Extreme Hypofractionation with SBRT in Localized Prostate Cancer.
Ontology highlight
ABSTRACT:
SUBMITTER: Gomez-Aparicio MA
PROVIDER: S-EPMC8395496 | biostudies-literature | 2021 Aug
REPOSITORIES: biostudies-literature
Publications
Extreme Hypofractionation with SBRT in Localized Prostate Cancer.
Gómez-Aparicio Maria Antonia MA Valero Jeannette J Caballero Begoña B García Rafael R Hernando-Requejo Ovidio O Montero Ángel Á Gómez-Iturriaga Alfonso A Zilli Thomas T Ost Piet P López-Campos Fernando F Couñago Felipe F
Current oncology (Toronto, Ont.) 20210803 4
Prostate cancer is the most commonly diagnosed cancer among men around the world. Radiotherapy is a standard of care treatment option for men with localized prostate cancer. Over the years, radiation delivery modalities have contributed to increased precision of treatment, employing radiobiological insights to shorten the overall treatment time, improving the control of the disease without increasing toxicities. Stereotactic body radiation therapy (SBRT) represents an extreme form of hypofractio ...[more]
Similar Datasets
Project description:AimRadiation therapy (RT) is a standard therapeutic option for prostate cancer (PC). In the last decades, several innovative technology applications have been introduced. 3-Dimensional conformal RT, volumetric/rotational intensity modulated RT associated or not with image-guided RT, are becoming largely diffused in the treatment of PC.BackgroundConsidering that PC could have a low α/β ratio, similar to late-reacting normal tissues, it could also be highly responsive to fraction size. Thus, the reduction of the number of fractions and the increase of the dose/fraction seem to be reasonable choices in the treatment of this cancer. This review reported the technology evolution, the radiobiological and the clinical data about the role of extreme hypofractionated RT in the treatment approach of PC patients.Materials and methodsMedline search and analysis of published studies containing key words: prostate cancer, radiotherapy, stereotactic radiotherapy.ResultsRecent technological developments, combined with an improved knowledge of the radiobiological models in favor of a high sensitivity of PC to larger fraction sizes are opening a new scenario in its treatment, reporting favorable efficacy and acceptable toxicity, despite short follow-up.ConclusionThus, thanks to technological improvement and the recent radiobiological data, "extreme hypofractionated RT" has been strongly introduced in the last years as a potential solid treatment option for PC.
| S-EPMC4661355 | biostudies-literature
Project description:Hypofractionation for prostate cancer was originally carried out in the pursuit of efficiency and convenience but has now attracted greatly renewed interest based upon a hypothesis that prostate cancers have a higher sensitivity to fraction size, reflected in a low alpha/beta ratio, than do late responding organs at risk such as the rectum or bladder. Tumor control and acceptable toxicity outcomes from several hypofractionation or brachytherapy analyses do in fact support an alpha/beta ratio for prostate cancer that is low, perhaps even lower that that for the normal organs that ordinarily constrain the delivery of radiation therapy. However, many of these studies lack sufficient patient numbers and follow-up, are clouded by dose inhomogeneity issues in the case of brachytherapy, or delivered effective doses that were too low by contemporary standards. Thus, the clinical efficacy of the approach has yet to be fully validated. However, a number of newer prospective trials, some randomized, are underway or have reached accrual but await sufficient follow-up for analysis. These studies, which cover a wide range of doses per fraction, should ultimately be capable of validating the utility of prostate hypofractionation and the models that predict its effects. With hypofractionation's significant potential for therapeutic gain, cost savings, and improved patient convenience, the future management of localized prostate cancer could be profoundly altered in the process.
| S-EPMC3039916 | biostudies-literature
Project description:The biologic effects of changing the daily radiation dose (fractionation) have been studied for more than a century. The fractionation question in the treatment of prostate cancer came into stark relief in 1999 with the publication of a provocative report suggesting that hypofractionated regimens could maintain the therapeutic ratio with logistic and financial advantages. In the last two decades medical evidence, weak and strong, has accumulated on the efficacy and toxicity of hypofractionated regimens in the radiotherapeutic treatment of prostate cancer. This brief review will focus on the results of randomized trials that compare moderate hypofractionation (HF) to conventional fractionation (CF). Extreme HF is covered in a separate review within this issue.
