Background Moderate hypofractionated radiotherapy is a treatment option for the cure of localized prostate cancer (PCa) patients based on the results of randomized prospective trials, but there is a clinical concern about the relatively short length of follow-up, and real-world results on outcome and toxicity based on cutting-edge techniques are lacking. The objective of this study is to present the long-term results of a large multicentric series. Materials and methods We retrospectively evaluated 1325 PCa patients treated with daily volumetric image-guided hypofractionated radiotherapy between 2007 and 2020 in 16 Centers. For survival endpoints, we used Kaplan–Meier survival curves and fitted univariate and multivariable Cox’s proportional hazards regression models to study the association between the clinical variables and each survival type. Results At the end of the follow-up, 11 patients died from PCa. The 15-year values of cancer-specific survival (CSS) and biochemical relapse-free survival (b-RFS) were 98.5% (95%CI 97.3–99.6%) and 85.5% (95%CI 81.9–89.4%), respectively. The multivariate analysis showed that baseline PSA, Gleason score, and the use of androgen deprivation therapy were significant variables for all the outcomes. Acute gastrointestinal (GI) and genitourinary (GU) toxicities of grade ≥ 2 were 7.0% and 16.98%, respectively. The 15-year late grade ≥ 2 GI and GU toxicities were 5% (95%CI 4–6%) and 6% (95%CI 4–8%), respectively. Conclusion Real-world long-term results of this multicentric study on cutting-edge techniques for the cure of localized PCa demonstrated an excellent biochemical-free survival rate of 85.5% at 15 years, and very low rates of ≥ G3 late GU and GI toxicity (1.6% and 0.9% respectively), strengthening the results of the available published trials.

Purpose/Objective(s) To report the results of a phases 1 and 2 study on stereotactic body radiation therapy (SBRT) for early glottic cancer. Methods and Materials This a prospective study at a single institution enrolling patients with T1 glottic cancer. The true vocal cords (TVCs) were divided into thirds and the third(s) containing disease prescribed 36 Gy in 3 fractions. The portions of the TVCs next to the involved one were planned to receive 30 Gy in 3 fxs. SBRT was delivered by a linear accelerator-based approach using multiple arcs. Toxicity was scored by Common Terminology Criteria for Adverse Events and late events were considered those occurring 3 months after SBRT. Voice quality was investigated by the Voice Handicap Index at regular intervals. The planned sample size was 75 patients. Results Accrual was discontinued after 33 patients because of concerns for late toxicity. T stage was as follows: T1a: 23 patients (69.7%); T1b: 10 patients (30.3%). All patients received the planned treatment and the median follow-up time was 51.5 months (IQR, 47.9-61.0 months). At last follow-up, all patients were alive and without evidence of disease but 2 patients who died for intercurrent causes. The local control rate was 100% at 4 years. Six patients (18.2%) developed soft tissue necrosis (N = 4) or cartilage necrosis (N = 2) after a median time of 14.9 months from SBRT. Five out of 6 necrotic events were observed in patients who kept smoking and/or had a recent COVID infection. All 4 soft tissue events healed with conservative therapy. After an initial deterioration, the average Voice Handicap Index score significantly improved at 6 months over baseline. Conclusions SBRT to 36 Gy in 3 fractions is highly effective in controlling T1 TVC carcinoma, but necrosis, although mostly transient, is a concern. On the basis of the present results, a reduction in total dose and a more accurate patient selection are warranted.

