99mTcPSMA‐radioguided surgery in oligorecurrent prostate cancer: the randomised TRACE‐II trial
Objective To investigate whether combination treatment of prostate‐specific membrane antigen (PSMA)‐based radioguided surgery (RGS) with short‐term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) as compared to treatment with short‐te...
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| Veröffentlicht in: | BJU international 2024-07, Vol.134 (1), p.81-88 |
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| creator | Zuur, Lotte G. Barros, Hilda A. Oosterom, Matthias N. Berrens, Anne‐Claire Donswijk, Maarten L. Hendrikx, Jeroen J.M.A. Bekers, Elise M. Vis, André N. Wit, Esther M. Leeuwen, Fijs B. Poel, Henk G. Leeuwen, Pim J. |
| description | Objective
To investigate whether combination treatment of prostate‐specific membrane antigen (PSMA)‐based radioguided surgery (RGS) with short‐term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) as compared to treatment with short‐term ADT only.
Methods
The TRACE‐II study is an investigator‐initiated, prospective, randomised controlled clinical trial. Patients (aged >18 years) with hormone‐sensitive recurrent PCa after radical prostatectomy or radiotherapy (brachytherapy or external beam radiotherapy), with involvement of ≤2 lymph nodes or local oligorecurrent disease within the pelvis as determined by PSMA positron emission tomography (PET)/computed tomography (CT) are randomly assigned in a 1:1 ratio between 6‐month ADT (Arm A) or 6‐month ADT plus RGS (Arm B). The primary objective is to determine clinical progression‐free survival (CPFS) at 24 months. After PSMA‐RGS, CPFS is defined as the time between the start of treatment and the appearance of a re‐recurrence (any N1 or M1) as suggested by PSMA‐PET/CT or symptoms related to progressive PCa, or death from any cause. The secondary objectives include metastasis‐free survival at 2, 5 and 10 years, biochemical progression‐free survival at 2 years, and patient‐reported quality of life at 2, 5 and 10 years. A total of 60 patients, 30 per arm, will be included. The trial is powered (80%) to detect at least a 30% absolute difference in CPFS between the two study arms in the period 2 years after randomisation. We expect to enrol the required participants in 3 years. The study has an expected duration of 5 years in total.
Conclusions
Combining RGS with short‐term ADT might be oncologically beneficial for patients with oligorecurrent PCa. In this first randomised controlled trial, we are investigating the potential oncological benefits of this combined treatment, while also focusing on maintaining quality of life. |
| doi_str_mv | 10.1111/bju.16297 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_wiley</sourceid><recordid>TN_cdi_proquest_miscellaneous_2926079837</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2926079837</sourcerecordid><originalsourceid>FETCH-LOGICAL-p1867-acccae581c7627323d76fdb6e7a594a6cad8f5e5cf9da0d9a1817ba914e44c1e3</originalsourceid><addsrcrecordid>eNpdkM1KAzEUhYMoWKsL3yDgxs20yfwkE3e1VK1UFG3BXcgktzVlOlOTGaQ7H8Fn9ElMW914N_dw-e7hcBA6p6RHw_SLZdujLBb8AHVoytIopeT18E8TwY7RifdLQsKBZR1UCLGa6qeXh8H355dTxtaL1how2LduAW6DbYXr0i5qB7p1DqoGr13tG9UA1qrS4K5w8wbYqcrUK-vD5_R5MBwFt_EYN86q8hQdzVXp4ex3d9HsZjQd3kWTx9vxcDCJ1jRnPFJaawVZTjVnMU_ixHA2NwUDrjKRKqaVyecZZHoujCJGKJpTXihBU0hTTSHposu9bwj43oJvZMijoSxVBXXrZSxiRrjIEx7Qi3_osm5dFdLJhDCRkFywLdXfUx-2hI1cO7tSbiMpkduqZaha7qqW1_eznUh-ALjZdcE</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3069308967</pqid></control><display><type>article</type><title>99mTcPSMA‐radioguided surgery in oligorecurrent prostate cancer: the randomised TRACE‐II trial</title><source>Access via Wiley Online Library</source><creator>Zuur, Lotte G. ; Barros, Hilda A. ; Oosterom, Matthias N. ; Berrens, Anne‐Claire ; Donswijk, Maarten L. ; Hendrikx, Jeroen J.M.A. ; Bekers, Elise M. ; Vis, André N. ; Wit, Esther M. ; Leeuwen, Fijs B. ; Poel, Henk G. ; Leeuwen, Pim J.</creator><creatorcontrib>Zuur, Lotte G. ; Barros, Hilda A. ; Oosterom, Matthias N. ; Berrens, Anne‐Claire ; Donswijk, Maarten L. ; Hendrikx, Jeroen J.M.A. ; Bekers, Elise M. ; Vis, André N. ; Wit, Esther M. ; Leeuwen, Fijs B. ; Poel, Henk G. ; Leeuwen, Pim J.</creatorcontrib><description>Objective
To investigate whether combination treatment of prostate‐specific membrane antigen (PSMA)‐based radioguided surgery (RGS) with short‐term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) as compared to treatment with short‐term ADT only.
