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James W Morris - One of the best experts on this subject based on the ideXlab platform.
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ascende rt an analysis of treatment related morbidity for a randomized trial comparing a low dose rate Brachytherapy boost with a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: Sree Rodda, James W Morris, Mira Keyes, Scott Tyldesley, Ross Halperin, Howard PaiAbstract:Purpose To report the genitourinary (GU) and gastrointestinal (GI) morbidity and erectile dysfunction in a randomized trial comparing 2 methods of dose escalation for high- and intermediate-risk prostate cancer. Methods and Materials ASCENDE-RT (Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy) enrolled 398 men, median age 68 years, who were then randomized to either a standard arm that included 12 months of androgen deprivation therapy and pelvic irradiation to 46 Gy followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. At clinic visits, investigators recorded GU and GI morbidity and information on urinary continence, catheter use, and erectile function. Exclusion of 15 who received nonprotocol treatment and correction of 14 crossover events left 195 men who actually received a DE-EBRT boost and 188, an LDR-PB boost. Median follow-up was 6.5 years. Results The LDR-PB boost increased the risk of needing temporary catheterization and/or requiring incontinence pads. At 5 years the cumulative incidence of grade 3 GU events was 18.4% for LDR-PB, versus 5.2% for DE-EBRT ( P P =.058). The 5-year cumulative incidence of grade 3 GI events was 8.1% for LDR-PB, versus 3.2% for DE-EBRT ( P =.124). The 5-year prevalence of grade 3 GI toxicity was lower than the cumulative incidence for both arms (1.0% vs 2.2%, respectively). Among men reporting adequate baseline erections, 45% of LDR-PB patients reported similar erectile function at 5 years, versus 37% after DE-EBRT ( P =.30). Conclusions The incidence of acute and late GU morbidity was higher after LDR-PB boost, and there was a nonsignificant trend for worse GI morbidity. No differences in the frequency of erectile dysfunction were observed.
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androgen suppression combined with elective nodal and dose escalated radiation therapy the ascende rt trial an analysis of survival endpoints for a randomized trial comparing a low dose rate Brachytherapy boost to a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: James W Morris, Howard Pai, Scott Tyldesley, Ross Halperin, Sree Rodda, Michael MckenzieAbstract:Purpose To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer. Methods and Materials ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years. Results In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P =.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P P =.004) and biochemical failure (MVA HR 6.30; P P =.62). Conclusions Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years.
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ascende rt a multicenter randomized trial of dose escalated external beam radiation therapy ebrt b versus low dose rate Brachytherapy ldr b for men with unfavorable risk localized prostate cancer
Journal of Clinical Oncology, 2015Co-Authors: James W Morris, Michael Mckenzie, Howard Pai, Scott Tyldesley, Ross Halperin, Graeme Duncan, Gerard Morton, Nevin Murray, Jeremy HammAbstract:3 Background: This trial compared the efficacy of DE-EBRT and LDR-B for National Comprehensive Cancer Network (NCCN) high and intermediate-risk disease. Methods: A planned sample size of 400 patients were randomized to one of two treatment arms and stratified by risk group. Both arms received 12 months of androgen deprivation therapy (ADT) with luteinizing hormone releasing hormone (LHRH) agonist plus a non-steroidal anti-androgen for at least 1 month. After 8 months of neo-adjuvant ADT, both arms received whole pelvis EBRT (46Gy/23#). Patients assigned to DE-EBRT (standard arm) then received a conformal EBRT boost (32Gy/16#). Patients assigned to LDR-B (experimental arm) received an Iodine-125 LDR boost prescribed to a minimum peripheral dose of 115Gy. The primary endpoint was relapse free survival (RFS) defined by biochemical criteria using the nadir+2 ng/mL threshold. Time zero was the date of the first LHRH injection. Results: Between Dec 2002 and Sep 2011, 276 high-risk and 122 intermediate-risk pati...
