Carmen González-San Segundo, Fernando López Campos, Alfonso Gómez Iturriaga, Aurora Rodríguez, Jesús Olivera, Víctor Duque-Santana, Gemma Sancho, Iván Henríquez, Antonio José Conde, Jeannette Valero, Xavier Maldonado, Luis Glaria, Begoña Caballero, Noelia Sanmamed, Joel Mases, Anna María Boladeras-Inglada, Miguel Montijano, Marina Santos, Ana Álvarez, Juan I. Martínez, Felipe Couñago
{"title":"针对根治性前列腺切除术后生化治疗失败的短期与长期雄激素剥夺及挽救性放疗随机试验：URONCOR 06-24。","authors":"Carmen González-San Segundo, Fernando López Campos, Alfonso Gómez Iturriaga, Aurora Rodríguez, Jesús Olivera, Víctor Duque-Santana, Gemma Sancho, Iván Henríquez, Antonio José Conde, Jeannette Valero, Xavier Maldonado, Luis Glaria, Begoña Caballero, Noelia Sanmamed, Joel Mases, Anna María Boladeras-Inglada, Miguel Montijano, Marina Santos, Ana Álvarez, Juan I. Martínez, Felipe Couñago","doi":"10.1111/bju.16484","DOIUrl":null,"url":null,"abstract":"<div>\n \n <section>\n \n <h3> Background</h3>\n \n <p>Salvage radiotherapy (SRT) and androgen-deprivation therapy (ADT) are widely used in routine clinical practice to treat patients with prostate cancer who develop biochemical recurrence (BCR) after radical prostatectomy (RP). However, there is no standard-of-care consensus on optimal duration ADT. Investigators propose three distinct risk groups in patients with prostate cancer treated with SRT in order to better define the indications and duration of ADT combined with SRT.</p>\n </section>\n \n <section>\n \n <h3> Study design</h3>\n \n <p>The URONCOR 06-24 trial (ClinicalTrials.gov identifier NCT05781217) is a prospective, multicentre, randomised, open-label, phase III, clinical trial. The aim of the trial is to determine the impact of short-term (6 months) vs long-term (24 months) ADT in combination with SRT on distant metastasis-free survival (MFS) in patients with prostate cancer with BCR after RP (intermediate and high risk).</p>\n </section>\n \n <section>\n \n <h3> Endpoints</h3>\n \n <p>The primary endpoint is 5-year MFS rates in patients with prostate cancer treated with long- vs short-term ADT in combination with SRT. Secondary objectives are biochemical-relapse free interval, pelvic progression-free survival, time to start of systemic treatment, time to castration resistance, cancer-specific survival, overall survival, acute and late toxicity, and quality of life.</p>\n </section>\n \n <section>\n \n <h3> Methods and analysis</h3>\n \n <p>Total of 534 patients will be randomised 1:1 to ADT 6 months or ADT 24 months with a luteinizing hormone-releasing hormone analogue in combination with SRT, stratified by risk group and pathological lymph node status.</p>\n </section>\n \n <section>\n \n <h3> Ethics and dissemination</h3>\n \n <p>The study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.</p>\n </section>\n \n <section>\n \n <h3> Trial registration number</h3>\n \n <p>EudraCT number 2021-006975-41.</p>\n </section>\n </div>","PeriodicalId":8985,"journal":{"name":"BJU International","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomised trial of short- vs long-term androgen deprivation with salvage radiotherapy for biochemical failure following radical prostatectomy: URONCOR 06-24\",\"authors\":\"Carmen González-San Segundo, Fernando López Campos, Alfonso Gómez Iturriaga, Aurora Rodríguez, Jesús Olivera, Víctor Duque-Santana, Gemma Sancho, Iván Henríquez, Antonio José Conde, Jeannette Valero, Xavier Maldonado, Luis Glaria, Begoña Caballero, Noelia Sanmamed, Joel Mases, Anna María Boladeras-Inglada, Miguel Montijano, Marina Santos, Ana Álvarez, Juan I. Martínez, Felipe Couñago\",\"doi\":\"10.1111/bju.16484\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Salvage radiotherapy (SRT) and androgen-deprivation therapy (ADT) are widely used in routine clinical practice to treat patients with prostate cancer who develop biochemical recurrence (BCR) after radical prostatectomy (RP). However, there is no standard-of-care consensus on optimal duration ADT. Investigators propose three distinct risk groups in patients with prostate cancer treated with SRT in order to better define the indications and duration of ADT combined with SRT.