Juan Javier-DesLoges, Ana Flores Pimentel, Samuel Pena, Yasoda Satpathy, Yu-Wei Chen, Michael James Randall, Tyler Stewart, Christopher J Kane, Aditya Bagrodia, Clara Hwang, Lin Lu, Matthew Savage, Lisa Madlensky, Rana R McKay
{"title":"研究者发起的单臂临床试验,以改善高危前列腺癌患者的生殖系检测(IMPRINT)。","authors":"Juan Javier-DesLoges, Ana Flores Pimentel, Samuel Pena, Yasoda Satpathy, Yu-Wei Chen, Michael James Randall, Tyler Stewart, Christopher J Kane, Aditya Bagrodia, Clara Hwang, Lin Lu, Matthew Savage, Lisa Madlensky, Rana R McKay","doi":"10.1200/OP-25-00266","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Germline testing is recommended for patients with high-risk localized, locally advanced, and metastatic prostate cancer; however, implementation remains suboptimal. Novel strategies are needed to engage oncology clinicians and patients in germline testing.</p><p><strong>Methods: </strong>A single-arm investigator-initiated study, conducted from October 1, 2022, to December 31, 2023, used video education as pretest counseling for patients meeting National Cancer Comprehensive Network germline testing criteria. Patients attended a one-on-one in-person session with an educational video, followed by prevideo and postvideo questionnaires assessing knowledge and satisfaction. The primary end point was the proportion who underwent germline testing after intervention, compared with a contemporaneous standard-of-care (SOC) group. Secondary end points included changes in knowledge and perceptions.</p><p><strong>Results: </strong>All 50 enrolled patients completed the intervention. Patients were predominantly White (78.0%), non-Hispanic (92.0%), English-speaking (98.0%), and college-educated (70%). Most had high-risk localized (46.0%) or metastatic hormone-sensitive prostate cancer (26.0%). Germline testing uptake was significantly higher in the intervention group (82.0%, 41/50) compared with the SOC group (37.94%, 107/282, <i>P</i> < .001). In the intervention group, urologists ordered 22.5% of tests and medical oncologists ordered 77.5%. Pathogenic/likely pathogenic alterations were identified in 10.0% of patients. Most participants (64%) indicated that the most important factor in their decision was whether results could guide treatment. Those who declined testing cited lack of clinical value. Most scored high on the prevideo genetic knowledge test (mean 9.1/11.0) with no statistical difference postvideo (<i>P</i> = .88). Most found the video satisfactory and useful (94%).</p><p><strong>Conclusion: </strong>Germline testing uptake was high after video education. Most patients had high baseline genetic knowledge but were more likely to pursue testing after intervention if it influenced their treatment. Virtual educational aids should be integrated into clinical practice to increase testing rates.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500266"},"PeriodicalIF":4.6000,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Single-Arm Investigator-Initiated Clinical Trial to Improve Germline Testing in At-Risk Patients With Prostate Cancer (IMPRINT).\",\"authors\":\"Juan Javier-DesLoges, Ana Flores Pimentel, Samuel Pena, Yasoda Satpathy, Yu-Wei Chen, Michael James Randall, Tyler Stewart, Christopher J Kane, Aditya Bagrodia, Clara Hwang, Lin Lu, Matthew Savage, Lisa Madlensky, Rana R McKay\",\"doi\":\"10.1200/OP-25-00266\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Germline testing is recommended for patients with high-risk localized, locally advanced, and metastatic prostate cancer; however, implementation remains suboptimal. Novel strategies are needed to engage oncology clinicians and patients in germline testing.</p><p><strong>Methods: </strong>A single-arm investigator-initiated study, conducted from October 1, 2022, to December 31, 2023, used video education as pretest counseling for patients meeting National Cancer Comprehensive Network germline testing criteria. Patients attended a one-on-one in-person session with an educational video, followed by prevideo and postvideo questionnaires assessing knowledge and satisfaction. The primary end point was the proportion who underwent germline testing after intervention, compared with a contemporaneous standard-of-care (SOC) group. Secondary end points included changes in knowledge and perceptions.</p><p><strong>Results: </strong>All 50 enrolled patients completed the intervention. Patients were predominantly White (78.0%), non-Hispanic (92.0%), English-speaking (98.0%), and college-educated (70%). Most had high-risk localized (46.0%) or metastatic hormone-sensitive prostate cancer (26.0%). Germline testing uptake was significantly higher in the intervention group (82.0%, 41/50) compared with the SOC group (37.94%, 107/282, <i>P</i> < .001). In the intervention group, urologists ordered 22.5% of tests and medical oncologists ordered 77.5%. Pathogenic/likely pathogenic alterations were identified in 10.0% of patients. Most participants (64%) indicated that the most important factor in their decision was whether results could guide treatment. Those who declined testing cited lack of clinical value. Most scored high on the prevideo genetic knowledge test (mean 9.1/11.0) with no statistical difference postvideo (<i>P</i> = .88). Most found the video satisfactory and useful (94%).</p><p><strong>Conclusion: </strong>Germline testing uptake was high after video education. Most patients had high baseline genetic knowledge but were more likely to pursue testing after intervention if it influenced their treatment. Virtual educational aids should be integrated into clinical practice to increase testing rates.</p>\",\"PeriodicalId\":14612,\"journal\":{\"name\":\"JCO oncology practice\",\"volume\":\" \",\"pages\":\"OP2500266\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2025-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JCO oncology practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/OP-25-00266\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JCO oncology practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/OP-25-00266","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Single-Arm Investigator-Initiated Clinical Trial to Improve Germline Testing in At-Risk Patients With Prostate Cancer (IMPRINT).
Purpose: Germline testing is recommended for patients with high-risk localized, locally advanced, and metastatic prostate cancer; however, implementation remains suboptimal. Novel strategies are needed to engage oncology clinicians and patients in germline testing.
Methods: A single-arm investigator-initiated study, conducted from October 1, 2022, to December 31, 2023, used video education as pretest counseling for patients meeting National Cancer Comprehensive Network germline testing criteria. Patients attended a one-on-one in-person session with an educational video, followed by prevideo and postvideo questionnaires assessing knowledge and satisfaction. The primary end point was the proportion who underwent germline testing after intervention, compared with a contemporaneous standard-of-care (SOC) group. Secondary end points included changes in knowledge and perceptions.
Results: All 50 enrolled patients completed the intervention. Patients were predominantly White (78.0%), non-Hispanic (92.0%), English-speaking (98.0%), and college-educated (70%). Most had high-risk localized (46.0%) or metastatic hormone-sensitive prostate cancer (26.0%). Germline testing uptake was significantly higher in the intervention group (82.0%, 41/50) compared with the SOC group (37.94%, 107/282, P < .001). In the intervention group, urologists ordered 22.5% of tests and medical oncologists ordered 77.5%. Pathogenic/likely pathogenic alterations were identified in 10.0% of patients. Most participants (64%) indicated that the most important factor in their decision was whether results could guide treatment. Those who declined testing cited lack of clinical value. Most scored high on the prevideo genetic knowledge test (mean 9.1/11.0) with no statistical difference postvideo (P = .88). Most found the video satisfactory and useful (94%).
Conclusion: Germline testing uptake was high after video education. Most patients had high baseline genetic knowledge but were more likely to pursue testing after intervention if it influenced their treatment. Virtual educational aids should be integrated into clinical practice to increase testing rates.