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Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.

Publication ,  Journal Article
Scher, HI; Morris, MJ; Stadler, WM; Higano, C; Basch, E; Fizazi, K; Antonarakis, ES; Beer, TM; Carducci, MA; Chi, KN; Corn, PG; de Bono, JS ...
Published in: J Clin Oncol
April 20, 2016

PURPOSE: Evolving treatments, disease phenotypes, and biology, together with a changing drug development environment, have created the need to revise castration-resistant prostate cancer (CRPC) clinical trial recommendations to succeed those from prior Prostate Cancer Clinical Trials Working Groups. METHODS: An international expert committee of prostate cancer clinical investigators (the Prostate Cancer Clinical Trials Working Group 3 [PCWG3]) was reconvened and expanded and met in 2012-2015 to formulate updated criteria on the basis of emerging trial data and validation studies of the Prostate Cancer Clinical Trials Working Group 2 recommendations. RESULTS: PCWG3 recommends that baseline patient assessment include tumor histology, detailed records of prior systemic treatments and responses, and a detailed reporting of disease subtypes based on an anatomic pattern of metastatic spread. New recommendations for trial outcome measures include the time to event end point of symptomatic skeletal events, as well as time to first metastasis and time to progression for trials in the nonmetastatic CRPC state. PCWG3 introduces the concept of no longer clinically benefiting to underscore the distinction between first evidence of progression and the clinical need to terminate or change treatment, and the importance of documenting progression in existing lesions as distinct from the development of new lesions. Serial biologic profiling using tumor samples from biopsies, blood-based diagnostics, and/or imaging is also recommended to gain insight into mechanisms of resistance and to identify predictive biomarkers of sensitivity for use in prospective trials. CONCLUSION: PCWG3 moves drug development closer to unmet needs in clinical practice by focusing on disease manifestations most likely to affect prognosis adversely for therapeutics tested in both nonmetastatic and metastatic CRPC populations. Consultation with regulatory authorities is recommended if a trial is intended to seek support for drug approval.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

April 20, 2016

Volume

34

Issue

12

Start / End Page

1402 / 1418

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Surveys and Questionnaires
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Prostatic Neoplasms, Castration-Resistant
  • Prostate-Specific Antigen
  • Predictive Value of Tests
  • Phenotype
 

Citation

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Scher, H. I., Morris, M. J., Stadler, W. M., Higano, C., Basch, E., Fizazi, K., … Prostate Cancer Clinical Trials Working Group 3, . (2016). Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol, 34(12), 1402–1418. https://doi.org/10.1200/JCO.2015.64.2702
Scher, Howard I., Michael J. Morris, Walter M. Stadler, Celestia Higano, Ethan Basch, Karim Fizazi, Emmanuel S. Antonarakis, et al. “Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.J Clin Oncol 34, no. 12 (April 20, 2016): 1402–18. https://doi.org/10.1200/JCO.2015.64.2702.
Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, et al. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402–18.
Scher, Howard I., et al. “Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.J Clin Oncol, vol. 34, no. 12, Apr. 2016, pp. 1402–18. Pubmed, doi:10.1200/JCO.2015.64.2702.
Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin M-E, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, Armstrong AJ, Prostate Cancer Clinical Trials Working Group 3. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402–1418.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

April 20, 2016

Volume

34

Issue

12

Start / End Page

1402 / 1418

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Surveys and Questionnaires
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Prostatic Neoplasms, Castration-Resistant
  • Prostate-Specific Antigen
  • Predictive Value of Tests
  • Phenotype