{"title":"当代前列腺癌放射治疗试验可能低估了生化复发的风险。","authors":"Michael West, Jose M Flores, John P Mulhall","doi":"10.1093/jsxmed/qdae191","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Radiotherapy is often given with androgen deprivation therapy for prostate cancer which causes a reduction in testosterone levels, which when below castrate levels, can cause the prostate specific antigen (PSA) levels to be artificially low.</p><p><strong>Aim: </strong>To determine if high-level radiotherapy clinical trials are underestimating biochemical recurrence (BCR) rates due to inadequate measurement of testosterone levels.</p><p><strong>Methods: </strong>The study plans for clinical trials performed by the Radiation Therapy Oncology Group (RTOG [now NRG]) on clinicaltrials.gov were reviewed for details on testosterone measurement in trials from 1994 to 2023, namely if the testosterone levels were indexed to PSA levels.</p><p><strong>Outcomes: </strong>PSA being indexed to testosterone levels and other metrics of testosterone measurement, including time of day of measurement, assay used, and mean testosterone measurement.</p><p><strong>Results: </strong>Five of 21 (24%) trials stipulated that testosterone levels should be indexed to PSA levels. Eleven of 21 (52%) trials made no mention of testosterone. No trial reported testosterone assay or time of day of measurement. Thirteen of 21 (62%) trials did not require regular follow-up testosterone measurements.</p><p><strong>Clinical implications: </strong>The number of clinical trials indexing or regularly measuring testosterone was surprisingly low, which could cause an underestimation of BCR rates.</p><p><strong>Strengths and limitations: </strong>Strengths include being the first study, to our knowledge, to analyze the details of testosterone measurement in high-level radiotherapy trials. Limitations include only analyzing RTOG/NRG trials, analyzing unpublished data, and using clinicaltrials.gov rather than official trial protocols to determine details of testosterone measurement.</p><p><strong>Conclusion: </strong>Indexing of testosterone levels to PSA levels in high-level radiotherapy trials using androgen deprivation therapy was uncommon, possibly rendering data on BCR unreliable, potentially underestimating BCR rates.</p>","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Contemporary prostate cancer radiation therapy trials may underestimate the risk of biochemical recurrence.\",\"authors\":\"Michael West, Jose M Flores, John P Mulhall\",\"doi\":\"10.1093/jsxmed/qdae191\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Radiotherapy is often given with androgen deprivation therapy for prostate cancer which causes a reduction in testosterone levels, which when below castrate levels, can cause the prostate specific antigen (PSA) levels to be artificially low.</p><p><strong>Aim: </strong>To determine if high-level radiotherapy clinical trials are underestimating biochemical recurrence (BCR) rates due to inadequate measurement of testosterone levels.</p><p><strong>Methods: </strong>The study plans for clinical trials performed by the Radiation Therapy Oncology Group (RTOG [now NRG]) on clinicaltrials.gov were reviewed for details on testosterone measurement in trials from 1994 to 2023, namely if the testosterone levels were indexed to PSA levels.</p><p><strong>Outcomes: </strong>PSA being indexed to testosterone levels and other metrics of testosterone measurement, including time of day of measurement, assay used, and mean testosterone measurement.</p><p><strong>Results: </strong>Five of 21 (24%) trials stipulated that testosterone levels should be indexed to PSA levels. Eleven of 21 (52%) trials made no mention of testosterone. No trial reported testosterone assay or time of day of measurement. Thirteen of 21 (62%) trials did not require regular follow-up testosterone measurements.</p><p><strong>Clinical implications: </strong>The number of clinical trials indexing or regularly measuring testosterone was surprisingly low, which could cause an underestimation of BCR rates.</p><p><strong>Strengths and limitations: </strong>Strengths include being the first study, to our knowledge, to analyze the details of testosterone measurement in high-level radiotherapy trials. Limitations include only analyzing RTOG/NRG trials, analyzing unpublished data, and using clinicaltrials.gov rather than official trial protocols to determine details of testosterone measurement.</p><p><strong>Conclusion: </strong>Indexing of testosterone levels to PSA levels in high-level radiotherapy trials using androgen deprivation therapy was uncommon, possibly rendering data on BCR unreliable, potentially underestimating BCR rates.</p>\",\"PeriodicalId\":51100,\"journal\":{\"name\":\"Journal of Sexual Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-12-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Sexual Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/jsxmed/qdae191\",\"RegionNum\":3,\"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":"Journal of Sexual Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jsxmed/qdae191","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Contemporary prostate cancer radiation therapy trials may underestimate the risk of biochemical recurrence.
Background: Radiotherapy is often given with androgen deprivation therapy for prostate cancer which causes a reduction in testosterone levels, which when below castrate levels, can cause the prostate specific antigen (PSA) levels to be artificially low.
Aim: To determine if high-level radiotherapy clinical trials are underestimating biochemical recurrence (BCR) rates due to inadequate measurement of testosterone levels.
Methods: The study plans for clinical trials performed by the Radiation Therapy Oncology Group (RTOG [now NRG]) on clinicaltrials.gov were reviewed for details on testosterone measurement in trials from 1994 to 2023, namely if the testosterone levels were indexed to PSA levels.
Outcomes: PSA being indexed to testosterone levels and other metrics of testosterone measurement, including time of day of measurement, assay used, and mean testosterone measurement.
Results: Five of 21 (24%) trials stipulated that testosterone levels should be indexed to PSA levels. Eleven of 21 (52%) trials made no mention of testosterone. No trial reported testosterone assay or time of day of measurement. Thirteen of 21 (62%) trials did not require regular follow-up testosterone measurements.
Clinical implications: The number of clinical trials indexing or regularly measuring testosterone was surprisingly low, which could cause an underestimation of BCR rates.
Strengths and limitations: Strengths include being the first study, to our knowledge, to analyze the details of testosterone measurement in high-level radiotherapy trials. Limitations include only analyzing RTOG/NRG trials, analyzing unpublished data, and using clinicaltrials.gov rather than official trial protocols to determine details of testosterone measurement.
Conclusion: Indexing of testosterone levels to PSA levels in high-level radiotherapy trials using androgen deprivation therapy was uncommon, possibly rendering data on BCR unreliable, potentially underestimating BCR rates.
期刊介绍：
The Journal of Sexual Medicine publishes multidisciplinary basic science and clinical research to define and understand the scientific basis of male, female, and couples sexual function and dysfunction. As an official journal of the International Society for Sexual Medicine and the International Society for the Study of Women''s Sexual Health, it provides healthcare professionals in sexual medicine with essential educational content and promotes the exchange of scientific information generated from experimental and clinical research.
The Journal of Sexual Medicine includes basic science and clinical research studies in the psychologic and biologic aspects of male, female, and couples sexual function and dysfunction, and highlights new observations and research, results with innovative treatments and all other topics relevant to clinical sexual medicine.
The objective of The Journal of Sexual Medicine is to serve as an interdisciplinary forum to integrate the exchange among disciplines concerned with the whole field of human sexuality. The journal accomplishes this objective by publishing original articles, as well as other scientific and educational documents that support the mission of the International Society for Sexual Medicine.
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