Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy
Background Genomic classifiers (GC) have been shown to improve risk stratification post prostatectomy. However, their clinical benefit has not been prospectively demonstrated. We sought to determine the impact of GC testing on postoperative management in men with prostate cancer post prostatectomy....
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| Veröffentlicht in: | Prostate cancer and prostatic diseases 2020-06, Vol.23 (2), p.295-302 |
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| creator | Marascio, Joseph Spratt, Daniel E. Zhang, Jingbin Trabulsi, Edouard J. Le, Tiffany Sedzorme, Worlanyo Sosu Beeler, Whitney H. Davicioni, Elai Dabbas, Bashar Lin, Daniel W. Gore, John L. Bloom, Matthew Mann, Mark Mark, J. Ryan Calvaresi, Anne Godwin, James L. McCue, Peter Hurwitz, Mark D. Kelly, W. Kevin Lallas, Costas D. Knudsen, Karen E. Gomella, Leonard G. Dicker, Adam P. Den, Robert B. |
| description | Background
Genomic classifiers (GC) have been shown to improve risk stratification post prostatectomy. However, their clinical benefit has not been prospectively demonstrated. We sought to determine the impact of GC testing on postoperative management in men with prostate cancer post prostatectomy.
Methods
Two prospective registries of prostate cancer patients treated between 2014 and 2019 were included. All men underwent Decipher tumor testing for adverse features post prostatectomy (Decipher Biosciences, San Diego, CA). The clinical utility cohort, which measured the change in treatment decision-making, captured pre- and postgenomic treatment recommendations from urologists across diverse practice settings (
n
= 3455). The clinical benefit cohort, which examined the difference in outcome, was from a single academic institution whose tumor board predefined “best practices” based on GC results (
n
= 135).
Results
In the clinical utility cohort, providers’ recommendations pregenomic testing were primarily observation (69%). GC testing changed recommendations for 39% of patients, translating to a number needed to test of 3 to change one treatment decision. In the clinical benefit cohort, 61% of patients had genomic high-risk tumors; those who received the recommended adjuvant radiation therapy (ART) had 2-year PSA recurrence of 3 vs. 25% for those who did not (HR 0.1 [95% CI 0.0–0.6],
p
= 0.013). For the genomic low/intermediate-risk patients, 93% followed recommendations for observation, with similar 2-year PSA recurrence rates compared with those who received ART (
p
= 0.93).
Conclusions
The use of GC substantially altered treatment decision-making, with a number needed to test of only 3. Implementing best practices to routinely recommend ART for genomic-high patients led to larger than expected improvements in early biochemical endpoints, without jeopardizing outcomes for genomic-low/intermediate-risk patients. |