Methods
The TRACE‐II study is an investigator‐initiated, prospective, randomised controlled clinical trial. Patients (aged >18 years) with hormone‐sensitive recurrent PCa after radical prostatectomy or radiotherapy (brachytherapy or external beam radiotherapy), with involvement of ≤2 lymph nodes or local oligorecurrent disease within the pelvis as determined by PSMA positron emission tomography (PET)/computed tomography (CT) are randomly assigned in a 1:1 ratio between 6‐month ADT (Arm A) or 6‐month ADT plus RGS (Arm B). The primary objective is to determine clinical progression‐free survival (CPFS) at 24 months. After PSMA‐RGS, CPFS is defined as the time between the start of treatment and the appearance of a re‐recurrence (any N1 or M1) as suggested by PSMA‐PET/CT or symptoms related to progressive PCa, or death from any cause. The secondary objectives include metastasis‐free survival at 2, 5 and 10 years, biochemical progression‐free survival at 2 years, and patient‐reported quality of life at 2, 5 and 10 years. A total of 60 patients, 30 per arm, will be included. The trial is powered (80%) to detect at least a 30% absolute difference in CPFS between the two study arms in the period 2 years after randomisation. We expect to enrol the required participants in 3 years. The study has an expected duration of 5 years in total.
Conclusions
Combining RGS with short‐term ADT might be oncologically beneficial for patients with oligorecurrent PCa. In this first randomised controlled trial, we are investigating the potential oncological benefits of this combined treatment, while also focusing on maintaining quality of life.</description><identifier>ISSN: 1464-4096</identifier><identifier>ISSN: 1464-410X</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/bju.16297</identifier><language>eng</language><publisher>Edgecliff: Wiley Subscription Services, Inc</publisher><subject>99mTcPSMA ; androgen deprivation therapy ; Brachytherapy ; Computed tomography ; Lymph nodes ; Metastases ; oligorecurrent ; Patients ; Pelvis ; Positron emission tomography ; Prostate cancer ; prostate specific membrane antigen ; Prostatectomy ; Quality of life ; Radiation therapy ; radioguided surgery ; Surgery ; Survival ; Tomography</subject><ispartof>BJU international, 2024-07, Vol.134 (1), p.81-88</ispartof><rights>2024 BJU International.</rights><rights>Copyright © 2024 BJU International</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0002-8772-1120 ; 0009-0000-7392-1626 ; 0000-0003-2102-7897</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbju.16297$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbju.16297$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids></links><search><creatorcontrib>Zuur, Lotte G.</creatorcontrib><creatorcontrib>Barros, Hilda A.</creatorcontrib><creatorcontrib>Oosterom, Matthias N.</creatorcontrib><creatorcontrib>Berrens, Anne‐Claire</creatorcontrib><creatorcontrib>Donswijk, Maarten L.</creatorcontrib><creatorcontrib>Hendrikx, Jeroen J.M.A.</creatorcontrib><creatorcontrib>Bekers, Elise M.</creatorcontrib><creatorcontrib>Vis, André N.</creatorcontrib><creatorcontrib>Wit, Esther M.</creatorcontrib><creatorcontrib>Leeuwen, Fijs B.</creatorcontrib><creatorcontrib>Poel, Henk G.</creatorcontrib><creatorcontrib>Leeuwen, Pim J.</creatorcontrib><title>99mTcPSMA‐radioguided surgery in oligorecurrent prostate cancer: the randomised TRACE‐II trial</title><title>BJU international</title><description>Objective
To investigate whether combination treatment of prostate‐specific membrane antigen (PSMA)‐based radioguided surgery (RGS) with short‐term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) as compared to treatment with short‐term ADT only.
