - Massard, Christophe

AU - Surcel, Cristian I.

AU - Sooriakumaran, Prasanna

AU - Isbarn, Hendrik

AU - De Visschere, Peter J L

AU - Futterer, Jurgen J.

AU - van der Bergh, Roderick C N

AU - Dal Pra, Alan

AU - Aebersold, Daniel M.

AU - Budach, Volker

AU - Ghadjar, Pirus

PY - 2015/9/1

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N2 - 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. Conclusion: There are many PCa phase 3 trials with pending results, most of which 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. 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. In this report we describe all phase 3 trials on prostate cancer registered in the ClinicalTrials.gov database with pending results. The majority of the trials identified address questions regarding systemic treatments for both nonmetastatic and metastatic disease. Radiation therapy and androgen deprivation therapy are interventions most frequently tested for local and systemic treatment, respectively.

AB - 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. Conclusion: There are many PCa phase 3 trials with pending results, most of which 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. 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. In this report we describe all phase 3 trials on prostate cancer registered in the ClinicalTrials.gov database with pending results. The majority of the trials identified address questions regarding systemic treatments for both nonmetastatic and metastatic disease. Radiation therapy and androgen deprivation therapy are interventions most frequently tested for local and systemic treatment, respectively.

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