| doi_str_mv | 10.1038/s41391-019-0185-7 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7237345</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A624441320</galeid><sourcerecordid>A624441320</sourcerecordid><originalsourceid>FETCH-LOGICAL-c568t-b058d8d8374005296ffe79339d84b04740fec7fcefe232ce3386cc1c3be9bf9b3</originalsourceid><addsrcrecordid>eNp1Ul1r3TAMDWNj7br9gL0Mw2Bv6ezYcZyXQek-obA9bM8mceQbF8fOYqfl_vsp3K7thQ1hbKSjI0s6RfGa0XNGuXqfBOMtKylr8ai6bJ4Up0w0sqwlVU_xzSU6VV2dFC9SuqaUtqylz4sTzhrWSslPi_hjiWkGk90NkJTXYU9yJANYF4DkEYjxLjjTebJm513eky4MpIeAiEyiJR_BuHmEhWRI2YUdcYFMEIiN3sfbzTFjhdxlrBGn_cvime18gld391nx6_Onn5dfy6vvX75dXlyVppYqlz2t1YDGG0FpXbXSWmhazttBiZ4K9FowjTVgoeKVAc6VNIYZ3kPb27bnZ8WHA--89hMMBkJeOq_nxU3dstexc_o4Etyod_FGNxVvuKiR4O0dwRJ_r9ibvo7rEvDPuhJUyKpRij6gdp0H7YKNSGYml4y-kJUQuKBqQ53_A4U2wORM3GaJ_qOEd48SRuh8HlP0uIIY0jGQHYAGh5wWsPcdMqo3jeiDRjRqRG8a0Q3mvHk8mvuMv6JAQHUAJAyFHSwPrf-f9Q94Jsfz</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2404627880</pqid></control><display><type>article</type><title>Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Marascio, Joseph ; Spratt, Daniel E. ; Zhang, Jingbin ; Trabulsi, Edouard J. ; Le, Tiffany ; Sedzorme, Worlanyo Sosu ; Beeler, Whitney H. ; Davicioni, Elai ; Dabbas, Bashar ; Lin, Daniel W. ; Gore, John L. ; Bloom, Matthew ; Mann, Mark ; Mark, J. Ryan ; Calvaresi, Anne ; Godwin, James L. ; McCue, Peter ; Hurwitz, Mark D. ; Kelly, W. Kevin ; Lallas, Costas D. ; Knudsen, Karen E. ; Gomella, Leonard G. ; Dicker, Adam P. ; Den, Robert B.</creator><creatorcontrib>Marascio, Joseph ; Spratt, Daniel E. ; Zhang, Jingbin ; Trabulsi, Edouard J. ; Le, Tiffany ; Sedzorme, Worlanyo Sosu ; Beeler, Whitney H. ; Davicioni, Elai ; Dabbas, Bashar ; Lin, Daniel W. ; Gore, John L. ; Bloom, Matthew ; Mann, Mark ; Mark, J. Ryan ; Calvaresi, Anne ; Godwin, James L. ; McCue, Peter ; Hurwitz, Mark D. ; Kelly, W. Kevin ; Lallas, Costas D. ; Knudsen, Karen E. ; Gomella, Leonard G. ; Dicker, Adam P. ; Den, Robert B.</creatorcontrib><description>Background
Genomic classifiers (GC) have been shown to improve risk stratification post prostatectomy. However, their clinical benefit has not been prospectively demonstrated. We sought to determine the impact of GC testing on postoperative management in men with prostate cancer post prostatectomy.
Methods
Two prospective registries of prostate cancer patients treated between 2014 and 2019 were included. All men underwent Decipher tumor testing for adverse features post prostatectomy (Decipher Biosciences, San Diego, CA). The clinical utility cohort, which measured the change in treatment decision-making, captured pre- and postgenomic treatment recommendations from urologists across diverse practice settings (
n
= 3455). The clinical benefit cohort, which examined the difference in outcome, was from a single academic institution whose tumor board predefined “best practices” based on GC results (
n
= 135).
Results
In the clinical utility cohort, providers’ recommendations pregenomic testing were primarily observation (69%). GC testing changed recommendations for 39% of patients, translating to a number needed to test of 3 to change one treatment decision. In the clinical benefit cohort, 61% of patients had genomic high-risk tumors; those who received the recommended adjuvant radiation therapy (ART) had 2-year PSA recurrence of 3 vs. 25% for those who did not (HR 0.1 [95% CI 0.0–0.6],
p
= 0.013). For the genomic low/intermediate-risk patients, 93% followed recommendations for observation, with similar 2-year PSA recurrence rates compared with those who received ART (
p
= 0.93).