Methods
The TRACE‐II study is an investigator‐initiated, prospective, randomised controlled clinical trial. Patients (aged >18 years) with hormone‐sensitive recurrent PCa after radical prostatectomy or radiotherapy (brachytherapy or external beam radiotherapy), with involvement of ≤2 lymph nodes or local oligorecurrent disease within the pelvis as determined by PSMA positron emission tomography (PET)/computed tomography (CT) are randomly assigned in a 1:1 ratio between 6‐month ADT (Arm A) or 6‐month ADT plus RGS (Arm B). The primary objective is to determine clinical progression‐free survival (CPFS) at 24 months. After PSMA‐RGS, CPFS is defined as the time between the start of treatment and the appearance of a re‐recurrence (any N1 or M1) as suggested by PSMA‐PET/CT or symptoms related to progressive PCa, or death from any cause. The secondary objectives include metastasis‐free survival at 2, 5 and 10 years, biochemical progression‐free survival at 2 years, and patient‐reported quality of life at 2, 5 and 10 years. A total of 60 patients, 30 per arm, will be included. The trial is powered (80%) to detect at least a 30% absolute difference in CPFS between the two study arms in the period 2 years after randomisation. We expect to enrol the required participants in 3 years. The study has an expected duration of 5 years in total.
Conclusions
Combining RGS with short‐term ADT might be oncologically beneficial for patients with oligorecurrent PCa. In this first randomised controlled trial, we are investigating the potential oncological benefits of this combined treatment, while also focusing on maintaining quality of life.</description><subject>99mTcPSMA</subject><subject>androgen deprivation therapy</subject><subject>Brachytherapy</subject><subject>Computed tomography</subject><subject>Lymph nodes</subject><subject>Metastases</subject><subject>oligorecurrent</subject><subject>Patients</subject><subject>Pelvis</subject><subject>Positron emission tomography</subject><subject>Prostate cancer</subject><subject>prostate specific membrane antigen</subject><subject>Prostatectomy</subject><subject>Quality of life</subject><subject>Radiation therapy</subject><subject>radioguided surgery</subject><subject>Surgery</subject><subject>Survival</subject><subject>Tomography</subject><issn>1464-4096</issn><issn>1464-410X</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpdkM1KAzEUhYMoWKsL3yDgxs20yfwkE3e1VK1UFG3BXcgktzVlOlOTGaQ7H8Fn9ElMW914N_dw-e7hcBA6p6RHw_SLZdujLBb8AHVoytIopeT18E8TwY7RifdLQsKBZR1UCLGa6qeXh8H355dTxtaL1how2LduAW6DbYXr0i5qB7p1DqoGr13tG9UA1qrS4K5w8wbYqcrUK-vD5_R5MBwFt_EYN86q8hQdzVXp4ex3d9HsZjQd3kWTx9vxcDCJ1jRnPFJaawVZTjVnMU_ixHA2NwUDrjKRKqaVyecZZHoujCJGKJpTXihBU0hTTSHposu9bwj43oJvZMijoSxVBXXrZSxiRrjIEx7Qi3_osm5dFdLJhDCRkFywLdXfUx-2hI1cO7tSbiMpkduqZaha7qqW1_eznUh-ALjZdcE</recordid><startdate>202407</startdate><enddate>202407</enddate><creator>Zuur, Lotte G.</creator><creator>Barros, Hilda A.</creator><creator>Oosterom, Matthias N.</creator><creator>Berrens, Anne‐Claire</creator><creator>Donswijk, Maarten L.</creator><creator>Hendrikx, Jeroen J.M.A.</creator><creator>Bekers, Elise M.</creator><creator>Vis, André N.</creator><creator>Wit, Esther M.</creator><creator>Leeuwen, Fijs B.</creator><creator>Poel, Henk G.</creator><creator>Leeuwen, Pim J.</creator><general>Wiley Subscription Services, Inc</general><scope>7QP</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-8772-1120</orcidid><orcidid>https://orcid.org/0009-0000-7392-1626</orcidid><orcidid>https://orcid.org/0000-0003-2102-7897</orcidid></search><sort><creationdate>202407</creationdate><title>99mTcPSMA‐radioguided surgery in oligorecurrent prostate cancer: the randomised TRACE‐II trial</title><author>Zuur, Lotte G. ; Barros, Hilda A. ; Oosterom, Matthias N. ; Berrens, Anne‐Claire ; Donswijk, Maarten L. ; Hendrikx, Jeroen J.M.A. ; Bekers, Elise M. ; Vis, André N. ; Wit, Esther M. ; Leeuwen, Fijs B. ; Poel, Henk G. ; Leeuwen, Pim J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p1867-acccae581c7627323d76fdb6e7a594a6cad8f5e5cf9da0d9a1817ba914e44c1e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>99mTcPSMA</topic><topic>androgen deprivation therapy</topic><topic>Brachytherapy</topic><topic>Computed tomography</topic><topic>Lymph nodes</topic><topic>Metastases</topic><topic>oligorecurrent</topic><topic>Patients</topic><topic>Pelvis</topic><topic>Positron emission tomography</topic><topic>Prostate cancer</topic><topic>prostate specific membrane antigen</topic><topic>Prostatectomy</topic><topic>Quality of life</topic><topic>Radiation therapy</topic><topic>radioguided surgery</topic><topic>Surgery</topic><topic>Survival</topic><topic>Tomography</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zuur, Lotte G.