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The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP).

Publication ,  Journal Article
ICECaP Working Group, ; Sweeney, C; Nakabayashi, M; Regan, M; Xie, W; Hayes, J; Keating, N; Li, S; Philipson, T; Buyse, M; Halabi, S; Soule, H ...
Published in: J Natl Cancer Inst
December 2015

New systemic therapies have prolonged the lives of men with metastatic castration-resistant prostate cancer (mCRPC). Use of these therapies in the adjuvant setting when the disease may be micrometastatic and potentially more sensitive to therapies may decrease mortality from prostate cancer. However, the conduct of adjuvant prostate cancer clinical trials is hampered by taking longer than a decade to reach the meaningful endpoint of overall survival (OS) and the fact that many men never die from prostate cancer, even if they relapse. A validated intermediate clinical endpoint (ICE) in prostate cancer that is a robust surrogate for OS has yet to be defined. This paper details the plans, process, and progress of the international Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) working group to pool individual patient data from all available clinical trials of radiation or prostatectomy for localized disease and conduct the requisite analyses to determine whether an ICE can be identified. This paper further details the challenges and the a priori statistical analytical plans and strategies to define an ICE for adjuvant prostate cancer clinical trials. In addition, a brief review of the health economic analyses to model the benefits to patients, society and manufacturers is detailed. If successful, the results from this work will provide a robust surrogate for OS that will expedite the design and conduct of future adjuvant therapy trials using new agents that have proven activity in mCRPC. Moreover, it will also define the health economic benefits to patients and societies.

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Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

December 2015

Volume

107

Issue

12

Start / End Page

djv261

Location

United States

Related Subject Headings

  • United States
  • Treatment Failure
  • Time Factors
  • Statistics as Topic
  • Randomized Controlled Trials as Topic
  • Radiotherapy, Adjuvant
  • Prostatic Neoplasms, Castration-Resistant
  • Prostatectomy
  • Prostate-Specific Antigen
  • Oncology & Carcinogenesis
 

Citation

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ICECaP Working Group, ., Sweeney, C., Nakabayashi, M., Regan, M., Xie, W., Hayes, J., … Mahal, B. (2015). The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP). J Natl Cancer Inst, 107(12), djv261. https://doi.org/10.1093/jnci/djv261
ICECaP Working Group, Brandon, Christopher Sweeney, Mari Nakabayashi, Meredith Regan, Wanling Xie, Julia Hayes, Nancy Keating, et al. “The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP).J Natl Cancer Inst 107, no. 12 (December 2015): djv261. https://doi.org/10.1093/jnci/djv261.
ICECaP Working Group, Sweeney C, Nakabayashi M, Regan M, Xie W, Hayes J, et al. The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP). J Natl Cancer Inst. 2015 Dec;107(12):djv261.
ICECaP Working Group, Brandon, et al. “The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP).J Natl Cancer Inst, vol. 107, no. 12, Dec. 2015, p. djv261. Pubmed, doi:10.1093/jnci/djv261.
ICECaP Working Group, Sweeney C, Nakabayashi M, Regan M, Xie W, Hayes J, Keating N, Li S, Philipson T, Buyse M, Halabi S, Kantoff P, Sartor AO, Soule H, Mahal B. The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP). J Natl Cancer Inst. 2015 Dec;107(12):djv261.
Journal cover image

Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

December 2015

Volume

107

Issue

12

Start / End Page

djv261

Location

United States

Related Subject Headings

  • United States
  • Treatment Failure
  • Time Factors
  • Statistics as Topic
  • Randomized Controlled Trials as Topic
  • Radiotherapy, Adjuvant
  • Prostatic Neoplasms, Castration-Resistant
  • Prostatectomy
  • Prostate-Specific Antigen
  • Oncology & Carcinogenesis