Conclusions
The use of GC substantially altered treatment decision-making, with a number needed to test of only 3. Implementing best practices to routinely recommend ART for genomic-high patients led to larger than expected improvements in early biochemical endpoints, without jeopardizing outcomes for genomic-low/intermediate-risk patients.</description><identifier>ISSN: 1365-7852</identifier><identifier>EISSN: 1476-5608</identifier><identifier>DOI: 10.1038/s41391-019-0185-7</identifier><identifier>PMID: 31719663</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>45/61 ; 692/53/2422 ; 692/699/67/1059 ; Adjuvant treatment ; Adult ; Aged ; Aged, 80 and over ; Algorithms ; Biomarkers, Tumor - genetics ; Biomedical and Life Sciences ; Biomedicine ; Cancer ; Cancer Research ; Cancer surgery ; Care and treatment ; Decision Making ; Follow-Up Studies ; Gene Expression Profiling ; Genomics ; Humans ; Male ; Middle Aged ; Patient Selection ; Patients ; Prognosis ; Prostate cancer ; Prostatectomy ; Prostatectomy - methods ; Prostatic Neoplasms - classification ; Prostatic Neoplasms - genetics ; Prostatic Neoplasms - pathology ; Prostatic Neoplasms - therapy ; Radiation ; Radiation therapy ; Radiotherapy ; Risk ; Risk Assessment - methods ; Surgery ; Survival Rate ; Tumors ; Urological surgery</subject><ispartof>Prostate cancer and prostatic diseases, 2020-06, Vol.23 (2), p.295-302</ispartof><rights>The Author(s) 2019</rights><rights>COPYRIGHT 2020 Nature Publishing Group</rights><rights>The Author(s) 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c568t-b058d8d8374005296ffe79339d84b04740fec7fcefe232ce3386cc1c3be9bf9b3</citedby><cites>FETCH-LOGICAL-c568t-b058d8d8374005296ffe79339d84b04740fec7fcefe232ce3386cc1c3be9bf9b3</cites><orcidid>0000-0002-1058-6493 ; 0000-0002-5973-4741 ; 0000-0003-0733-3337</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41391-019-0185-7$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41391-019-0185-7$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31719663$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Marascio, Joseph</creatorcontrib><creatorcontrib>Spratt, Daniel E.</creatorcontrib><creatorcontrib>Zhang, Jingbin</creatorcontrib><creatorcontrib>Trabulsi, Edouard J.</creatorcontrib><creatorcontrib>Le, Tiffany</creatorcontrib><creatorcontrib>Sedzorme, Worlanyo Sosu</creatorcontrib><creatorcontrib>Beeler, Whitney H.</creatorcontrib><creatorcontrib>Davicioni, Elai</creatorcontrib><creatorcontrib>Dabbas, Bashar</creatorcontrib><creatorcontrib>Lin, Daniel W.</creatorcontrib><creatorcontrib>Gore, John L.</creatorcontrib><creatorcontrib>Bloom, Matthew</creatorcontrib><creatorcontrib>Mann, Mark</creatorcontrib><creatorcontrib>Mark, J. Ryan</creatorcontrib><creatorcontrib>Calvaresi, Anne</creatorcontrib><creatorcontrib>Godwin, James L.</creatorcontrib><creatorcontrib>McCue, Peter</creatorcontrib><creatorcontrib>Hurwitz, Mark D.</creatorcontrib><creatorcontrib>Kelly, W. Kevin</creatorcontrib><creatorcontrib>Lallas, Costas D.</creatorcontrib><creatorcontrib>Knudsen, Karen E.</creatorcontrib><creatorcontrib>Gomella, Leonard G.</creatorcontrib><creatorcontrib>Dicker, Adam P.</creatorcontrib><creatorcontrib>Den, Robert B.</creatorcontrib><title>Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy</title><title>Prostate cancer and prostatic diseases</title><addtitle>Prostate Cancer Prostatic Dis</addtitle><addtitle>Prostate Cancer Prostatic Dis</addtitle><description>Background
Genomic classifiers (GC) have been shown to improve risk stratification post prostatectomy. However, their clinical benefit has not been prospectively demonstrated. We sought to determine the impact of GC testing on postoperative management in men with prostate cancer post prostatectomy.
Methods
Two prospective registries of prostate cancer patients treated between 2014 and 2019 were included. All men underwent Decipher tumor testing for adverse features post prostatectomy (Decipher Biosciences, San Diego, CA). The clinical utility cohort, which measured the change in treatment decision-making, captured pre- and postgenomic treatment recommendations from urologists across diverse practice settings (
n
= 3455). The clinical benefit cohort, which examined the difference in outcome, was from a single academic institution whose tumor board predefined “best practices” based on GC results (
n
= 135).