</creatorcontrib><creatorcontrib>Barros, Hilda A.</creatorcontrib><creatorcontrib>Oosterom, Matthias N.</creatorcontrib><creatorcontrib>Berrens, Anne‐Claire</creatorcontrib><creatorcontrib>Donswijk, Maarten L.</creatorcontrib><creatorcontrib>Hendrikx, Jeroen J.M.A.</creatorcontrib><creatorcontrib>Bekers, Elise M.</creatorcontrib><creatorcontrib>Vis, André N.</creatorcontrib><creatorcontrib>Wit, Esther M.</creatorcontrib><creatorcontrib>Leeuwen, Fijs B.</creatorcontrib><creatorcontrib>Poel, Henk G.</creatorcontrib><creatorcontrib>Leeuwen, Pim J.</creatorcontrib><collection>Calcium & Calcified Tissue Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zuur, Lotte G.</au><au>Barros, Hilda A.</au><au>Oosterom, Matthias N.</au><au>Berrens, Anne‐Claire</au><au>Donswijk, Maarten L.</au><au>Hendrikx, Jeroen J.M.A.</au><au>Bekers, Elise M.</au><au>Vis, André N.</au><au>Wit, Esther M.</au><au>Leeuwen, Fijs B.</au><au>Poel, Henk G.</au><au>Leeuwen, Pim J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>99mTcPSMA‐radioguided surgery in oligorecurrent prostate cancer: the randomised TRACE‐II trial</atitle><jtitle>BJU international</jtitle><date>2024-07</date><risdate>2024</risdate><volume>134</volume><issue>1</issue><spage>81</spage><epage>88</epage><pages>81-88</pages><issn>1464-4096</issn><issn>1464-410X</issn><eissn>1464-410X</eissn><abstract>Objective
To investigate whether combination treatment of prostate‐specific membrane antigen (PSMA)‐based radioguided surgery (RGS) with short‐term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) as compared to treatment with short‐term ADT only.
Methods
The TRACE‐II study is an investigator‐initiated, prospective, randomised controlled clinical trial. Patients (aged >18 years) with hormone‐sensitive recurrent PCa after radical prostatectomy or radiotherapy (brachytherapy or external beam radiotherapy), with involvement of ≤2 lymph nodes or local oligorecurrent disease within the pelvis as determined by PSMA positron emission tomography (PET)/computed tomography (CT) are randomly assigned in a 1:1 ratio between 6‐month ADT (Arm A) or 6‐month ADT plus RGS (Arm B). The primary objective is to determine clinical progression‐free survival (CPFS) at 24 months. After PSMA‐RGS, CPFS is defined as the time between the start of treatment and the appearance of a re‐recurrence (any N1 or M1) as suggested by PSMA‐PET/CT or symptoms related to progressive PCa, or death from any cause. The secondary objectives include metastasis‐free survival at 2, 5 and 10 years, biochemical progression‐free survival at 2 years, and patient‐reported quality of life at 2, 5 and 10 years. A total of 60 patients, 30 per arm, will be included. The trial is powered (80%) to detect at least a 30% absolute difference in CPFS between the two study arms in the period 2 years after randomisation. We expect to enrol the required participants in 3 years. The study has an expected duration of 5 years in total.
Conclusions
Combining RGS with short‐term ADT might be oncologically beneficial for patients with oligorecurrent PCa. In this first randomised controlled trial, we are investigating the potential oncological benefits of this combined treatment, while also focusing on maintaining quality of life.</abstract><cop>Edgecliff</cop><pub>Wiley Subscription Services, Inc</pub><doi>10.1111/bju.16297</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-8772-1120</orcidid><orcidid>https://orcid.org/0009-0000-7392-1626</orcidid><orcidid>https://orcid.org/0000-0003-2102-7897</orcidid></addata></record> |
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| subjects | 99mTcPSMA androgen deprivation therapy Brachytherapy Computed tomography Lymph nodes Metastases oligorecurrent Patients Pelvis Positron emission tomography Prostate cancer prostate specific membrane antigen Prostatectomy Quality of life Radiation therapy radioguided surgery Surgery Survival Tomography |
| title | 99mTcPSMA‐radioguided surgery in oligorecurrent prostate cancer: the randomised TRACE‐II trial |
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