ABSTRACT The impact of radiotherapy (RT) on immune cell status in prostate cancer (PCa) is only partially determined. The aim of this study was to assess the effect of different RT strategies on peripheral B, T, and Natural killer (NK) lymphocytes at precise longitudinal time-points in PCa. 18 patients treated with stereotactic body radiation therapy (SBRT) (40 Gy/3FRX), definitive moderate-hypofractionation (62 Gy/20FRX), or post-operative conventional-fractionation RT (66–69 Gy/30FRX) were prospectively evaluated for the immune cell profile in terms of immune cell composition, differentiation stage, cytokine production and inhibitory receptor (IR) expression. The immune-monitoring of the 18 patients revealed that RT affects the balance of systemic immune cells, with the main differences observed between SBRT and conventionally fractionated RT. SBRT favorably impacts immune response in term of increased B cells, central-memory and effector-memory CD8+ T cells, along with decreased Treg cells after treatment. On the contrary, conventional fractionated RT had a long-term negative effect on the systemic immune profile, including a decrease of total lymphocyte counts accompanied by an increase of neutrophils-to-lymphocytes ratio. Total B and T cells decreased and Treg-to-CD8+ ratio increased. Functionality of T lymphocytes were not affected by any of the 3-fractionation schedules. Interestingly, SBRT significantly up-regulates the expression of V-domain immunoglobulin suppressor of T-cell activation (VISTA) in CD8+ T cells in the absence of other IRs. Our results indicate the relevance of systematic immunomonitoring during RT to identify novel immune-related target to design trials of combined radio-immunotherapy as a promising strategy in the clinical management of PCa.

Background: To investigate the predictive role of dynamic contrast-enhanced-magnetic resonance imaging (DCE-MRI) findings before salvage radiotherapy after radical prostatectomy (RP). Methods: This retrospective study selected patients with biochemical failure (BF) after RP restaged with DCE-MRI. Patients underwent sRT in 30 fractions delivering 66–69 Gy and 73.5 Gy to the prostatic fossa and to the local failure as per DCE-MRI, respectively. Pelvic nodes were treated to 54 Gy in selected patients. The endpoint was BF after sRT. Results: In total, 236 patients were analyzed and 146 (61.9%) had presumed local failure at DCE-MRI: 54.8%, 23.8% and 21.4% were found at the vesico-urethral anastomosis (VUA), the bladder neck and the retro-vesical space, respectively. The presence of a local failure at DCE-MRI halved the risk of BF; VUA-only location and lesion volume were independently correlated with survival without evidence of biochemical failure (bNED) at multivariable analysis. For patients with VUA-only disease up to 0.4 cc, the 4-year-bNED was 94.6% (95%CI: 80.2–98.6%) as opposed to 80.9% (95%CI: 71.6–87.4%) and 73.7% (95%CI: 63.1–81.8%) for other lesions and no macrodisease, respectively. Conclusions: DCE-MRI at restaging for BF after RP provides predictive and therapeutic information. Patients with small lesions at the VUA have an excellent prognosis after sRT.

PURPOSE:Erectile dysfunction (ED) is a common side effect after prostate cancer stereotactic body radiation therapy (SBRT). We aimed to assess the correlation between the dose to the penile bulb (PB), internal pudendal arteries (IPA), and crura with the development of ED after ultrahypofractionation as part of a phase 2 clinical trial of urethra-sparing prostate SBRT. METHODS AND MATERIALS:Among the 170 patients with localized prostate cancer from 9 centers included in the trial, 90 men with Common Terminology Criteria for Adverse Events version 4.03 grade 0 to 1 ED (ED-) at baseline treated with 36.25 Gy in 5 fractions were selected for the present analysis. Doses delivered to the PB, crura, and IPA were analyzed and correlated with grade 2 to 3 ED (ED+) development. The effect on quality of life, assessed by the European Organisation for Research and Treatment of Cancer (EORTC QLQ-PR25) questionnaire, was reported. RESULTS:After a median follow-up of 6.5 years, 43% (n = 39) of the patients developed ED+, and 57% (n = 51) remained ED-. The dose delivered to the crura was significantly higher in ED+ patients than in ED- patients (7.7 vs 3.6 Gy [P = .014] for the Dmean and 18.5 vs 7.2 Gy [P = .015] for the D2%, respectively). No statistically significant difference between ED+ and ED- patients was observed for the dose delivered to the PB and IPA. The median ED+-free survival was worse in patients receiving a crura Dmean ≥ 4.7 versus < 4.7 Gy (51.5% vs 71.7%, P = .005) and a crura D2% > 12 versus ≤ 12 Gy (54.9% vs 68.9%, P = .015). No ED+-free survival differences were observed for doses delivered to the PB and IPA. Decline in EORTC QLQ-PR25 sexual functioning was significantly more pronounced in patients with higher doses to the crura. CONCLUSIONS:By keeping a Dmean and D2% to crura below 4.7 and 12 Gy, respectively, the risk of developing ED+ after prostate SBRT may be significantly reduced.