| S-EPMC6043742 | biostudies-literature
Project description:BackgroundExternal beam radiotherapy (EBRT) is a standard treatment for localized prostate cancer, with recent advancements favoring a reduced number of treatment sessions. Stereotactic body radiotherapy (SBRT) is a form of radiotherapy that delivers higher doses per fraction, typically in five or fewer sessions. This retrospective study aims to evaluate the implementation of the PACE-SBRT protocol for localized prostate cancer at our center by assessing the incidence and severity of toxicity, as well as biochemical relapse-free survival.MethodsWe conducted a retrospective analysis of patients with localized prostate cancer treated with SBRT at the Iridium Network in Antwerp, Belgium, who were treated between January 1, 2020, and December 31, 2022. Data were extracted from electronic medical records and included descriptive information on patient outcomes. Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Acute toxicity was defined as events occurring within 90 days post-SBRT, whereas late toxicity was evaluated at 6 months, 1 year, 2 years, and 3 years post treatment. Biochemical recurrence was defined via the Phoenix criteria, as a rise in PSA levels of 2 ng/mL or more above the post treatment nadir.ResultsA total of 267 patients met the eligibility criteria for this study. In total, 9% of patients were low risk, 51% were intermediate risk, and 40% were high risk. The cumulative incidence of Grade 2 or higher GU toxicity was 27%, and for GI toxicity, it was 2%. At 24 months, 11.5% (20/175) of patients experienced CTCAE grade 2 or higher GU toxicity, and 1.7% (3/175) experienced grade 2 or higher GI toxicity. Biochemical relapse occurred in 1.5% (4/267) of patients, leading to a 2-year biochemical relapse-free survival rate of 98.5%.ConclusionSBRT for localized prostate cancer has favorable oncological outcomes with a low incidence of Grade 2 or higher toxicity. The results of this study are consistent with findings from prospective trials, suggesting that SBRT is an effective treatment modality. Trial registration Retrospectively registered.
| S-EPMC11846345 | biostudies-literature
Project description: Not available
| S-EPMC7474808 | biostudies-literature
Project description:BackgroundWe performed a prospective phase II study to compare acute toxicity among five different hypofractionated schedules using proton therapy. This study was an exploratory analysis to investigate the secondary end-point of biochemical failure-free survival (BCFFS) of patients with long-term follow-up.MethodsEighty-two patients with T1-3bN0M0 prostate cancer who had not received androgen-deprivation therapy were randomized to one of five arms: Arm 1, 60 cobalt gray equivalent (CGE)/20 fractions/5 weeks; Arm 2, 54 CGE/15 fractions/5 weeks; Arm 3, 47 CGE/10 fractions/5 weeks; Arm 4, 35 CGE/5 fractions/2.5 weeks; and Arm 5, 35 CGE/5 fractions/4 weeks. In the current exploratory analysis, these ardms were categorized into the moderate hypofractionated (MHF) group (52 patients in Arms 1-3) and the extreme hypofractionated (EHF) group (30 patients in Arms 4-5).ResultsAt a median follow-up of 7.5 years (range, 1.3-9.6 years), 7-year BCFFS was 76.2% for the MHF group and 46.2% for the EHF group (p = 0.005). The 7-year BCFFS of the MHF and EHF groups were 90.5 and 57.1% in the low-risk group (p = 0.154); 83.5 and 42.9% in the intermediate risk group (p = 0.018); and 41.7 and 40.0% in the high risk group (p = 0.786), respectively. Biochemical failure tended to be a late event with a median time to occurrence of 5 years. Acute GU toxicities were more common in the MHF than the EHF group (85 vs. 57%, p = 0.009), but late GI and GU toxicities did not differ between groups.ConclusionsOur results suggest that the efficacy of EHF is potentially inferior to that of MHF and that further studies are warranted, therefore, to confirm these findings.Trial registrationThis study is registered at ClinicalTrials.gov, no. NCT01709253 ; registered October 18, 2012; retrospectively registered).
| S-EPMC6327508 | biostudies-literature
Project description:BackgroundFor prostate cancer treatment, treatment options with minimal side effects are desired. External beam radiation therapy (EBRT) is non-invasive, standard of care and delivered in either conventional fractionation over 8 weeks or with moderate hypo-fractionation over about 5 weeks. Recent advances in radiotherapy technology have made extreme hypo-fractionated stereotactic body radiation therapy (SBRT) of prostate cancer feasible, which has not yet been introduced as a standard treatment method in Germany. Initial results from other countries are promising, but long-term results are not yet available. The aim of this study is to investigate feasibility and effectiveness of SBRT for prostate cancer in Germany.Methods/designThis German bi-center single group trial (HYPOSTAT) is designed to evaluate feasibility and effectiveness, as measured by toxicity and PSA-response, respectively, of an extreme hypo-fractionated SBRT regimen with five fractions of 7 Gy in treatment of localized low and intermediate risk prostate cancer. The target volume includes the prostate with or without the base of seminal vesicles depending on risk stratification and uncertainty margins that are kept at 3-5 mm. SBRT treatment is delivered with the robotic CyberKnife system, which was recently introduced in Germany. Acute and late toxicity after one year will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE v. 4.0), Radiation Therapy Oncology Group (RTOG) and International Prostate Symptom Score (IPSS) Scores. The quality of life will be assessed before and after treatment with the EORTC QLQ C30 questionnaire. Hypothesizing that the proportion of patients with grade 2 side effects or higher is less or equal than 2.8%, thus markedly lower than the standard EBRT percentage (17.5%), the recruitment target is 85 patients.DiscussionThe HYPOSTAT trial aims at demonstrating short term feasibility of extreme hypo-fractioned SBRT for the treatment of prostate cancer and might be used as the pilot study for a multi-center multi-platform or for randomized-controlled trials comparing conventional radiotherapy with SBRT for localized prostate cancer in the future. The study concept of patient enrollment, follow up and evaluation by multiple public university clinics and actual patient treatment in dedicated private radiosurgery practices with high-tech radiation equipment is unique for clinical trials.Study statusThe study is ongoing and currently recruiting patients.Trial registrationRegistration number: NCT02635256 ( clinicaltrials.gov ). Registered 8 December 2015.