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population based 10 year oncologic outcomes after low dose rate Brachytherapy for low risk and intermediate risk prostate cancer
Cancer, 2013Co-Authors: James W Morris, Mira Keyes, I Spadinger, Winkle Kwan, Mitchell Liu, Michael Mckenzie, Howard Pai, Tom Pickles, Scott TyldesleyAbstract:BACKGROUND. The objective of this study was to report the rates of disease-free survival (DFS), cause-specific survival (CSS), and overall survival after Low-Dose-Rate (LDR) prostate Brachytherapy (PB). METHODS. Data from 1006 consecutive patients with prostate cancer who received LDR-PB and underwent implantation on or before October 23, 2003 were extracted from a prospective database on November 11, 2011. The selected patients had low-risk (58%) or intermediate-risk (42%) disease according to National Comprehensive Cancer Network criteria. The Phoenix threshold was used to define biochemical relapse. Sixty-five percent of patients received 3 months of neoadjuvant androgen-deprivation therapy (ADT) and 3 months of concomitant ADT. Univariate and multivariate analyses are reported in relation to patient, tumor, and treatment variables. RESULTS. The median follow-up was 7.5 years. By using Fine and Gray competing risks analysis, the 5-year and 10-year actuarial DFS rates were 96.7% (95% confidence interval, 95.2%-97.7%) and 94.1% (95% confidence interval, 92%-95.6%), respectively. When applied to the whole cohort, none of the usual prognostic variables, including dose metrics, were correlated with DFS. However, in both univariate and multivariate models, increasing dose was the only covariate that correlated with improved DFS for the subset of men (N = 348) who did not receive ADT (P = .043). The actuarial 10-year CSS rate was 99.1% (95% confidence interval, 97.3%-99.7%). The overall survival rate was 93.8% at 5 years (95% confidence interval, 92%-95.1%) and 83.5% at 10 years (95% confidence interval, 79.8%-86.6%). Only age at implantation (P = .0001) was correlated with overall survival in multivariate analysis. CONCLUSIONS. In a consecutive cohort of 1006 men with National Comprehensive Cancer Network low-risk and intermediate-risk prostate cancer, the actuarial rate of recurrent disease after LDR-PB was approximately 3% at 5 years and 6% at 10 years. Cancer 2013. © 2012 American Cancer Society.
Howard Pai - One of the best experts on this subject based on the ideXlab platform.
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ascende rt an analysis of treatment related morbidity for a randomized trial comparing a low dose rate Brachytherapy boost with a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: Sree Rodda, James W Morris, Mira Keyes, Scott Tyldesley, Ross Halperin, Howard PaiAbstract:Purpose To report the genitourinary (GU) and gastrointestinal (GI) morbidity and erectile dysfunction in a randomized trial comparing 2 methods of dose escalation for high- and intermediate-risk prostate cancer. Methods and Materials ASCENDE-RT (Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy) enrolled 398 men, median age 68 years, who were then randomized to either a standard arm that included 12 months of androgen deprivation therapy and pelvic irradiation to 46 Gy followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. At clinic visits, investigators recorded GU and GI morbidity and information on urinary continence, catheter use, and erectile function. Exclusion of 15 who received nonprotocol treatment and correction of 14 crossover events left 195 men who actually received a DE-EBRT boost and 188, an LDR-PB boost. Median follow-up was 6.5 years. Results The LDR-PB boost increased the risk of needing temporary catheterization and/or requiring incontinence pads. At 5 years the cumulative incidence of grade 3 GU events was 18.4% for LDR-PB, versus 5.2% for DE-EBRT ( P P =.058). The 5-year cumulative incidence of grade 3 GI events was 8.1% for LDR-PB, versus 3.2% for DE-EBRT ( P =.124). The 5-year prevalence of grade 3 GI toxicity was lower than the cumulative incidence for both arms (1.0% vs 2.2%, respectively). Among men reporting adequate baseline erections, 45% of LDR-PB patients reported similar erectile function at 5 years, versus 37% after DE-EBRT ( P =.30). Conclusions The incidence of acute and late GU morbidity was higher after LDR-PB boost, and there was a nonsignificant trend for worse GI morbidity. No differences in the frequency of erectile dysfunction were observed.
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androgen suppression combined with elective nodal and dose escalated radiation therapy the ascende rt trial an analysis of survival endpoints for a randomized trial comparing a low dose rate Brachytherapy boost to a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: James W Morris, Howard Pai, Scott Tyldesley, Ross Halperin, Sree Rodda, Michael MckenzieAbstract:Purpose To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer. Methods and Materials ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years. Results In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P =.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P P =.004) and biochemical failure (MVA HR 6.30; P P =.62). Conclusions Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years.