Results
In the clinical utility cohort, providers’ recommendations pregenomic testing were primarily observation (69%). GC testing changed recommendations for 39% of patients, translating to a number needed to test of 3 to change one treatment decision. In the clinical benefit cohort, 61% of patients had genomic high-risk tumors; those who received the recommended adjuvant radiation therapy (ART) had 2-year PSA recurrence of 3 vs. 25% for those who did not (HR 0.1 [95% CI 0.0–0.6],
p
= 0.013). For the genomic low/intermediate-risk patients, 93% followed recommendations for observation, with similar 2-year PSA recurrence rates compared with those who received ART (
p
= 0.93).
Conclusions
The use of GC substantially altered treatment decision-making, with a number needed to test of only 3. Implementing best practices to routinely recommend ART for genomic-high patients led to larger than expected improvements in early biochemical endpoints, without jeopardizing outcomes for genomic-low/intermediate-risk patients.</description><subject>45/61</subject><subject>692/53/2422</subject><subject>692/699/67/1059</subject><subject>Adjuvant treatment</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Algorithms</subject><subject>Biomarkers, Tumor - genetics</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Cancer surgery</subject><subject>Care and treatment</subject><subject>Decision Making</subject><subject>Follow-Up Studies</subject><subject>Gene Expression Profiling</subject><subject>Genomics</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patient Selection</subject><subject>Patients</subject><subject>Prognosis</subject><subject>Prostate cancer</subject><subject>Prostatectomy</subject><subject>Prostatectomy - methods</subject><subject>Prostatic Neoplasms - classification</subject><subject>Prostatic Neoplasms - genetics</subject><subject>Prostatic Neoplasms - pathology</subject><subject>Prostatic Neoplasms - therapy</subject><subject>Radiation</subject><subject>Radiation therapy</subject><subject>Radiotherapy</subject><subject>Risk</subject><subject>Risk Assessment - methods</subject><subject>Surgery</subject><subject>Survival Rate</subject><subject>Tumors</subject><subject>Urological surgery</subject><issn>1365-7852</issn><issn>1476-5608</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1Ul1r3TAMDWNj7br9gL0Mw2Bv6ezYcZyXQek-obA9bM8mceQbF8fOYqfl_vsp3K7thQ1hbKSjI0s6RfGa0XNGuXqfBOMtKylr8ai6bJ4Up0w0sqwlVU_xzSU6VV2dFC9SuqaUtqylz4sTzhrWSslPi_hjiWkGk90NkJTXYU9yJANYF4DkEYjxLjjTebJm513eky4MpIeAiEyiJR_BuHmEhWRI2YUdcYFMEIiN3sfbzTFjhdxlrBGn_cvime18gld391nx6_Onn5dfy6vvX75dXlyVppYqlz2t1YDGG0FpXbXSWmhazttBiZ4K9FowjTVgoeKVAc6VNIYZ3kPb27bnZ8WHA--89hMMBkJeOq_nxU3dstexc_o4Etyod_FGNxVvuKiR4O0dwRJ_r9ibvo7rEvDPuhJUyKpRij6gdp0H7YKNSGYml4y-kJUQuKBqQ53_A4U2wORM3GaJ_qOEd48SRuh8HlP0uIIY0jGQHYAGh5wWsPcdMqo3jeiDRjRqRG8a0Q3mvHk8mvuMv6JAQHUAJAyFHSwPrf-f9Q94Jsfz</recordid><startdate>20200601</startdate><enddate>20200601</enddate><creator>Marascio, Joseph</creator><creator>Spratt, Daniel E.</creator><creator>Zhang, Jingbin</creator><creator>Trabulsi, Edouard J.</creator><creator>Le, Tiffany</creator><creator>Sedzorme, Worlanyo Sosu</creator><creator>Beeler, Whitney H.</creator><creator>Davicioni, Elai</creator><creator>Dabbas, Bashar</creator><creator>Lin, Daniel W.</creator><creator>Gore, John L.</creator><creator>Bloom, Matthew</creator><creator>Mann, Mark</creator><creator>Mark, J. 