| S-EPMC5562995 | biostudies-literature
Project description:PurposeBoosting dominant intra-prostatic lesions (DILs) has the potential to increase the therapeutic ratio in prostate cancer radiotherapy. In this study, employing 5-fraction stereotactic ablative radiotherapy (SABR) volumetric modulated arc therapy (VMAT) to deliver 40 Gy to the prostate clinical target volume (CTV) while boosting the DIL up to 50 Gy was evaluated for patients before and after rectal spacer insertion.Materials and methods24 Computed Tomography (CT) scans of 12 prostate cancer patients with unfavourable intermediate or high risk prostate cancer were employed in this study. At least two treatment plans were generated for each patient to compare pre- and post-spacer insertion plans. Plans were evaluated for target coverage, organs-at-risk doses, and the achievable boost dose level.ResultsThe CTV coverage was significantly better in plans with a spacer, V40Gy 98.4% versus 97.0% (p = 0.012). Using spacers significantly reduced rectal dose in all 12 patients in this study. It was possible to boost DIL to 50 Gy to without violating dose constraints in 6 of 12 patients and to 47.5 Gy in 3 patients post-spacer insertion. For 3 patients (25%) it was not possible to boost DIL above 45 Gy even with a spacer in situ. Without a spacer, for 6 patient (50%) clinically acceptable plan were only achieved when the DIL dose was lowered to 45 Gy. In five of these 6 patients the dose limiting structure was the urethra (urethra planning risk volume V45Gy [cc] ≤ 0.1 cc constraint).ConclusionsClinically acceptable plans for 5 fraction SABR, 40 Gy to the prostate CTV, with a SIB to DIL (45-50 Gy) were achieved. The boost dose achieved was DIL location dependent and primarily affected by DIL's proximity to the urethra. Compared to plans before spacer insertion, higher DIL dose were achieved with spacer in situ for 25% of the patients. Moreover, significant reduction in rectal dose and better target coverage were also achieved for all patients with spacers in situ.
| S-EPMC8862253 | biostudies-literature
Project description:BackgroundLate urinary symptom flare has been shown to occur in a small subset of men treated with ultra- hypofractionated stereotactic body radiotherapy (SBRT) for prostate cancer. The purpose of this study was to use normal tissue complication probability modeling in an effort to derive SBRT specific dosimetric predictor's of late urinary flare.Material and methodsTwo hundred and sixteen men were treated for localized prostate cancer using ultra- hypofractionated SBRT. A dose of 35-36.25 Gy in 5 fractions was delivered to the prostate and proximal seminal vesicles. Functional surveys were conducted before and after treatment to assess late toxicity. Phenomenologic NTCP models were fit to bladder DVHs and late urinary flare outcomes using maximum likelihood estimation.ResultsTwenty-nine patients experienced late urinary flare within two years of completion of treatment. Fitting of bladder DVH data to a Lyman NTCP model resulted in parameter estimates of m, TD50, and n of 0.19 (0-0.47), 38.7 Gy (31.1-46.4), and 0.13 (-0.14-0.41), respectively. Subsequent fit to a hottest volume probit model revealed a significant association of late urinary flare with dose to the hottest 12.7% of bladder volume. Multivariate analysis resulted in a final model that included patient age and hottest volume probit model predictions. Kaplan-Meier analysis demonstrated a two-year urinary flare free survival of 95.7% in patients 65 years or older with a bladder D12.7% of 33.5 Gy or less, compared to 74.5% in patients meeting none of these criteria.ConclusionNTCP modeling of late urinary flare after ultra-hypofractionated prostate SBRT demonstrates a relatively small volume effect for dose to the bladder, suggesting that reduction of volume receiving elevated dose will result in decreased incidence of late urinary toxicity. Future studies will be needed to examine the impact of dose to other potential sources of late genitourinary toxicity.
| S-EPMC4986047 | biostudies-literature
Project description:External beam radiation therapy with conventional fractionation to a total dose of 76-80 Gy represents the most adopted treatment modality for prostate cancer. Dose escalation in this setting has been demonstrated to improve biochemical control with acceptable toxicity using contemporary radiotherapy techniques. Hypofractionated radiotherapy and stereotactic body radiation therapy have gained an increasing interest in recent years and they have the potential to become the standard of care even if long-term data about their efficacy and safety are not well established. Strong radiobiological basis supports the use of high dose for fraction in prostate cancer, due to the demonstrated exceptionally low values of α / β . Clinical experiences with hypofractionated and stereotactic radiotherapy (with an adequate biologically equivalent dose) demonstrated good tolerance, a PSA control comparable to conventional fractionation, and the advantage of shorter time period of treatment. This paper reviews the radiobiological findings that have led to the increasing use of hypofractionation in the management of prostate cancer and briefly analyzes the clinical experience in this setting.
| S-EPMC4066864 | biostudies-literature