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ascende rt a multicenter randomized trial of dose escalated external beam radiation therapy ebrt b versus low dose rate Brachytherapy ldr b for men with unfavorable risk localized prostate cancer
Journal of Clinical Oncology, 2015Co-Authors: James W Morris, Michael Mckenzie, Howard Pai, Scott Tyldesley, Ross Halperin, Graeme Duncan, Gerard Morton, Nevin Murray, Jeremy HammAbstract:3 Background: This trial compared the efficacy of DE-EBRT and LDR-B for National Comprehensive Cancer Network (NCCN) high and intermediate-risk disease. Methods: A planned sample size of 400 patients were randomized to one of two treatment arms and stratified by risk group. Both arms received 12 months of androgen deprivation therapy (ADT) with luteinizing hormone releasing hormone (LHRH) agonist plus a non-steroidal anti-androgen for at least 1 month. After 8 months of neo-adjuvant ADT, both arms received whole pelvis EBRT (46Gy/23#). Patients assigned to DE-EBRT (standard arm) then received a conformal EBRT boost (32Gy/16#). Patients assigned to LDR-B (experimental arm) received an Iodine-125 LDR boost prescribed to a minimum peripheral dose of 115Gy. The primary endpoint was relapse free survival (RFS) defined by biochemical criteria using the nadir+2 ng/mL threshold. Time zero was the date of the first LHRH injection. Results: Between Dec 2002 and Sep 2011, 276 high-risk and 122 intermediate-risk pati...
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population based 10 year oncologic outcomes after low dose rate Brachytherapy for low risk and intermediate risk prostate cancer
Cancer, 2013Co-Authors: James W Morris, Mira Keyes, I Spadinger, Winkle Kwan, Mitchell Liu, Michael Mckenzie, Howard Pai, Tom Pickles, Scott TyldesleyAbstract:BACKGROUND. The objective of this study was to report the rates of disease-free survival (DFS), cause-specific survival (CSS), and overall survival after Low-Dose-Rate (LDR) prostate Brachytherapy (PB). METHODS. Data from 1006 consecutive patients with prostate cancer who received LDR-PB and underwent implantation on or before October 23, 2003 were extracted from a prospective database on November 11, 2011. The selected patients had low-risk (58%) or intermediate-risk (42%) disease according to National Comprehensive Cancer Network criteria. The Phoenix threshold was used to define biochemical relapse. Sixty-five percent of patients received 3 months of neoadjuvant androgen-deprivation therapy (ADT) and 3 months of concomitant ADT. Univariate and multivariate analyses are reported in relation to patient, tumor, and treatment variables. RESULTS. The median follow-up was 7.5 years. By using Fine and Gray competing risks analysis, the 5-year and 10-year actuarial DFS rates were 96.7% (95% confidence interval, 95.2%-97.7%) and 94.1% (95% confidence interval, 92%-95.6%), respectively. When applied to the whole cohort, none of the usual prognostic variables, including dose metrics, were correlated with DFS. However, in both univariate and multivariate models, increasing dose was the only covariate that correlated with improved DFS for the subset of men (N = 348) who did not receive ADT (P = .043). The actuarial 10-year CSS rate was 99.1% (95% confidence interval, 97.3%-99.7%). The overall survival rate was 93.8% at 5 years (95% confidence interval, 92%-95.1%) and 83.5% at 10 years (95% confidence interval, 79.8%-86.6%). Only age at implantation (P = .0001) was correlated with overall survival in multivariate analysis. CONCLUSIONS. In a consecutive cohort of 1006 men with National Comprehensive Cancer Network low-risk and intermediate-risk prostate cancer, the actuarial rate of recurrent disease after LDR-PB was approximately 3% at 5 years and 6% at 10 years. Cancer 2013. © 2012 American Cancer Society.
Scott Tyldesley - One of the best experts on this subject based on the ideXlab platform.
