Salvage-Radiation Therapy and Regional Hyperthermia for Biochemically Recurrent Prostate Cancer after Radical Prostatectomy (Results of the Planned Interim Analysis)

Simple Summary: Several efforts like dose-escalated salvage radiation therapy and the use of androgen deprivation therapy aimed to improve the postoperative treatment in patients with biochemical recurrence of prostate cancer after prostatectomy. However, the oncological outcome is still not satisfactory. Hyperthermia is well-known to improve the efficacy of radiation therapy, whereas only limited data for postoperative therapy in prostate cancer are available. Thus, we conducted a prospective multicenter non-randomized Phase-II-Trial (HTProstate) investigating the implementation of combined salvage radiation therapy and regional hyperthermia in case of biochemical recurrence after prostatectomy with the aim to evaluate the safety, feasibility, and oncological outcome of this approach. The results of our planned interim analysis (n = 50) met the criteria of safety (only one patient with acute grade 3 hyperthermia-specific toxicity), showed feasibility of planned radiation and hyperthermia therapy, no significant changes in quality of life and promising short-term prostate-specific antigen response. Late toxicity and robust oncological outcome data will be reported after completion of the trial. Abstract: Efforts to improve the outcome of prostate cancer (PC) patients after radical prostatectomy (RP) include adjuvant or salvage radiation therapy (SRT), but still up to 50% of patients develop a disease progression after radiotherapy (RT). Regional hyperthermia (HT) is well-known to improve tumor sensitivity to RT in several entities. Here we report on a planned interim analysis of tolerability and feasibility after recruitment of the first 50 patients of a trial combining SRT and HT. We conducted a prospective multicenter non-randomized Phase-II-Trial (HTProstate-NCT04159051) investigating the implementation of combined moderate-dose escalated SRT (70 Gy in 35 fractions) and locoregional deep HT (7-10 HT sessions). The primary endpoints were the rate of acute genitourinary (GU), gastrointestinal (GI), and HT-related toxicities, completed HT sessions (≥7), and SRT applications per protocol (≥95% of patients). The two-step design included a planned interim analysis for acute GU-, GI- and HT-specific toxicities to ensure patients' safety. Between November 2016 and December 2019, 52 patients entered into the trial. After 50 patients completed therapy and three months of follow-up, we performed the planned interim analysis. 10% of patients developed acute grade 2 GU and 4% grade 2 GI toxicities. No grade ≥3 GU or GI toxicities occurred. HT-specific symptoms grade 2 and 3 were observed in 4% and 2% of all patients. Thus, the pre-specified criteria for safety and continuation of recruitment were met. Moreover, ≥7 HT treatments were applicable, indicating the combination of SRT + HT to be feasible. Evaluation of early QoL showed no significant changes. With its observed low rate of GU and GI toxicities, moderate and manageable rates of HT-specific symptoms, and good feasibility, the combined SRT + HT seems to be a promising treatment approach for biochemical recurrence after RP in PC patients

Salvage-Radiation Therapy and Regional Hyperthermia for Biochemically Recurrent Prostate Cancer after Radical Prostatectomy (Results of the Planned Interim Analysis)

Efforts to improve the outcome of prostate cancer (PC) patients after radical prostatectomy (RP) include adjuvant or salvage radiation therapy (SRT), but still up to 50% of patients develop a disease progression after radiotherapy (RT). Regional hyperthermia (HT) is well-known to improve tumor sensitivity to RT in several entities. Here we report on a planned interim analysis of tolerability and feasibility after recruitment of the first 50 patients of a trial combining SRT and HT. We conducted a prospective multicenter non-randomized Phase-II-Trial (HTProstate-NCT04159051) investigating the implementation of combined moderate-dose escalated SRT (70 Gy in 35 fractions) and locoregional deep HT (7–10 HT sessions). The primary endpoints were the rate of acute genitourinary (GU), gastrointestinal (GI), and HT-related toxicities, completed HT sessions (≥7), and SRT applications per protocol (≥95% of patients). The two-step design included a planned interim analysis for acute GU-, GI- and HT-specific toxicities to ensure patients’ safety. Between November 2016 and December 2019, 52 patients entered into the trial. After 50 patients completed therapy and three months of follow-up, we performed the planned interim analysis. 10% of patients developed acute grade 2 GU and 4% grade 2 GI toxicities. No grade ≥3 GU or GI toxicities occurred. HT-specific symptoms grade 2 and 3 were observed in 4% and 2% of all patients. Thus, the pre-specified criteria for safety and continuation of recruitment were met. Moreover, ≥7 HT treatments were applicable, indicating the combination of SRT + HT to be feasible. Evaluation of early QoL showed no significant changes. With its observed low rate of GU and GI toxicities, moderate and manageable rates of HT-specific symptoms, and good feasibility, the combined SRT + HT seems to be a promising treatment approach for biochemical recurrence after RP in PC patients

First Experience with the Standard Diagnostics at the European XFEL Injector

International audienceThe injector of the European XFEL is in operation since December 2015. It includes, beside the gun and the accelerating section, containing 1.3 and a 3.9 GHz accelerating module, a variety of standard diagnostics systems specially designed for this facility. With very few exceptions, all types of diagnostics systems are installed in the injector. Therefore the operation of the injector is served to validate and prove the diagnostics characteristics for the complete European XFEL. Most of the standard diagnostics has been available for the start of beam operation and showed the evidence of first beam along the beam line. In the following months the diagnostics has been optimized and used for improvements of beam quality. First operational experiences and results from the standard beam diagnostics in the injector of the European XFEL will be reported in this contribution