We investigated how hypofractionated radiotherapy (HFRT) and stereotactic body radiotherapy (SBRT) may impact immune cells in different type of tumors. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The PubMed, Embase and Cochrane databases were searched. Overall, 11 studies met the inclusion criteria and were eligible for the present analysis. Both HFRT and SBRT have different impact on lymphocyte subpopulations, confirming their immunomodulatory effect which may have a crucial role in future combined treatment with new emergent therapies such as immunotherapy. Further studies are needed to shed more light on this emerging topic to ultimately improve patient care, treatment and clinical benefits for cancer patients.

Background: To assess the pattern of response of presumed local lesions at dynamic contrast enhancement magnetic resonance imaging (DCE-MRI) after salvage radiotherapy (sRT). Methods: This is a prospective study conducted at a single Institution accruing patients with one or more local failures at DCE-MRI after radical prostatectomy between August 2017 and June 2020. Patients underwent exclusive sRT delivering 66–69 Gy and 73.5 Gy in 30 fractions to the whole prostatic fossa and to the local failure(s) seen at DCE-MRI, respectively.Patients were offered DCE-MRI at 3 months intervals after sRT until complete disappearance (CR) of the lesion(s) or up to a maximum of 4 revaluations. Results: 62 patients with 72 nodules were enrolled. All patients underwent the 1st revaluation, and 33 patients (53.2%) showed a CR. The median time to CR was 4.7 months. Four patients did not undergo further testing before achieving a CR and even considering these patients as no responses, the vast majority (87.1%, 95%CI: 78.5–94.4%) of lesions would have completely disappeared by 12 months from the end of sRT.The volume of the lesion at pre-sRT DCE-MRI was an independent predictor of CR at the 1st revaluation (OR: 0.076, 95%CI: 0.009–0.667; p = 0.020) along with time elapsed from sRT (OR: 3.399, 95% CI: 1.156–9.993, p = 0.026). Conclusions: The present study documents the complete disappearance of the vast majority of local lesions after dose-escalated sRT though this requires several months after sRT; timing of CR is at least in part predictable based on the volume of the lesion.Trial registration: Clinicaltrials.gov NCT04703543, registered July 15 2020, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04703543.

Prostate cancer is the second most common cause of cancer-related mortality in men. In patients undergoing a failure after radical treatment, one of the therapeutic option is androgen deprivation: despite initial response rates, a progression to a state of castration resistance is observed in most of the patients. In the present article, we conducted a systematic review and meta-analysis of all clinical trials assessing treatment for nmCRPC with next-generation androgen receptor inhibitors. We performed a review and meta-analysis of phase III randomized controlled trials comparing new agents (apalutamide, enzalutamide, darolutamide) with placebo as control arm, in the setting of nmCRPC. Patients treated with next-generation ARIs had a 26% reduction in the risk of death compared with placebo; compared with other ARIs, darolutamide had the lowest rate of grade 3 and 4 AEs and the lowest therapy discontinuation rate due to any grade AEs. This meta-analysis shows that treatment with new ARIs is safe and significantly reduces the risk of death and of metastasis onset in nmCRPC patients. Under way studies on new biomarkers such as genomic classifiers will probably allow the stratification in more specific subsets of disease. New imaging modalities such as PSMA-PET have shown greater sensibility and specificity than conventional imaging in metastases detection. All patients were randomized in a 2:1 fashion, with a total of 2,694 who underwent next-generation ARIs (806 apalutamide, 955 darolutamide, 933 enzalutamide) and 1,423 in the placebo arm.