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ascende rt an analysis of treatment related morbidity for a randomized trial comparing a low dose rate Brachytherapy boost with a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: Sree Rodda, James W Morris, Mira Keyes, Scott Tyldesley, Ross Halperin, Howard PaiAbstract:Purpose To report the genitourinary (GU) and gastrointestinal (GI) morbidity and erectile dysfunction in a randomized trial comparing 2 methods of dose escalation for high- and intermediate-risk prostate cancer. Methods and Materials ASCENDE-RT (Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy) enrolled 398 men, median age 68 years, who were then randomized to either a standard arm that included 12 months of androgen deprivation therapy and pelvic irradiation to 46 Gy followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. At clinic visits, investigators recorded GU and GI morbidity and information on urinary continence, catheter use, and erectile function. Exclusion of 15 who received nonprotocol treatment and correction of 14 crossover events left 195 men who actually received a DE-EBRT boost and 188, an LDR-PB boost. Median follow-up was 6.5 years. Results The LDR-PB boost increased the risk of needing temporary catheterization and/or requiring incontinence pads. At 5 years the cumulative incidence of grade 3 GU events was 18.4% for LDR-PB, versus 5.2% for DE-EBRT ( P P =.058). The 5-year cumulative incidence of grade 3 GI events was 8.1% for LDR-PB, versus 3.2% for DE-EBRT ( P =.124). The 5-year prevalence of grade 3 GI toxicity was lower than the cumulative incidence for both arms (1.0% vs 2.2%, respectively). Among men reporting adequate baseline erections, 45% of LDR-PB patients reported similar erectile function at 5 years, versus 37% after DE-EBRT ( P =.30). Conclusions The incidence of acute and late GU morbidity was higher after LDR-PB boost, and there was a nonsignificant trend for worse GI morbidity. No differences in the frequency of erectile dysfunction were observed.
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androgen suppression combined with elective nodal and dose escalated radiation therapy the ascende rt trial an analysis of survival endpoints for a randomized trial comparing a low dose rate Brachytherapy boost to a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: James W Morris, Howard Pai, Scott Tyldesley, Ross Halperin, Sree Rodda, Michael MckenzieAbstract:Purpose To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer. Methods and Materials ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years. Results In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P =.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P P =.004) and biochemical failure (MVA HR 6.30; P P =.62). Conclusions Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years.
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ascende rt a multicenter randomized trial of dose escalated external beam radiation therapy ebrt b versus low dose rate Brachytherapy ldr b for men with unfavorable risk localized prostate cancer
Journal of Clinical Oncology, 2015Co-Authors: James W Morris, Michael Mckenzie, Howard Pai, Scott Tyldesley, Ross Halperin, Graeme Duncan, Gerard Morton, Nevin Murray, Jeremy HammAbstract:3 Background: This trial compared the efficacy of DE-EBRT and LDR-B for National Comprehensive Cancer Network (NCCN) high and intermediate-risk disease. Methods: A planned sample size of 400 patients were randomized to one of two treatment arms and stratified by risk group. Both arms received 12 months of androgen deprivation therapy (ADT) with luteinizing hormone releasing hormone (LHRH) agonist plus a non-steroidal anti-androgen for at least 1 month. After 8 months of neo-adjuvant ADT, both arms received whole pelvis EBRT (46Gy/23#). Patients assigned to DE-EBRT (standard arm) then received a conformal EBRT boost (32Gy/16#). Patients assigned to LDR-B (experimental arm) received an Iodine-125 LDR boost prescribed to a minimum peripheral dose of 115Gy. The primary endpoint was relapse free survival (RFS) defined by biochemical criteria using the nadir+2 ng/mL threshold. Time zero was the date of the first LHRH injection. Results: Between Dec 2002 and Sep 2011, 276 high-risk and 122 intermediate-risk pati...
