The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP)
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...
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| creator | Sweeney, Christopher Nakabayashi, Mari Regan, Meredith Xie, Wanling Hayes, Julia Keating, Nancy Li, Suhui Philipson, Tomas Buyse, Marc Halabi, Susan Kantoff, Philip Sartor, A Oliver Soule, Howard Mahal, Brandon |
| description | 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. |
| doi_str_mv | 10.1093/jnci/djv261 |
| format | Article |
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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.</description><identifier>ISSN: 0027-8874</identifier><identifier>EISSN: 1460-2105</identifier><identifier>DOI: 10.1093/jnci/djv261</identifier><identifier>PMID: 26409187</identifier><identifier>CODEN: JNCIEQ</identifier><language>eng</language><publisher>United States: Oxford Publishing Limited (England)</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - economics ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biomarkers, Tumor - blood ; Chemotherapy, Adjuvant - economics ; Clinical trials ; Cost-Benefit Analysis ; Disease Progression ; Disease-Free Survival ; Endpoint Determination - methods ; Endpoint Determination - standards ; Endpoint Determination - trends ; Health economics ; Humans ; Longevity ; Male ; Mortality ; Multicenter Studies as Topic ; Neoplasm Recurrence, Local ; Prostate cancer ; Prostate-Specific Antigen - blood ; Prostatectomy ; Prostatic Neoplasms, Castration-Resistant - blood ; Prostatic Neoplasms, Castration-Resistant - economics ; Prostatic Neoplasms, Castration-Resistant - therapy ; Radiotherapy, Adjuvant - economics ; Randomized Controlled Trials as Topic ; Statistics as Topic ; Survival analysis ; Time Factors ; Treatment Failure ; United States</subject><ispartof>JNCI : Journal of the National Cancer Institute, 2015-12, Vol.107 (12), p.djv261-djv261</ispartof><rights>The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</rights><rights>Copyright Oxford Publishing Limited(England) Dec 2015</rights><rights>The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-30691b983f68099bc2d1ed0b7c904fc63fe6ca715ce5b41df9eae1674fff7b903</citedby><cites>FETCH-LOGICAL-c479t-30691b983f68099bc2d1ed0b7c904fc63fe6ca715ce5b41df9eae1674fff7b903</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26409187$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sweeney, Christopher</creatorcontrib><creatorcontrib>Nakabayashi, Mari</creatorcontrib><creatorcontrib>Regan, Meredith</creatorcontrib><creatorcontrib>Xie, Wanling</creatorcontrib><creatorcontrib>Hayes, Julia</creatorcontrib><creatorcontrib>Keating, Nancy</creatorcontrib><creatorcontrib>Li, Suhui</creatorcontrib><creatorcontrib>Philipson, Tomas</creatorcontrib><creatorcontrib>Buyse, Marc</creatorcontrib><creatorcontrib>Halabi, Susan</creatorcontrib><creatorcontrib>Kantoff, Philip</creatorcontrib><creatorcontrib>Sartor, A Oliver</creatorcontrib><creatorcontrib>Soule, Howard</creatorcontrib><creatorcontrib>Mahal, Brandon</creatorcontrib><creatorcontrib>ICECaP Working Group</creatorcontrib><title>The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP)</title><title>JNCI : Journal of the National Cancer Institute</title><addtitle>J Natl Cancer Inst</addtitle><description>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. 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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><cop>United States</cop><pub>Oxford Publishing Limited (England)</pub><pmid>26409187</pmid><doi>10.1093/jnci/djv261</doi><oa>free_for_read</oa></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Antineoplastic Combined Chemotherapy Protocols - economics Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biomarkers, Tumor - blood Chemotherapy, Adjuvant - economics Clinical trials Cost-Benefit Analysis Disease Progression Disease-Free Survival Endpoint Determination - methods Endpoint Determination - standards Endpoint Determination - trends Health economics Humans Longevity Male Mortality Multicenter Studies as Topic Neoplasm Recurrence, Local Prostate cancer Prostate-Specific Antigen - blood Prostatectomy Prostatic Neoplasms, Castration-Resistant - blood Prostatic Neoplasms, Castration-Resistant - economics Prostatic Neoplasms, Castration-Resistant - therapy Radiotherapy, Adjuvant - economics Randomized Controlled Trials as Topic Statistics as Topic Survival analysis Time Factors Treatment Failure United States |
| title | The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) |
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