scholarly journals Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Geumju Park ◽  
Yeon Joo Kim ◽  
Hanjong Ahn ◽  
Won Park ◽  
Ji sung Lee ◽  
...  

Abstract Background While several phase III trials have investigated the role of hypofractionated radiotherapy in the definitive treatment of localized prostate cancer, prospective data reporting the outcomes of hypofractionated radiotherapy in the postoperative treatment setting are sparse. Therefore, this study is designed to assess the efficacy and treatment-related toxicity of hypofractionated salvage radiotherapy for the treatment of biochemical recurrence in men who underwent radical prostatectomy. The primary objective of this trial is to investigate whether hypofractionated radiotherapy improves biochemical control compared with conventionally fractionated radiotherapy. In addition, treatment-related toxicity, quality of life, and survival will be evaluated as secondary endpoints. Methods In this prospective, randomized, multi-institutional trial (the SHARE study), patients with intermediate- or high-risk prostate cancer will be randomized to receive either hypofractionated radiotherapy (65 Gy in 2.5-Gy fractions) or conventionally fractionated radiotherapy (66 Gy in 2-Gy fractions). Prostate bed irradiation or elective pelvic nodal irradiation including the prostate bed will be performed using intensity-modulated radiotherapy and daily image guidance. Treatment efficacy will be assessed using the serum tumor marker prostate-specific antigen, and toxicity will be evaluated through both physician- and patient-reported outcomes. Quality of life will also be investigated. Discussion This study is designed to demonstrate whether hypofractionated radiotherapy is beneficial in terms of biochemical control and toxicity compared with standard salvage radiotherapy. If hypofractionated radiotherapy is shown to be superior to conventionally fractionated radiotherapy, it will mean that improved biochemical control can be achieved, accompanied by greater patient convenience and more efficient use of medical resources. Trial registration ClinicalTrials.gov NCT03920033. Registered on 18 April 2019

2017 ◽  
Vol 51 (6) ◽  
pp. 457-463 ◽  
Author(s):  
Maria Ervandian ◽  
Morten Høyer ◽  
Stine Elleberg Petersen ◽  
Lisa Sengeløv ◽  
Steinbjørn Hansen ◽  
...  

Cancers ◽  
2021 ◽  
Vol 13 (22) ◽  
pp. 5636
Author(s):  
Michael Chaloupka ◽  
Lina Stoermer ◽  
Maria Apfelbeck ◽  
Alexander Buchner ◽  
Vera Wenter ◽  
...  

(1) Background: local treatment of the primary tumor has become a valid therapeutic option in de-novo oligo-metastatic prostate cancer (PC). However, evidence regarding radical prostatectomy (RP) in this setting is still subpar, and the effect of cytoreductive RP on postoperative health-related quality of life (HRQOL) is still unclear. (2) Methods: for the current study, patients with de-novo oligo-metastatic PC (cM1-oligo), defined as ≤5 bone lesions in the preoperative staging, were included, and matched cohorts using the variables age, body-mass index (BMI), and pT-stage were generated. Patient-reported outcome measures (PROMS) were assessed pre- and postoperatively using the validated EORTC-QLQ-C30, IIEF-5, and ICIQ-SF questionnaires. The primary endpoint for univariate and multivariable analysis was good general HRQOL defined by previously validated cut-off values. (3) Results: in total, 1268 patients (n = 84 (7%) cM1-oligo) underwent RP between 2012 and 2020 at one tertiary care center. A matched cohort of 411 patients (n = 79 with oligo-metastatic bone disease (cM1-oligo) and n = 332 patients without clinical indication of metastatic disease (cM0)) was created. The median follow-up was 25mo. There was no significant difference in good general HRQOL rates between cM1-oligo-patients and cM0-patients before RP (45.6% vs. 55.2%, p = 0.186), and at time of follow-up (44% vs. 56%, p = 0.811). Global health status (GHS) worsened significantly in cM0-patients compared to baseline (−5, p = 0.001), whereas GHS did not change significantly in cM1-oligo-patients (+3.2, p = 0.381). In multivariate analysis stratified for good erectile function (IIEF5 > 18; OR 5.722, 95% CI 1.89–17.36, p = 0.002) and continence recovery (OR 1.671, 95% CI 1.03–2.70, p = 0.036), cM1-oligo was not an independent predictive feature for general HRQOL (OR 0.821, 95% CI 0.44–1.53, p = 0.536). (4) Conclusions: in this large contemporary retrospective analysis, we observed no significant difference in HRQOL in patients with the oligometastatic bone disease after cytoreductive radical prostatectomy, when compared to patients with localized disease at time of surgery.


2018 ◽  
Author(s):  
Louis A Aliperti ◽  
Martin G Sanda ◽  
Christopher P Filson

With a long survivorship phase after diagnosis and treatment of prostate cancer, consideration of the impact of treatment on health-related quality of life (HRQOL) is critical. For men considering treatment of prostate cancer, the domains that are impacted include urinary, sexual, and bowel-related qualities of life. This review identifies aspects of tools measuring HRQOL and covers instruments used to measure quality of life following a diagnosis and treatment of prostate cancer. We review the impact associated with radical prostatectomy, radiation and brachytherapy, and observation on men diagnosed with prostate cancer and compare the effects that each management strategy has on sexual and urinary function. This review contains 3 figures, 5 tables, 44 references. Key Words: erectile dysfunction, expectant management, lower urinary tract symptoms, prostate cancer, radical prostatectomy, radiation therapy, quality of life, urinary incontinence


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