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population based 10 year oncologic outcomes after low dose rate Brachytherapy for low risk and intermediate risk prostate cancer
Cancer, 2013Co-Authors: James W Morris, Mira Keyes, I Spadinger, Winkle Kwan, Mitchell Liu, Michael Mckenzie, Howard Pai, Tom Pickles, Scott TyldesleyAbstract:BACKGROUND. The objective of this study was to report the rates of disease-free survival (DFS), cause-specific survival (CSS), and overall survival after Low-Dose-Rate (LDR) prostate Brachytherapy (PB). METHODS. Data from 1006 consecutive patients with prostate cancer who received LDR-PB and underwent implantation on or before October 23, 2003 were extracted from a prospective database on November 11, 2011. The selected patients had low-risk (58%) or intermediate-risk (42%) disease according to National Comprehensive Cancer Network criteria. The Phoenix threshold was used to define biochemical relapse. Sixty-five percent of patients received 3 months of neoadjuvant androgen-deprivation therapy (ADT) and 3 months of concomitant ADT. Univariate and multivariate analyses are reported in relation to patient, tumor, and treatment variables. RESULTS. The median follow-up was 7.5 years. By using Fine and Gray competing risks analysis, the 5-year and 10-year actuarial DFS rates were 96.7% (95% confidence interval, 95.2%-97.7%) and 94.1% (95% confidence interval, 92%-95.6%), respectively. When applied to the whole cohort, none of the usual prognostic variables, including dose metrics, were correlated with DFS. However, in both univariate and multivariate models, increasing dose was the only covariate that correlated with improved DFS for the subset of men (N = 348) who did not receive ADT (P = .043). The actuarial 10-year CSS rate was 99.1% (95% confidence interval, 97.3%-99.7%). The overall survival rate was 93.8% at 5 years (95% confidence interval, 92%-95.1%) and 83.5% at 10 years (95% confidence interval, 79.8%-86.6%). Only age at implantation (P = .0001) was correlated with overall survival in multivariate analysis. CONCLUSIONS. In a consecutive cohort of 1006 men with National Comprehensive Cancer Network low-risk and intermediate-risk prostate cancer, the actuarial rate of recurrent disease after LDR-PB was approximately 3% at 5 years and 6% at 10 years. Cancer 2013. © 2012 American Cancer Society.
Ross Halperin - One of the best experts on this subject based on the ideXlab platform.
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androgen suppression combined with elective nodal and dose escalated radiation therapy the ascende rt trial an analysis of survival endpoints for a randomized trial comparing a low dose rate Brachytherapy boost to a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: James W Morris, Howard Pai, Scott Tyldesley, Ross Halperin, Sree Rodda, Michael MckenzieAbstract:Purpose To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer. Methods and Materials ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years. Results In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P =.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P P =.004) and biochemical failure (MVA HR 6.30; P P =.62). Conclusions Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years.
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ascende rt an analysis of treatment related morbidity for a randomized trial comparing a low dose rate Brachytherapy boost with a dose escalated external beam boost for high and intermediate risk prostate cancer
International Journal of Radiation Oncology Biology Physics, 2017Co-Authors: Sree Rodda, James W Morris, Mira Keyes, Scott Tyldesley, Ross Halperin, Howard PaiAbstract:Purpose To report the genitourinary (GU) and gastrointestinal (GI) morbidity and erectile dysfunction in a randomized trial comparing 2 methods of dose escalation for high- and intermediate-risk prostate cancer. Methods and Materials ASCENDE-RT (Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy) enrolled 398 men, median age 68 years, who were then randomized to either a standard arm that included 12 months of androgen deprivation therapy and pelvic irradiation to 46 Gy followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a Low-Dose-Rate prostate Brachytherapy (LDR-PB) boost. At clinic visits, investigators recorded GU and GI morbidity and information on urinary continence, catheter use, and erectile function. Exclusion of 15 who received nonprotocol treatment and correction of 14 crossover events left 195 men who actually received a DE-EBRT boost and 188, an LDR-PB boost. Median follow-up was 6.5 years. Results The LDR-PB boost increased the risk of needing temporary catheterization and/or requiring incontinence pads. At 5 years the cumulative incidence of grade 3 GU events was 18.4% for LDR-PB, versus 5.2% for DE-EBRT ( P P =.058). The 5-year cumulative incidence of grade 3 GI events was 8.1% for LDR-PB, versus 3.2% for DE-EBRT ( P =.124). The 5-year prevalence of grade 3 GI toxicity was lower than the cumulative incidence for both arms (1.0% vs 2.2%, respectively). Among men reporting adequate baseline erections, 45% of LDR-PB patients reported similar erectile function at 5 years, versus 37% after DE-EBRT ( P =.30). Conclusions The incidence of acute and late GU morbidity was higher after LDR-PB boost, and there was a nonsignificant trend for worse GI morbidity. No differences in the frequency of erectile dysfunction were observed.