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Ryan ; Calvaresi, Anne ; Godwin, James L. ; McCue, Peter ; Hurwitz, Mark D. ; Kelly, W. Kevin ; Lallas, Costas D. ; Knudsen, Karen E. ; Gomella, Leonard G. ; Dicker, Adam P. ; Den, Robert B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c568t-b058d8d8374005296ffe79339d84b04740fec7fcefe232ce3386cc1c3be9bf9b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>45/61</topic><topic>692/53/2422</topic><topic>692/699/67/1059</topic><topic>Adjuvant treatment</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Algorithms</topic><topic>Biomarkers, Tumor - genetics</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer</topic><topic>Cancer Research</topic><topic>Cancer surgery</topic><topic>Care and treatment</topic><topic>Decision Making</topic><topic>Follow-Up Studies</topic><topic>Gene Expression Profiling</topic><topic>Genomics</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patient Selection</topic><topic>Patients</topic><topic>Prognosis</topic><topic>Prostate cancer</topic><topic>Prostatectomy</topic><topic>Prostatectomy - methods</topic><topic>Prostatic Neoplasms - classification</topic><topic>Prostatic Neoplasms - genetics</topic><topic>Prostatic Neoplasms - pathology</topic><topic>Prostatic Neoplasms - therapy</topic><topic>Radiation</topic><topic>Radiation therapy</topic><topic>Radiotherapy</topic><topic>Risk</topic><topic>Risk Assessment - methods</topic><topic>Surgery</topic><topic>Survival Rate</topic><topic>Tumors</topic><topic>Urological surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Marascio, Joseph</creatorcontrib><creatorcontrib>Spratt, Daniel E.</creatorcontrib><creatorcontrib>Zhang, Jingbin</creatorcontrib><creatorcontrib>Trabulsi, Edouard J.</creatorcontrib><creatorcontrib>Le, Tiffany</creatorcontrib><creatorcontrib>Sedzorme, Worlanyo Sosu</creatorcontrib><creatorcontrib>Beeler, Whitney H.</creatorcontrib><creatorcontrib>Davicioni, Elai</creatorcontrib><creatorcontrib>Dabbas, Bashar</creatorcontrib><creatorcontrib>Lin, Daniel W.</creatorcontrib><creatorcontrib>Gore, John L.</creatorcontrib><creatorcontrib>Bloom, Matthew</creatorcontrib><creatorcontrib>Mann, Mark</creatorcontrib><creatorcontrib>Mark, J. 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Kevin</creatorcontrib><creatorcontrib>Lallas, Costas D.</creatorcontrib><creatorcontrib>Knudsen, Karen E.</creatorcontrib><creatorcontrib>Gomella, Leonard G.</creatorcontrib><creatorcontrib>Dicker, Adam P.</creatorcontrib><creatorcontrib>Den, Robert B.</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Prostate cancer and prostatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Marascio, Joseph</au><au>Spratt, Daniel E.</au><au>Zhang, Jingbin</au><au>Trabulsi, Edouard J.</au><au>Le, Tiffany</au><au>Sedzorme, Worlanyo Sosu</au><au>Beeler, Whitney H.</au><au>Davicioni, Elai</au><au>Dabbas, Bashar</au><au>Lin, Daniel W.</au><au>Gore, John L.</au><au>Bloom, Matthew</au><au>Mann, Mark</au><au>Mark, J. Ryan</au><au>Calvaresi, Anne</au><au>Godwin, James L.</au><au>McCue, Peter</au><au>Hurwitz, Mark D.</au><au>Kelly, W. Kevin</au><au>Lallas, Costas D.</au><au>Knudsen, Karen E.</au><au>Gomella, Leonard G.</au><au>Dicker, Adam P.</au><au>Den, Robert B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy</atitle><jtitle>Prostate cancer and prostatic diseases</jtitle><stitle>Prostate Cancer Prostatic Dis</stitle><addtitle>Prostate Cancer Prostatic Dis</addtitle><date>2020-06-01</date><risdate>2020</risdate><volume>23</volume><issue>2</issue><spage>295</spage><epage>302</epage><pages>295-302</pages><issn>1365-7852</issn><eissn>1476-5608</eissn><abstract>Background
Genomic classifiers (GC) have been shown to improve risk stratification post prostatectomy. However, their clinical benefit has not been prospectively demonstrated. We sought to determine the impact of GC testing on postoperative management in men with prostate cancer post prostatectomy.
