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The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP).
- Source :
- JNCI: Journal of the National Cancer Institute; Dec2015, Vol. 107 Issue 12, p1-8, 8p, 1 Diagram, 2 Charts
- Publication Year :
- 2015
-
Abstract
- 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- PROSTATE tumors treatment
ANTINEOPLASTIC agents
COMBINED modality therapy
CANCER relapse
CLINICAL trials
COST effectiveness
EXPERIMENTAL design
LONGEVITY
RESEARCH methodology
MEDICAL cooperation
MEN'S health
META-analysis
PROGNOSIS
PROSTATE tumors
PROSTATECTOMY
RADIOTHERAPY
RESEARCH
STATISTICS
SURVIVAL
TIME
DECISION making in clinical medicine
TREATMENT effectiveness
DISEASE progression
ECONOMICS
Subjects
Details
- Language :
- English
- ISSN :
- 00278874
- Volume :
- 107
- Issue :
- 12
- Database :
- Complementary Index
- Journal :
- JNCI: Journal of the National Cancer Institute
- Publication Type :
- Academic Journal
- Accession number :
- 111875450
- Full Text :
- https://doi.org/10.1093/jnci/djv261