Purpose/Objective(s) To investigate predictors of biochemical failure after salvage radiotherapy (sRT) in the context of a presumed local failure at dynamic contrast-enhancement-magnetic resonance imaging (DCE-MRI) post radical prostatectomy (RP). Materials/Methods All patients referred for sRT at our Institution with a biochemical failure after RP have been consistently offered restaging with both PET/CT and multiparametric MRI since January 2014. Those with a presumed local failure at DCE-MRI as well as no regional/distant disease at PET/CT (either choline and/or PSMA) were selected for the present study. Exclusion criteria were history of androgen deprivation (AD) before sRT and positive nodes at RP. All patients underwent 3T DCE-MRI without endorectal coil and the lesion(s) transferred to the planning CT after co-registration. sRT consisted in 73.5 Gy to the presumed local lesion and 66-69 Gy to the prostatic bed in 30 fxs. Pelvic nodes (PN) were covered to 54 Gy/30 fxs in selected patients. The endpoint of the study was the development of a biochemical failure after sRT defined as a 0.2 ng/ml PSA rise above the nadir. Various covariates (age, pre-RP PSA, pT and pN stages at RP, margins status at RP, ISUP grade group, time from RP to sRT, PSA doubling time, PSA detectability after RP, PSA at sRT, the location, number and volume of the detected recurrence(s), AD use, PN coverage, EUA risk category) were investigated at univariate analysis (UVA) on the time to biochemical failure (bNED-survival). Covariates with a p value <0.2 at UVA were entered a Cox proportional hazards regression analysis. Results Up to June 2020, 146 patients satisfying all selection criteria have been treated with sRT. Median (IQR) PSA at sRT was 0.60 ng/ml (0.38-1.05 ng/ml) and only 17 patients (11.6%) received AD along with sRT. A total of 168 local lesions have been detected, 92 (54.8%), 40 (23.8%) and 36 (21.4%) at the vesicourethral anastomosis (VUA), the bladder neck and the retrovesical space, respectively. At the median (IQR) follow-up of 48.1 months (31.3-60.6 months), 22 biochemical failures have been observed for a 4-yr bNED survival of 84.4% (95%CI: 77.9-90.9%). On UVA, bNED-survival after sRT was significantly more likely for patients with VUA-only lesions (VUA-only vs others, HR=0.307, 95%CI: 0.120-0.784, p=0.014) and with smaller lesions (for every cc, HR: 1.071, 95%CI: 1.025-1.119, p=0.002). These associations remained significant (p< 0.01) on multivariate analysis as well. For patients with VUA-only disease or with lesions smaller than 0.5cc, 4-yr bNED survival rates were 90.7% (95%CI: 83.4-98.0%) and 90.6% (95%CI: 83.9-97.3%), respectively. The 46 patients with both favorable features had a 4-yr bNED rate of 94.6% (95%CI: 87.3-100%). Conclusion These data support local restaging with DCE-MRI before sRT in the setting of a biochemical failure after RP. Patients with VUA-only and/or small volume lesions have an excellent outcome after dose-escalated sRT.