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ascende rt a multicenter randomized trial of dose escalated external beam radiation therapy ebrt b versus low dose rate Brachytherapy ldr b for men with unfavorable risk localized prostate cancer
Journal of Clinical Oncology, 2015Co-Authors: James W Morris, Michael Mckenzie, Howard Pai, Scott Tyldesley, Ross Halperin, Graeme Duncan, Gerard Morton, Nevin Murray, Jeremy HammAbstract:3 Background: This trial compared the efficacy of DE-EBRT and LDR-B for National Comprehensive Cancer Network (NCCN) high and intermediate-risk disease. Methods: A planned sample size of 400 patients were randomized to one of two treatment arms and stratified by risk group. Both arms received 12 months of androgen deprivation therapy (ADT) with luteinizing hormone releasing hormone (LHRH) agonist plus a non-steroidal anti-androgen for at least 1 month. After 8 months of neo-adjuvant ADT, both arms received whole pelvis EBRT (46Gy/23#). Patients assigned to DE-EBRT (standard arm) then received a conformal EBRT boost (32Gy/16#). Patients assigned to LDR-B (experimental arm) received an Iodine-125 LDR boost prescribed to a minimum peripheral dose of 115Gy. The primary endpoint was relapse free survival (RFS) defined by biochemical criteria using the nadir+2 ng/mL threshold. Time zero was the date of the first LHRH injection. Results: Between Dec 2002 and Sep 2011, 276 high-risk and 122 intermediate-risk pati...
Kiyohide Fujimoto - One of the best experts on this subject based on the ideXlab platform.
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analysis of quality of life after randomized controlled trial of alpha 1 adrenoceptor antagonist alone and in combination with cyclooxygenase 2 inhibitor in patients who underwent low dose rate Brachytherapy for prostate cancer
Journal of Contemporary Brachytherapy, 2019Co-Authors: Yasushi Nakai, Nobumichi Tanaka, Kazumasa Torimoto, Isao Asakawa, Makito Miyake, Satoshi Anai, Tomomi Fujii, Masatoshi Hasegawa, Kiyohide FujimotoAbstract:Purpose The goal of this study was to evaluate the effect of cyclooxygenase-2 (COX-2) inhibitors on quality of life (QoL) of patients undergoing Low-Dose-Rate (LDR) Brachytherapy. Material and methods A total of 310 patients with prostate cancer who had undergone LDR Brachytherapy were enrolled. The patients were randomized (1 : 1) to the monotherapy group (tamsulosin alone: 0.2 mg/day, n = 156) and the combination group (tamsulosin: 0.2 mg/day plus celecoxib: 200 mg/day, n = 154) without placebo. Using the expanded prostate cancer index composite (EPIC) and medical outcomes study 8-item short form health survey (SF-8) questionnaire, QoL was evaluated at baseline and at 1, 3, 6, and 12 months after seed implantation. Results The mean changes in scores from baseline to 1 and 3 months after seed implantation for the urinary (1M: -10.5, 3M: -10.9) and bowel (1M: -2.4, 3M: -4.2) domains of EPIC in the combination group were not significantly different from those (urinary 1M: -11.0, 3M: -11.4, bowel 1M: -2.3, 3M: -4.6) in the monotherapy group. The mean changes in scores from baseline to 1 and 3 months after seed implantation for the physical component summary (1M: 0.009, 3M: -0.32) and mental component summary (1M: 0.41, 3M: 0.36) of SF-8 in the combination group were not significantly different from those (physical component 1M: -0.89, 3M: -0.22, mental component 1M: 1.3, 3M: 1.1) in the monotherapy group. Conclusions Combination treatment with celecoxib and tamsulosin during the peri-operative period is not warranted for improving QoL in patients undergoing LDR Brachytherapy.
