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• W3211326053 abstract "Purpose/Objective(s)The optimal duration of androgen deprivation (AD) combined with high-dose radiotherapy (HDRT) in prostate cancer remains a matter of controversy. We did a phase 3 trial designed to determine whether long-term AD (LTAD) is superior to short-term AD (STAD) when combined with HDRT. In this report, we present the 10-year survival results. The hypothesis is that long-term AD (LTAD) compared to short-term AD (STAD) improves overall survival among high-risk patients receiving HDRT.Materials/MethodsThis open-label, phase 3 randomized controlled trial, recruited patients from ten university hospitals throughout Spain. Eligibility included patients with cT1c-T3aN0M0 adenocarcinoma of prostate with intermediate and high-risk factors according to NCCN criteria and PSA less than 100 ng/ml. All patients received 4 months of neoadjuvant and concomitant AD (STAD) + HDRT (median radiation dose 78 Gy) before randomization to adjuvant goserelin for two years (LTAD). Stratification was performed according to risk group (intermediate risk [IR] versus high risk [HR]). Study endpoints included overall survival (OS), metastasis free survival (MFS), disease free survival (DFS) and biochemical-disease free survival (bDFS). Survival analyses were done with Kaplan-Meier (KM) curves. Fine & Gray (F&G) regression was used for the adjusted analyses.ResultsFrom 2005 to 2010, 355 patients were randomly assigned to the treatment groups and included in the analysis (178 to STAD and 177 to LTAD). The median follow-up was 119 months (IQR 101-124). The 10-year bDFS for LTAD and STAD was 70.2% and 62.3% respectively (hazard ratio [HR] 1.19, 95% CI, 0.71 to 2.01). The 10-year OS was 78.4% for LTAD and 73.3% for STAD (HR 1.20, 95% CI, 0.79 to 1.82), and the corresponding figure for MFS was 76.0% and 70.9% for LTAD and STAD respectively (HR 1.12, 95% CI, 0.46 to 2.73). For high-risk patients treated with LTAD, the 10-year bDFS was 67.2% compared to 53.7% for STAD (log rank P = 0.03; F&G P = 0.147, HR 1.12 95% CI 0.61 to 2.04). The 10-year OS was 78.5% compared to 67.0% for STAD (log rank, P = 0.056; F&G P = 0.786, HR, 1.18, 95% CI, 0.36 to 3.84) and the 10-year MFS was 76.6% versus 65.0% for LTAD and STAD respectively (log rank P = 0.069; F&G P = 0.057, HR, 1.12, 95% CI, 0.46 to 2.73). Only 11 patients died from PCa, all of them in the high-risk subgroup.ConclusionLong term results failed to show a significant benefit with LTAD compared to STAD in patients treated with HDRT. The subgroup of patients with high-risk PCa treated with LTAD had a non-significant improvement in bDFS, MFS and OS compared with STAD. The relatively small simple size, a low number of events and an effective salvage treatment could be responsible for the lack of a statistical significance. The trial is registered at ClinicalTrials.gov, number NCT 02175212. The optimal duration of androgen deprivation (AD) combined with high-dose radiotherapy (HDRT) in prostate cancer remains a matter of controversy. We did a phase 3 trial designed to determine whether long-term AD (LTAD) is superior to short-term AD (STAD) when combined with HDRT. In this report, we present the 10-year survival results. The hypothesis is that long-term AD (LTAD) compared to short-term AD (STAD) improves overall survival among high-risk patients receiving HDRT. This open-label, phase 3 randomized controlled trial, recruited patients from ten university hospitals throughout Spain. Eligibility included patients with cT1c-T3aN0M0 adenocarcinoma of prostate with intermediate and high-risk factors according to NCCN criteria and PSA less than 100 ng/ml. All patients received 4 months of neoadjuvant and concomitant AD (STAD) + HDRT (median radiation dose 78 Gy) before randomization to adjuvant goserelin for two years (LTAD). Stratification was performed according to risk group (intermediate risk [IR] versus high risk [HR]). Study endpoints included overall survival (OS), metastasis free survival (MFS), disease free survival (DFS) and biochemical-disease free survival (bDFS). Survival analyses were done with Kaplan-Meier (KM) curves. Fine & Gray (F&G) regression was used for the adjusted analyses. From 2005 to 2010, 355 patients were randomly assigned to the treatment groups and included in the analysis (178 to STAD and 177 to LTAD). The median follow-up was 119 months (IQR 101-124). The 10-year bDFS for LTAD and STAD was 70.2% and 62.3% respectively (hazard ratio [HR] 1.19, 95% CI, 0.71 to 2.01). The 10-year OS was 78.4% for LTAD and 73.3% for STAD (HR 1.20, 95% CI, 0.79 to 1.82), and the corresponding figure for MFS was 76.0% and 70.9% for LTAD and STAD respectively (HR 1.12, 95% CI, 0.46 to 2.73). For high-risk patients treated with LTAD, the 10-year bDFS was 67.2% compared to 53.7% for STAD (log rank P = 0.03; F&G P = 0.147, HR 1.12 95% CI 0.61 to 2.04). The 10-year OS was 78.5% compared to 67.0% for STAD (log rank, P = 0.056; F&G P = 0.786, HR, 1.18, 95% CI, 0.36 to 3.84) and the 10-year MFS was 76.6% versus 65.0% for LTAD and STAD respectively (log rank P = 0.069; F&G P = 0.057, HR, 1.12, 95% CI, 0.46 to 2.73). Only 11 patients died from PCa, all of them in the high-risk subgroup. Long term results failed to show a significant benefit with LTAD compared to STAD in patients treated with HDRT. The subgroup of patients with high-risk PCa treated with LTAD had a non-significant improvement in bDFS, MFS and OS compared with STAD. The relatively small simple size, a low number of events and an effective salvage treatment could be responsible for the lack of a statistical significance. The trial is registered at ClinicalTrials.gov, number NCT 02175212." @default.
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• W3211326053 title "10-Year Results of a Phase III Randomized Trial of High-Dose Radiotherapy and Risk-Adapted Androgen Deprivation in Localized Prostate Cancer" @default.
• W3211326053 doi "https://doi.org/10.1016/j.ijrobp.2021.07.187" @default.
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