Background: We aimed assess the detection rate (DR) of positron emission tomography/computed tomography with two novel tracers in patients referred for salvage radiotherapy (sRT) with a presumed local recurrence at multiparametric magnetic resonance (mpMR) after radical prostatectomy (RP). Methods: The present prospective study was conducted at a single institution between August 2017 and June 2020. Eligibility criteria were undetectable PSA after RP; subsequent biochemical recurrence (two consecutive PSA rises to 0.2 ng/mL or greater); a presumed local failure at mpMR; no distant metastases at 18F-fluorocholine PET/CT (CH/PET); no previous history of androgen deprivation therapy. Patients were offered both 64CuCl2 PET/CT (CU/PET) and 64Cu-PSMA PET/CT (PSMA/PET) before sRT. After image co-registration, PET findings were compared to mpMR ones in terms of DR and independent predictors of DR investigated at logistic regression. Results: A total of 62 patients with 72 nodules at mpMR were accrued. Compared to mpMR (DR = 100%, 95%CI: 94.9–100%), DRs were 47.2% (95%CI: 36.1–58.6%) and 54.4% (95%CI: 42.7–65.7%) for CU/PET and PSMA/PET, respectively (p < 0.001 for both). Both experimental PET/CT performed particularly poorly at PSA levels consistent with early sRT. Conclusions: The two novel radiotracers are inferior to mpMR in restaging the prostatic fossa for sRT planning purposes, particularly in the context of early salvage radiotherapy.

Background:Radiotherapy is an emerging treatment strategy for nodal oligorecurrent prostate cancer (PCa) patients. However, large heterogeneities exist in the RT regimens used, with series reporting the use of elective nodal radiotherapy (ENRT) strategies and others the delivery of focal treatments to the relapsing nodes with Stereotactic Body Radiotherapy (SBRT). In this systematic review of the literature we compared the oncological outcomes and toxicity of the different RT regimens for nodal oligorecurrent PCa patients, with the aim of defining the optimal RT target volume in this setting. Methods:We performed a systemic search on the Pubmed database to identify articles reporting on the use of ENRT or SBRT for oligometastatic PCa with nodal recurrence. Results:Twenty-two articles were analyzed, including four prospective phase II trials (3 with SBRT and 1 with ENRT). Focal SBRT, delivered with an involved node, involved site, and involved field modality, was the most commonly used strategy with 2-year progression-free survival (PFS) rates ranging from 16 to 58% and a very low toxicity profile. Improved PFS rates were observed with ENRT strategies (52-80% at 3 years) compared to focal SBRT, despite a slightly higher toxicity rate. One ongoing randomized phase II trial is comparing both modalities in patients with nodal oligorecurrent PCa. Conclusions:With a large variability in patterns of practice, the optimal RT strategy remains to be determined in the setting of nodal oligorecurrent PCa. Ongoing randomized trials and advances in translational research will help to shed light on the best management for these patients. .

PURPOSE:Our purpose was to assess the ability of electromagnetic transponders (EMTs) to localize and track movements in patients with prostate cancer (PCa) with metallic hip prostheses (MHPs) treated with curative radiation therapy (RT).METHODS AND MATERIALS:Data sets of 8 PCa patients with MHPs (3 bilateral and 5 unilateral) treated between 2016 and 2018 with RT and EMT tracking were retrospectively assessed. The distances between the 3 EMTs (apex to left, left to right, right to apex) and the isocenter were calculated both on planning computed tomography (CT) and cone beam CT (CBCT) at the first treatment fraction and compared with data reported by Calypso. EMT position and treatment interruptions triggered by Calypso were analyzed for all evaluable treatment fractions (n = 120). Localization accuracy was quantified by recording the geometric residual value (expected limit ≤0.2 cm) at the RT setup.RESULTS:The Calypso system was able to localize and track prostate position without any detectable interference from MHP. For every treatment fraction, the agreement between the CBCT images and Calypso guidance was optimal, with EMTs always within the defined tolerance (ie, CT-Calypso or CBCT-Calypso measured differences in inter-EMT distances within 0.3 cm). EMT to isocenter distances measured by Calypso reproduced CT data and were confirmed on CBCT scans. During RT, the EMT centroid exceeded the threshold 24 times (20% of all fractions): 5 times in the left-right, 15 times in the anteroposterior, and 4 times in the superoinferior directions. The largest motions recorded were in the anteroposterior axis: 0.6 cm anteriorly and 0.5 cm posteriorly in patients with unilateral and bilateral MHP, respectively.CONCLUSIONS:Our study represents the first clinical experience assessing the localization and tracking accuracy of Calypso EMTs during curative RT of patients with PCa with unilateral or bilateral MHP.

