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Poster display session

3686 - A Phase II Clinical Trial of Radium-223 Activity in Patients (pts) With Metastatic Castration-resistant Prostate Cancer (mCRPC) With Asymptomatic Progression While on Abiraterone Acetate or Enzalutamide Besides AR-V7 Mutational Status (EXCAAPE)

Date

10 Sep 2017

Session

Poster display session

Presenters

Joan Carles Galceran

Citation

Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370

Authors

J. Carles Galceran1, T. Bonfill Abella2, P. Borrega3, R. Collado3, J. Garde1, M.A. Gonzalez Del Alba Baamonde4, E. Grande Pulido5, B. Mellado6, M.J. Mendez Vidal7, J.M. Piulats Rodriguez8, R. Morales Barrera9, E. Gallardo Diaz2, P. Paredes6, C. Suarez Rodriguez9, O. Reig6, S. Vazquez Estevez10

Author affiliations

  • 1 Scientific, Medica Scientia Innovation Research-MEDSIR, 08007 - Barcelona/ES
  • 2 Oncology, Parc Taulí University Hospital. Parc Taulí Institute of Research and Innovation I3PT. Barcelona Autonomous University, 8208 - Sabadell/ES
  • 3 Oncology, San Pedro de Alcántara Hospital, Cáceres, Spain;, 10003 - Cáceres/ES
  • 4 Oncology, Son Espases University Hospital, 7010 - Palma de Mallorca/ES
  • 5 Oncology, Ramon y Cajal University Hospital, Madrid, Spain;, 28031 - Madrid/ES
  • 6 Medical Oncology, Clinic and Provincial University Hospital, 08036 - barcelona/ES
  • 7 Oncology, Reina Sofía University Hospital, 14004 - Cordoba/ES
  • 8 Oncology, Catalan Institute of Oncology, 8907 - Barcelona/ES
  • 9 Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 10 Medical Oncology, Lucus Augusti University Hospital, 27003 - Lugo/ES
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Resources

Abstract 3686

Background

Radium-223 is indicated for pts with mCRPC with symptomatic bone metastases. Biomarkers for radium-223 treatment and its correlation with AR-V7 splice variant, are both under research. The aim of this study is to assess the activity and safety of radium-223 stratified by AR-V7 status in asymptomatic pts who have progressed while on abiraterone acetate or enzalutamide treatment.

Trial design

This is a single-arm, multicenter, phase IIA clinical trial. Pts will receive radium-223 at a dose of 55 kBq per kilogram, given at 4-weeks intervals for 6 intravenous injections, until progression or unacceptable toxicity. We will screen for AR-V7 splice variant and CTCs number after inclusion, at the end of treatment and at progression. We predict that the number of AR-V7[+] pts will be 25% at inclusion. Major inclusion criteria are: (1) mCRPC according to standard Prostate Cancer Working Group (PCWG2)-2 criteria, (2) asymptomatic according to Brief Pain Inventory short form, (3) ≥24 weeks of prior treatment with abiraterone acetate or enzalutamide, (4) adequate organ function and performance status. The primary endpoint is the radiographic progression-free survival (rPFS) according to the PCWG-2 criteria. A total of 52 pts were predefined for the primary analysis using the one arm log-rank test. In both cohorts, we test the null hypothesis that true median rPFS is ≤ 3 months versus the alternative hypothesis that is ≥ 6.3 months. The one-sided type I error was 0.025 in both AR-V7 subgroups. A sample size of 13 pts is needed in the AR-V7[+] subgroup to attain 80% power. In accordance with the expected ratio between cohorts, we will include 39 pts in AR-V7[-] subgroup. The secondary objectives are to investigate the safety of the treatment, to determine the association between AR-V7 status and tumor response and to establish the relationship between circulating tumor cells number with radium-223 activity. Trial registration number is NCT03002220. Date of registration was 20/10/2016. First patient included on 20/12/2016.

Clinical trial identification

NCT03002220, Initial Release Date: 20/Oct/2016

Legal entity responsible for the study

Medica Scientia Innovation Research-MEDSIR

Funding

Bayer Hispania S.L.

Disclosure

M.A. Gonzalez Del Alba Baamonde: Advisory boards Bayer, Astellas, Sanofi, Janssen. Travel expenses: Astellas, Sanofi, Janssen. E. Gallardo Diaz: Advisory boards: Sanofi, Janssen, Astellas, Bayer, Roche, Pfizer. Honoraria: Astellas, Sanofi, Janssen. Travel expenses: Sanofi, Janssen, Astellas, Bayer, Pfizer. Clinical trials: Sanofi, Astellas, Bayer, Bavarian-Nordic, Roche, Pfizer. All other authors have declared no conflicts of interest.

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