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Study design</h3>\\n \\n <p>The URONCOR 06-24 trial (ClinicalTrials.gov identifier NCT05781217) is a prospective, multicentre, randomised, open-label, phase III, clinical trial. The aim of the trial is to determine the impact of short-term (6 months) vs long-term (24 months) ADT in combination with SRT on distant metastasis-free survival (MFS) in patients with prostate cancer with BCR after RP (intermediate and high risk).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Endpoints</h3>\\n \\n <p>The primary endpoint is 5-year MFS rates in patients with prostate cancer treated with long- vs short-term ADT in combination with SRT. Secondary objectives are biochemical-relapse free interval, pelvic progression-free survival, time to start of systemic treatment, time to castration resistance, cancer-specific survival, overall survival, acute and late toxicity, and quality of life.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods and analysis</h3>\\n \\n <p>Total of 534 patients will be randomised 1:1 to ADT 6 months or ADT 24 months with a luteinizing hormone-releasing hormone analogue in combination with SRT, stratified by risk group and pathological lymph node status.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Ethics and dissemination</h3>\\n \\n <p>The study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial registration number</h3>\\n \\n <p>EudraCT number 2021-006975-41.</p>\\n </section>\\n </div>\",\"PeriodicalId\":8985,\"journal\":{\"name\":\"BJU International\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-07-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BJU International\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/bju.16484\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BJU International","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/bju.16484","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
A randomised trial of short- vs long-term androgen deprivation with salvage radiotherapy for biochemical failure following radical prostatectomy: URONCOR 06-24
Background
Salvage radiotherapy (SRT) and androgen-deprivation therapy (ADT) are widely used in routine clinical practice to treat patients with prostate cancer who develop biochemical recurrence (BCR) after radical prostatectomy (RP). However, there is no standard-of-care consensus on optimal duration ADT. Investigators propose three distinct risk groups in patients with prostate cancer treated with SRT in order to better define the indications and duration of ADT combined with SRT.
Study design
The URONCOR 06-24 trial (ClinicalTrials.gov identifier NCT05781217) is a prospective, multicentre, randomised, open-label, phase III, clinical trial. The aim of the trial is to determine the impact of short-term (6 months) vs long-term (24 months) ADT in combination with SRT on distant metastasis-free survival (MFS) in patients with prostate cancer with BCR after RP (intermediate and high risk).
Endpoints
The primary endpoint is 5-year MFS rates in patients with prostate cancer treated with long- vs short-term ADT in combination with SRT. Secondary objectives are biochemical-relapse free interval, pelvic progression-free survival, time to start of systemic treatment, time to castration resistance, cancer-specific survival, overall survival, acute and late toxicity, and quality of life.
Methods and analysis
Total of 534 patients will be randomised 1:1 to ADT 6 months or ADT 24 months with a luteinizing hormone-releasing hormone analogue in combination with SRT, stratified by risk group and pathological lymph node status.
Ethics and dissemination
The study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.
期刊介绍：
BJUI is one of the most highly respected medical journals in the world, with a truly international range of published papers and appeal. Every issue gives invaluable practical information in the form of original articles, reviews, comments, surgical education articles, and translational science articles in the field of urology. BJUI employs topical sections, and is in full colour, making it easier to browse or search for something specific.
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