Context: Different nonsurgical therapeutic strategies can be adopted for intraprostatic relapse of prostate cancer after primary radiotherapy, including re-irradiation (with brachytherapy [BT] or external beam radiotherapy [EBRT]), highintensity focused ultrasound (HIFU), and cryotherapy. The main issues to consider when choosing nonsurgical salvage local therapies are local tumor control and significant genitourinary toxicity. Objective: To conduct a systematic review and meta-analysis of the role of nonsurgical salvage modalities in patients with radiorecurrent prostate cancer and associated clinical outcomes and toxicity profiles. Evidence acquisition: We performed a critical review of the Medline, Scopus, and ClinicalKey databases from January 1, 2000 through February 1, 2018 according to the Preferred Reporting Items and Meta-Analyses statement. To assess the overall quality of the literature reviewed, we used a modified Delphi tool for case-series studies. Evidence synthesis: A total of 64 case-series studies were included, corresponding to a cohort of 5585 patients. The modified Delphi checklist evidenced high methodological quality overall (mean quality score of 80.6%). Biochemical control rates were lowest for patients treated with HIFU (58%, 95% confidence interval [CI] 47-68%) and highest for patients treated with BT (69%, 95% CI 62-76%) and EBRT (69%, 95% CI 53-83%). The lowest prevalence of incontinence was for patients treated with BT (3%, 95% CI 0-6%; I-2 = 63.4%) and the highest was among patients treated with HIFU (28%, 95% CI 19-38%; I-2 = 89.7%). Conclusions: Nonsurgical therapeutic options, especially BT, showed good outcomes in terms of biochemical control and tolerability in the local recurrence setting. Patient summary: The current analysis demonstrated that nonsurgical salvage local therapies offer a chance of a curative local approach in radiorecurrent prostate cancer. However, high-quality data from prospective trials are needed to validate long-term outcomes from nonsurgical strategies for the treatment of intraprostatic recurrence after previous radiotherapy. (C) 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Elderly breast cancer patients are frequently affected by significant comorbidities that make sophisticated radiotherapy treatments particularly challenging. We dosimetrically analyzed two different simple free-breathing external beam radiotherapy (EBRT) techniques for the hypofractionated treatment of the left breast in elderly patients with a low compliance, to compare target coverage, and heart and left anterior descending coronary artery (LADCA) sparing. We developed radiation plans for 24 elderly patients using 3D conformal (3DCRT) field-in-field tangential technique and intensity-modulated (IMRT) tangential beam technique. Dose-Volume-Histograms (DVHs) were used to provide a quantitative comparison between plans. The median breast volume was 645 cm3. IMRT and 3DCRT plans comparison demonstrated no significant differences in terms of organ sparing for the heart. Regarding LADCA, mean dose (10.3 ± 9.5 Gy vs 11.9 ± 9.6 Gy, p = 0.0003), maximum dose (26.1 ± 16.1 Gy vs 29.1 ± 16.1 Gy, p = 0.004) and V17 Gy (21.5% ± 26.9% vs 25.0% ± 27.2%, p = 0.002) significantly decreased using IMRT compared with 3DCRT. IMRT plans showed a better target coverage compared with 3DCRT (0.91 ± 0.05 vs 0.93 ± 0.04, p = 0.05). Comparing the two different EBRT techniques, we demonstrated few, although substantial, dosimetric differences in terms of doses to the organs at risk characterized by a statistically significant dose reduction of LADCA in the IMRT plans. Elderly patients with a low compliance to treatment might benefit from 3DCRT with field-in-field tangential arrangement or from a simple IMRT approach. IMRT should be preferred.