Methods
Two prospective registries of prostate cancer patients treated between 2014 and 2019 were included. All men underwent Decipher tumor testing for adverse features post prostatectomy (Decipher Biosciences, San Diego, CA). The clinical utility cohort, which measured the change in treatment decision-making, captured pre- and postgenomic treatment recommendations from urologists across diverse practice settings (
n
= 3455). The clinical benefit cohort, which examined the difference in outcome, was from a single academic institution whose tumor board predefined “best practices” based on GC results (
n
= 135).
Results
In the clinical utility cohort, providers’ recommendations pregenomic testing were primarily observation (69%). GC testing changed recommendations for 39% of patients, translating to a number needed to test of 3 to change one treatment decision. In the clinical benefit cohort, 61% of patients had genomic high-risk tumors; those who received the recommended adjuvant radiation therapy (ART) had 2-year PSA recurrence of 3 vs. 25% for those who did not (HR 0.1 [95% CI 0.0–0.6],
p
= 0.013). For the genomic low/intermediate-risk patients, 93% followed recommendations for observation, with similar 2-year PSA recurrence rates compared with those who received ART (
p
= 0.93).
Conclusions
The use of GC substantially altered treatment decision-making, with a number needed to test of only 3. Implementing best practices to routinely recommend ART for genomic-high patients led to larger than expected improvements in early biochemical endpoints, without jeopardizing outcomes for genomic-low/intermediate-risk patients.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>31719663</pmid><doi>10.1038/s41391-019-0185-7</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-1058-6493</orcidid><orcidid>https://orcid.org/0000-0002-5973-4741</orcidid><orcidid>https://orcid.org/0000-0003-0733-3337</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1365-7852 |
| ispartof | Prostate cancer and prostatic diseases, 2020-06, Vol.23 (2), p.295-302 |
| issn | 1365-7852 1476-5608 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7237345 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | 45/61 692/53/2422 692/699/67/1059 Adjuvant treatment Adult Aged Aged, 80 and over Algorithms Biomarkers, Tumor - genetics Biomedical and Life Sciences Biomedicine Cancer Cancer Research Cancer surgery Care and treatment Decision Making Follow-Up Studies Gene Expression Profiling Genomics Humans Male Middle Aged Patient Selection Patients Prognosis Prostate cancer Prostatectomy Prostatectomy - methods Prostatic Neoplasms - classification Prostatic Neoplasms - genetics Prostatic Neoplasms - pathology Prostatic Neoplasms - therapy Radiation Radiation therapy Radiotherapy Risk Risk Assessment - methods Surgery Survival Rate Tumors Urological surgery |
| title | Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T19%3A21%3A00IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Prospective%20study%20to%20define%20the%20clinical%20utility%20and%20benefit%20of%20Decipher%20testing%20in%20men%20following%20prostatectomy&rft.jtitle=Prostate%20cancer%20and%20prostatic%20diseases&rft.au=Marascio,%20Joseph&rft.date=2020-06-01&rft.volume=23&rft.issue=2&rft.spage=295&rft.epage=302&rft.pages=295-302&rft.issn=1365-7852&rft.eissn=1476-5608&rft_id=info:doi/10.1038/s41391-019-0185-7&rft_dat=%3Cgale_pubme%3EA624441320%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2404627880&rft_id=info:pmid/31719663&rft_galeid=A624441320&rfr_iscdi=true |