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comparison of chronological changes in urinary function in patients who underwent low dose rate Brachytherapy for prostate cancer a randomized controlled trial of alpha 1 adrenoceptor antagonist alone versus combination with cyclooxygenase 2 inhibito
Brachytherapy, 2018Co-Authors: Nobumichi Tanaka, Kazumasa Torimoto, Isao Asakawa, Makito Miyake, Satoshi Anai, Yasushi Nakai, Tomomi Fujii, Masatoshi Hasegawa, Kiyohide FujimotoAbstract:Abstract Purpose To evaluate the add-on efficacy of a cyclooxygenase (COX)-2 inhibitor on the chronological changes in urinary function in patients who underwent Low-Dose-Rate prostate Brachytherapy. Methods and Materials A total of 310 patients with prostate cancer who underwent Low-Dose-Rate-Brachytherapy were enrolled. Patients were randomized and allocated to the monotherapy group (tamsulosin alone: 0.2 mg/d) and the combination group (tamsulosin 0.2 mg/d plus celecoxib: 200 mg/d). We compared the chronological change in the international prostate symptom score (IPSS), the overactive bladder symptom score (OABSS), uroflowmetric parameters, and the frequency volume chart. Results There was not a significant difference between the two groups in the chronological changes in IPSS and OABSS for 12 months after implantation. Regarding the frequency volume chart assessment, the mean daytime urinary frequency in the combination group at 3 and 6 months after implantation was significantly lower than that in the monotherapy group. Regarding IPSS recovery at 3 months after implantation, higher baseline IPSS and nonuse of external beam radiation therapy were independent factors, while smaller prostate volume and higher baseline IPSS were independent factors of IPSS recovery at 12 months after implantation based on multivariate analyses. Conclusions There was not an additional effect of a COX-2 inhibitor to the action of an alpha-1 adrenoceptor antagonist on concerning the chronological changes in IPSS and OABSS. The use of a COX-2 inhibitor reduced the daytime urinary frequency and postvoid residual after seed implantation.
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comparison of psa value at last follow up of patients who underwent low dose rate Brachytherapy and intensity modulated radiation therapy for prostate cancer
BMC Cancer, 2017Co-Authors: Nobumichi Tanaka, Isao Asakawa, Makito Miyake, Satoshi Anai, Yasushi Nakai, Tomomi Fujii, Masatoshi Hasegawa, Noboru Konishi, Kiyohide FujimotoAbstract:To compare the PSA value at the last follow-up of patients who underwent prostate low-dose rate Brachytherapy (LDR-BT) with that of patients who underwent intensity-modulated radiation therapy (IMRT). A total of 610 prostate cancer patients (cT1c-3bN0M0) were enrolled, and 445 of them underwent LDR-BT, while 165 received IMRT (74–76 Gy). The median follow-up period of these two groups was 75 months (LDR-BT) and 78 months (IMRT), respectively. We also evaluated the biochemical recurrence (BCR)-free rate using two definitions (Phoenix definition and PSA ≥ 0.2 ng/mL). The percentage of patients who achieved PSA < 0.2 ng/mL at the last follow-up was 77.5% in the LDR-BT group and 49.7% in the IMRT group (p < 0.001). Among patients with a normal testosterone level at the last follow-up, the percentage of those who achieved PSA < 0.2 ng/mL at the last follow-up was 79.2% in the LDR-BT group and 32.1% in the IMRT group (p < 0.001). The 5-year BCR-free rate by the Phoenix definition in the IMRT and LDR-BT groups was 89.5 and 95.0% (p < 0.001), respectively. On the other hand, the 5-year BCR-free rate using the definition of PSA ≥ 0.2 ng/mL was 59.1 and 80.1% in the IMRT and LDR-BT groups, respectively (p < 0.001). The PSA value at the last follow-up of LDR-BT was significantly lower than that of IMRT, and this result was particularly marked in patients with a normal testosterone level at the last follow-up.
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use of alpha 1 adrenoceptor antagonists in patients who underwent low dose rate Brachytherapy for prostate cancer a randomized controlled trial of silodosin versus naftopidil
Radiation Oncology, 2014Co-Authors: Nobumichi Tanaka, Kazumasa Torimoto, Isao Asakawa, Makito Miyake, Satoshi Anai, Masatoshi Hasegawa, Noboru Konishi, Akihide Hirayama, Kiyohide FujimotoAbstract:Background To evaluate the effect of two different alpha-1 adrenoceptor antagonists on lower urinary tract symptoms in patients who underwent LDR-Brachytherapy.