With this review, we aimed to describe the role of adjuvant radiotherapy in the therapeutic management of metastatic inflammatory breast cancer, a rare and aggressive disease historically characterized by high rates of recurrence and poor prognosis. In the context of a multimodality approach, Post-Mastectomy Radiotherapy (PMRT) affirms its role as an appriopriate treatment strategy to improve loco-regional tumor control in selected patients. Further validation in prospective trials is required to better define a standardized therapeutic management of this disease.

Historically bladder cancer (BC) has been diagnosed with transurethral resection (TUR) (1), which is the gold standard, and imaging was not considered very useful to assess the invasiveness of BC. Computed tomography urography is generally used for BC staging but has a poor spatial resolution and provides only few details about tumor invasion into the muscolaris propria.

Papillary tumor of the pineal region (PTPR) is a rare neuroepithelial brain tumor, characterized by a high risk of local recurrence (greater than 70 % at 6 years). The aim of our study was to review the available literature on radiotherapy for PTPR in order to evaluate timings, schedules, outcomes and toxicities of this treatment modality. In our review, 72.4 % (84) of the patients diagnosed with PTPR received radiation therapy. There is heterogeneity in the dose prescription, ranging from 45 Gy (25 x 1.8 Gy) to 60 Gy (30 x 2 Gy) for 3D Conformal Radiation Therapy and from 12 Gy to 36 Gy for Stereotactic Radiosurgery. Being considered as a grade II or III tumor, PTPR should receive higher total radiation dose in the adjuvant setting. Our analysis showed a very limited treatment-related toxicity with an expected 10-y OS of 72.5 %. At 5-years from the diagnosis, about 60 % of the patients experienced a local recurrence, whereas at 10 years the rate is higher than 80 %. In the literature, conflicting data about radiotherapy for PTPR are reported, in particular regarding disease progression. Although radiotherapy represents a fundamental treatment in the management of PTPR, prospective studies are required to better define its impact on overall survival and progression-free survival.

Aim: To identify factors influencing toxicity in patients affected by localized prostate cancer treated with conformal image-guided radiotherapy. Background: Image guidance in combination with conformal techniques is the standard of care in localized prostate cancer, but factors affecting toxicity are still under investigation. Materials and methods: 294 patients were analyzed. Median age at diagnosis was 71 year. 76 Gy (38 x 2 Gy) were delivered to the target volume. We used the chi(2) test to analyse associations between toxicity and dosimetric and clinical parameters. Multivariate analysis was performed using binary logistic regression. Kaplan-Meier method was used for survival analysis. Results: Median follow-up was 62.9 months. Acute grade >= 2 gastro-intestinal toxicity (GI) was 12.1%. Acute genito-urinary (GU) toxicity of grade >= 2 was 33.9%. Actuarial 4 and 5 years late grade >= 2 GI was 3% and 4%, respectively. Four and 5-year late grade >= 2 GU toxicity was 6% and 10%. At multivariate analysis for acute toxicity rectal V-70 was correlated with GI toxicity (p = 0.01, HR 2.73 CI 1.19-6.26), and smoking habit with GU toxicity (p < 0.01, HR 2.50 CI 1.51-4.14). For late toxicity, rectal V-70 was correlated with gastro-intestinal toxicity (p = 0.04, HR 4.76 CI 1.07-21.13), and pre-radiotherapy urinary symptoms with genito-urinary toxicity (p = 0.01, HR 2.84 CI 1.29-6.22). Discussion: Conformal image-guided radiotherapy shows low rates of toxicity. Smoking should be avoided during radiotherapy. Besides the evaluation of high doses received by the organs at risk, individual factors, such as co-morbidities and lifestyle choices, have an impact on normal-tissue complication risk. (C) 2018 Greater Poland Cancer Centre. Published by Elsevier Sp. z o.o. All rights reserved.